Effects of SH T00658ID on Libido

Contraception Clinical Trial

Official title:

Multi-center, Double-blind, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive Containing Estradiol Valerate and Dienogest (SH T00658ID) Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (Microgynon) Over 6 Treatment Cycles on Alleviating Complaints of Reduced Libido in Women With Acquired Female Sexual Dysfunction (FSD) Associated With Oral Contraceptive Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764881
• Other study ID #: 91548
• Secondary ID: 2008-002263-1331
• Status: Completed
• Phase: Phase 3
• First received: October 1, 2008
• Last updated: December 8, 2014
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical DevicesItaly: Ethics CommitteeSpain: Spanish Agency of MedicinesThailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year will express the same level of sexual distress when taking SH T00658ID compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than one year and willingness to continue OC use but to switch to SH T00658ID or Microgynon

• Combined score of the sexual desire and arousal domains of the FSFI questionnaire of 18 or below at screening and baseline

Exclusion Criteria:

• Contraindications for oral contraceptive use, for example but not limited to:

presence or history of venous or arterial thrombotic / thromboembolic events, hypertension, presence or history of severe hepatic disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Contraception
• Libido

Intervention

Drug:
• EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated SH T00658ID for 28 days per cycle, for 6 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo, encapsulated for blinding purpose
• Microgynon
Days 1 to 21: daily oral administration of one encapsulated Microgynon tablet; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Six 28-day treatment cycles.
• Placebo
Days 22 to 28: daily oral administration of one encapsulated placebo tablet. Six 28-day treatment cycles.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Sydney Centre for Reproductive Health Reseach	Ashfield	New South Wales
Australia	Queen Elizabeth II Medical Centre	Nedlands	Western Australia
Australia	The Alfred Hospital	Prahran	Victoria
Australia	King Edward Memorial Hospital	Subiaco	Western Australia
Australia	Royal Hospital for Women	Sydney	New South Wales
Austria	Ordination Dr. Schaffer	Graz	Steiermark
Austria	Ordination Dr.Hohlweg	Graz	Steiermark
Austria	Ordination Dr. Schmidl-Amann	St. Pölten	Niederösterreich
Austria	Clin Pharm International GmbH Studienzentrum Wien	Wien
Austria	Dr. Brigitte Wiesenthal	Wien
Austria	Dr. Wolfgang Bartl	Wien
Austria	Dr. Walter Paulik	Zeltweg
Belgium	Hôpital Erasme/Erasmus Ziekenhuis	Bruxelles - Brussel
Belgium	UZ Gent	Gent
Belgium	UZ Leuven Gasthuisberg	Leuven
Germany	Universitätsklinikum Aachen	Aachen	Nordrhein-Westfalen
Germany	Universitätsklinikum Freiburg	Freiburg	Baden-Württemberg
Germany	Praxis Dr. A. Schwenkhagen-Stodieck	Hamburg
Germany	Frauenarztpraxis Dr. Bernd Pittner	Leipzig	Sachsen
Italy	A.O.U. Policlinico - Vittorio Emanuele	Catania
Italy	A.O.U. di Cagliari	Monserrato	Cagliari
Italy	IRCCS Fondazione Maugeri - Montescano (Pavia)	Pavia
Italy	A.O.U. Pisana	Pisa
Spain	Centro de Planificacion Familiar Alicante 3	Alicante
Spain	USP Institut Universitari Dexeus	Barcelona
Spain	Diatros Gava- Centre Assistencial Ntra. Sra. de Burgues	Gava	Barcelona
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Instituto Palacios de Salud y Medicina de la Mujer	Madrid
Thailand	Chulalongkorn Hospital	Bangkok
Thailand	Ramathibodhi Hospital	Bangkok
Thailand	Siriraj Hospital, Mahidol	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Germany,  Italy,  Spain,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Full Analysis Set (FAS)	Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Primary	Change From Baseline to Cycle 6 in the Total of Questions 1 to 6 of the Female Sexual Function Index (FSFI) - Per Protocol Set (PPS)	Change from Baseline FSFI domains in desire and arousal component scores at Cycle 6. The change in score ranges from -28 (worst) to 28 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of FSFI Domain Score (Desire) at Baseline	Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Baseline. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).	At Baseline	No
Secondary	The Mean Absolute Values of FSFI Domain Score (Desire) at Cycle 6	Sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire at Cycle 6. The normalized score for those 2 questions ranges from 1.2 (worst) to 6 (best).	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Desire)	Mean change from Baseline to Cycle 6 in the sum of questions 1 and 2 on sexual desire on the FSFI Questionnaire. The change in the normalized score for those 2 questions ranges from -4.8 (worst) to 4.8 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of FSFI Domain Score (Arousal) at Baseline	Sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).	At Baseline	No
Secondary	The Mean Absolute Values of FSFI Domain Score (Arousal) at Cycle 6	Sum of questions 3 to 6 on sexual arousal on FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Arousal)	Mean change from Baseline to Cycle 6 in the sum of questions 3 to 6 on sexual arousal on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of FSFI Domain Score (Lubrication) at Baseline	Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Baseline. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).	At Baseline	No
