LCS12 vs Combined Oral Contraceptive (COC) User Satisfaction Study

Contraception Clinical Trial

Official title:

Multicenter, Randomized, Open-label, Parallel-group Study to Evaluate User Satisfaction With and Tolerability of the Low-dose Levonorgestrel (LNG) Intrauterine Delivery System (IUS) With 12 µg LNG/Day Initial in Vitro Release Rate (LCS12) in Comparison to a Combined Oral Contraceptive Containing 30 µg Ethinyl Estradiol and 3 mg Drospirenone (Yasmin®) in Young Women (18-29 Years) Over 18 Months of Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254292
• Other study ID #: 13362
• Secondary ID: 2010-020181-21
• Status: Completed
• Phase: Phase 3
• First received: November 22, 2010
• Last updated: August 24, 2017
• Start date: January 6, 2011
• Est. completion date: May 28, 2014

Study information

• Verified date: August 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate user satisfaction and tolerability in young women (18-29 years of age) using the LCS12 compared with young women using a COC (Yasmin) over a period of 18 months. Subjects in the LCS12 arm will be offered continued use of LCS12 for the full, intended duration of use (up to 3 years) by continuing in a optional, extension phase. Safety data only will be collected during the extension phase of the study.

Secondary objectives are to observe the tolerability, discontinuation rates, adverse event profiles, occurrences of unintended pregnancies (including calculation of Pearl Index [PI]), and bleeding profiles with the two birth-control methods. Additionally, data on missed tablets in the combined oral contraceptive (COC) group, and intrauterine delivery system (IUS) expulsions in the LCS12 group will be recorded. In the LCS12 group, physician satisfaction with the IUS inserter, evaluation of the visibility and texture of the removal threads, and evaluation of the visibility of the LCS12 on ultrasound (in a subset of subjects) will be collected. Finally, in the COC group, information will be collected on the psychosocial impact of missed or delayed pill intake.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: May 28, 2014
• Est. primary completion date: January 8, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 29 Years

Eligibility

Inclusion Criteria:

• Subject has signed and dated the Informed Consent Form (ICF).

• The subject is generally healthy, requesting contraception, and is between 18 and 29 years of age (inclusive) at Screening.

• In the opinion of the investigator, the subject is

• in good health;

• without uterine conditions that would preempt insertion of LCS12;

• without conditions/history that would contraindicate the use of oral contraceptives.

• Subject has normal or clinically insignificant cervical smear (ie, one that does not require further follow up). A cervical smear must be taken at the Screening Visit or a documented normal result has to have been obtained within 6 months of Screening. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) deoxyribonucleic acid (DNA) test that, according to the standards of the local laboratory, is negative for high-risk HPV.

• As determined by subject's history, subject has regular (ie, endogenous cyclicity without hormonal contraceptive use) menstrual cycles (length of cycle 21-35 days).

• Subject is willing and able to attend the scheduled study visits and to comply with the study procedures.

Exclusion Criteria:

• Pregnancy or current lactation (less than 6 weeks since vaginal or Cesarean delivery or abortion). Note: Postpartum LCS12 insertions should be postponed until the uterus is fully involuted, and not earlier than 6 weeks after delivery. If involution is substantially delayed, the investigator should consider waiting until 12 weeks postpartum.

• Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit (Visit 1)

• Chronic, daily use of drugs that may increase serum potassium levels, such as nonsteroidal anti-inflammatory drugs (NSAIDs, eg. ibuprofen and naproxen), potassium-sparing diuretics (eg. spironolactone), potassium supplementation, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, aldosterone antagonists, and heparin.

• Abnormal uterine bleeding of unknown origin/undiagnosed abnormal genital bleeding

• Any genital infection (until successfully treated)

• Abnormal cervical smear result (see inclusion criteria)

• Acute, current or history of recurrent pelvic inflammatory disease

• Congenital or acquired uterine anomaly or any distortion of the uterine cavity (eg, by fibroids) that, in the opinion of the investigator, would cause problems during insertion, retention, or removal of LCS12.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Levonorgestrel IUD (LCS, BAY86-5028)
LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 18 months with optional extension to 36 months for subjects in this group only.
• Yasmin (EE30/DRSP, BAY86-5131)
Combined oral contraceptive (COC; Yasmin; 0.03 mg ethinyl estradiol and 3 mg drospirenone); Subjects will start taking COC at / on the day of visit 2 and continue taking one pill / day without any breaks for the entire study duration of 18 months.

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Bregenz	Bregenz	Vorarlberg
Austria	Praxis Dr. Hannes Kahr	Graz
Austria	Dr. Bernhard Svejda	Klagenfurt
Austria	Ordination Dr. Schmidl-Amann	St. Pölten	Niederösterreich
Austria	Ordination Dr. Sator	Tulln
Austria	Ordination Dr. Trost	Voitsberg	Steiermark
Austria	Dr. Brigitte Wiesenthal	Wien
Austria	Dr. Wolfgang Bartl	Wien
Austria	Dr. Max Stiglbauer	Wiener Neustadt	Niederösterreich
Austria	Dr. Walter Paulik	Zeltweg
Belgium	Dr. Philip Loquet	Antwerpen
Belgium	Hôpital Erasme/Erasmus Ziekenhuis	Bruxelles-brussel
Belgium	Gynaecologen Noord Antwerpen	