Secondary	The Mean Absolute Values of FSFI Domain Score (Lubrication) at Cycle 6	Sum of questions 7 to 10 on lubrication on the FSFI Questionnaire at Cycle 6. The normalized score for those 4 questions ranges from 0 (worst) to 6 (best).	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Lubrication)	Mean change from Baseline at Cycle 6 in the sum of questions 7 to 10 on the FSFI Questionnaire. The change in the normalized score for those 4 questions ranges from -6 (worst) to 6 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of FSFI Domain Score (Orgasm) at Baseline	Sum of questions 11 to 13 on orgasm on FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).	At Baseline	No
Secondary	The Mean Absolute Values of FSFI Domain Score (Orgasm) at Cycle 6	Sum of questions 11 to 13 on orgasm on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Orgasm)	Mean change from Baseline to Cycle 6 in the sum of questions 11 to 13 on orgasm on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Baseline	Sum of Questions 14 to 16 on satisfaction on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).	At Baseline	No
Secondary	The Mean Absolute Values of FSFI Domain Score (Satisfaction) at Cycle 6	Sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0.8 (worst) to 6 (best).	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Satisfaction)	Mean change from Baseline to Cycle 6 in the sum of questions 14 to 16 on satisfaction on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -5.2 (worst) to 5.2 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of FSFI Domain Score (Pain) at Baseline.	Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Baseline. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).	At Baseline	No
Secondary	The Mean Absolute Values of FSFI Domain Score (Pain) at Cycle 6	Sum of questions 17 to 19 on pain on the FSFI Questionnaire at Cycle 6. The normalized score for those 3 questions ranges from 0 (worst) to 6 (best).	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in FSFI Domain Score (Pain)	Mean change from Baseline to Cycle 6 in the sum of questions 17 to 19 on pain on the FSFI Questionnaire. The change in the normalized score for those 3 questions ranges from -6 (worst) to 6 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of FSFI Total Score at Baseline	The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).	At Baseline	No
Secondary	The Mean Absolute Values of FSFI Total Score at Cycle 6	The normalized FSFI total score was the weighted sum of the domain scores covering a range from 2 (worst) to 36 (best).	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in FSFI Total Score	The change in the normalized FSFI total score ranges from -34 (worst) to 34 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Baseline	Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).	At Baseline	No
Secondary	The Mean Absolute Values of Female Sexual Distress Scale (FSDS-R) Total Score at Cycle 6	Validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The total score ranges from 0 (worst) to 52 (best).	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in Female Sexual Distress Scale (FSDS-R) Total Score	Change from Baseline to Cycle 6 in the validated, 13-item scale (0=never to 4=always) that assesses subjective distress associated with sexual dysfunction in women. A decrease in the total score=decrease in frequency of the subjective distress symptom. The change in total score ranges from -52 (best) to 52 (worst).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Baseline	Q-LES-Q (short version - 16 items) assessed at Baseline the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).	At Baseline	No
Secondary	The Mean Absolute Values of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score at Cycle 6	Q-LES-Q (short version - 16 items) assessed at Cycle 6 the degree of enjoyment and satisfaction during the past week taking everything into consideration on a 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best).	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (Short Version) Total Score	Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the QLES-Q (short version - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Baseline	The PGWBI measured at Baseline self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant	At Baseline	No
Secondary	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) Global Score at Cycle 6	The PGWBI measured at Cycle 6 self-representations over the past 4 weeks of intrapersonal affective or emotional states reflecting a sense of subjective well-being or distress. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the well-being of the participant	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) Global Score	Change from Baseline to Cycle 6 in the PGWBI Questionnaire's assessment of the participant's overall sense of well-being or distress. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Baseline	Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Baseline	No
Secondary	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Anxiety at Cycle 6	Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Anxiety	Anxiety is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - Anxiety score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Baseline	Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Baseline	No
Secondary	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Depressed Mood at Cycle 6	Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Depressed Mood	Depressed mood is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - depressed mood score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Baseline	Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Baseline	No
Secondary	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Positive Well-being at Cycle 6	Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Positive Well-being	Positive well-being is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - positive well-being score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Baseline	Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Baseline	No
Secondary	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Self-control at Cycle 6	Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Self-control	Self-control is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - self-control score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Baseline	General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Baseline	No
Secondary	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - General Health at Cycle 6	General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - General Health	General health is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale the change in the normalized PGWBI general health score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Baseline	Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Baseline	No
Secondary	The Mean Absolute Values of Psychological General Well-Being Index (PGWBI) - Vitality at Cycle 6	Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the range of PGWBI scores were normalized from 0 to 100. The higher the score, the better the wellbeing of the participant.	At Cycle 6 (28 days per Cycle)	No
Secondary	Mean Change From Baseline to Cycle 6 in Psychological General Well-Being Index (PGWBI) - Vitality	Vitality is 1 of 6 dimensions of the PGWBI self-report questionnaire used to measure the subjective well-being or distress of the participant. The response format used a 6-grade Likert scale and the change in the normalized PGWBI - vitality score ranges from -100 (worst) to 100 (best).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	Percentage of Participants With Improvement in the Investigator's Assessment in Clinical Global Impression (CGI) at Cycle 6	CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.	At Cycle 6 (28 days per Cycle)	No
Secondary	Percentage of Participants With Improvement in Participant's Assessment in Clinical Global Impression (CGI) at Cycle 6	In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement.	At Cycle 6 (28 days per Cycle)	No
Secondary	Vaginal Effects Evaluated by Vaginal pH at Cycle 6	Vaginal pH (0 to 6) measured by subject using a pH indicator dipstick	At Cycle 6 (28 days per Cycle)	No
Secondary	Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Baseline	ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).	At Baseline	No
Secondary	Vaginal Effects Evaluated by the Mean Absolute Values of Atrophy Symptom Questionnaire (ASQ) at Cycle 6	ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe).	At Cycle 6 (28 days per Cycle)	No
Secondary	Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Atrophy Symptom Questionnaire (ASQ)	ASQ consists of 5 items which define the status of the vagina. The response format uses a 4-point scale from 0 (none) to 3 (severe). The change in average score ranges from -3 (best) to 3 (worst).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Baseline	The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).	At Baseline	No
Secondary	Vaginal Effects Evaluated by the Mean Absolute Values of Vaginal Health Assessment (VHA) at Cycle 6	The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5).	At Cycle 6 (28 days per Cycle)	No
Secondary	Vaginal Effects Evaluated by the Mean Change From Baseline to Cycle 6 in Vaginal Health Assessment (VHA)	The VHA, performed by the Investigator during gynecological exam, is the average of 5 individual scores related to composition and appearance of the vagina (secretions, epithelial integrity, epithelial surface thickness, color, and pH) scored from 0 (no atrophy or pH<4) to 3 (severe or pH5). The change in average score ranges from -3 (best) to 3 (worst).	Baseline up to Cycle 6 (28 days per Cycle)	No
Secondary	Number of Bleeding / Spotting Days in Reference Period 1	Reference Period 1 is defined as Day 1 to 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90	No
Secondary	Number of Bleeding / Spotting Days in Reference Period 2	Reference Period 2 is defined as Day 91 to 180 during study treatment	From Day 91 to Day 180	No
Secondary	Number of Bleeding / Spotting Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the fist treatment cycle includes 2 bleeding episodes	From Day 1 to Day 90	No
Secondary	Number of Bleeding / Spotting Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment	From Day 91 to Day 180	No
Secondary	Mean Length of Bleeding / Spotting Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes	From Day 1 to Day 90	No
Secondary	Mean Length of Bleeding / Spotting Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180	No
Secondary	Maximum Length of Bleeding / Spotting Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90	No
Secondary	Maximum Length of Bleeding / Spotting Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180	No
Secondary	Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90	No
Secondary	Difference in Duration Between Longest and Shortest Bleeding / Spotting Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180	No
Secondary	Number of Spotting Only Days in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90	No
Secondary	Number of Spotting Only Days in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180	No
Secondary	Number of Spotting Only Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90	No
Secondary	Number of Spotting Only Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180	No
Secondary	Mean Length of Spotting-only Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90	No
Secondary	Mean Length of Spotting-only Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180	No
Secondary	Maximum Length of Spotting-only Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90	No
Secondary	Maximum Length of Spotting-only Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180	No
Secondary	Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 1	Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes.	From Day 1 to Day 90	No
Secondary	Difference in Duration Between Longest and Shortest Spotting-only Episodes in Reference Period 2	Reference Period 2 is defined as Day 91 to Day 180 during study treatment.	From Day 91 to Day 180	No
Secondary	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 1	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end	At Cycle 1 (28 days per Cycle)	No
Secondary	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 3	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end	At Cycle 3 (28 days per Cycle)	No
Secondary	Percentage of Participants With / Without Withdrawal Bleeding at Cycle 6	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end	At Cycle 6 (28 days per Cycle)	No
Secondary	Length of Withdrawal Bleeding Episodes at Cycle 1	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end	At Cycle 1 (28 days per Cycle)	No
Secondary	Length of Withdrawal Bleeding Episodes at Cycle 3	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end	At Cycle 3 (28 days per Cycle)	No
Secondary	Length of Withdrawal Bleeding Episodes at Cycle 6	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end	At Cycle 6 (28 days per Cycle)	No
Secondary	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.	At Cycle 1 (28 days per Cycle)	No
Secondary	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.	At Cycle 3 (28 days per Cycle)	No
Secondary	Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	Intensity was rated as 1=spotting; 2=light; 3=normal or 4=heavy.	At Cycle 6 (28 days per Cycle)	No
Secondary	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 1	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.	At Cycle 1 (28 days per Cycle)	No
Secondary	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 3	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.	At Cycle 3 (28 days per Cycle)	No
Secondary	Percentage of Participants by Maximum Intensity of Withdrawal Bleeding Episodes at Cycle 6	Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. Intensity rated on 4-point scale from 1=spotting to 4=heavy.	At Cycle 6 (28 days per Cycle)	No
Secondary	Onset of Withdrawal Bleeding Episodes at Cycle 1	Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.	From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 1	No
Secondary	Onset of Withdrawal Bleeding Episodes at Cycle 3	Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.	From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 3	No
Secondary	Onset of Withdrawal Bleeding Episodes at Cycle 6	Onset of withdrawal bleeding was calculated from the end of the exposure to the progestogen component (Day 24 for EV/DNG and Day 21 for EE/LNG). Therefore the count for the onset started at each Cycle on Day 25 for EV/DNG and Day 22 for EE/LNG.	From Day 24 for EV/DNG and Day 21 for EE/LNG to Day 28 for Cycle 6	No
Secondary	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 1	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 1 (28 days per Cycle)	No
Secondary	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 3	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 3 (28 days per Cycle)	No
Secondary	Percentage of Participants With Presence or Absence of Intracyclic Bleeding at Cycle 6	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 6 (28 days per Cycle)	No
Secondary	Number of Intracyclic Bleeding Episodes at Cycle 1	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 1 (28 days per Cycle)	No
Secondary	Number of Intracyclic Bleeding Episodes at Cycle 3	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 3 (28 days per Cycle)	No
Secondary	Number of Intracyclic Bleeding Episodes at Cycle 6	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 6 (28 days per Cycle)	No
Secondary	Maximum Length of Intracyclic Bleeding Episodes at Cycle 1	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 1 (28 days per Cycle)	No
Secondary	Maximum Length of Intracyclic Bleeding Episodes at Cycle 3	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 3 (28 days per Cycle)	No
Secondary	Maximum Length of Intracyclic Bleeding Episodes at Cycle 6	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 6 (28 days per Cycle)	No
Secondary	Number of Intracyclic Bleeding Days at Cycle 1	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 1 (28 days per Cycle)	No
Secondary	Number of Intracyclic Bleeding Days at Cycle 3	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 3 (28 days per Cycle)	No
Secondary	Number of Intracyclic Bleeding Days at Cycle 6	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	At Cycle 6 (28 days per Cycle)	No
Secondary	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 1	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.	At Cycle 1 (28 days per Cycle)	No
Secondary	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 3	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.	At Cycle 3 (28 days per Cycle)	No
Secondary	Percentage of Participants by Maximum Intensity of Intracyclic Bleeding Episodes at Cycle 6	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity rated on 4-point scale where 1=spotting; 2=light; 3=normal; and 4=heavy.	At Cycle 6 (28 days per Cycle)	No
Secondary	Percentage of Participants With at Least 1 Intracyclic Bleeding Episode	Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens.	Up to Cycle 6 (28 days per Cycle)	No

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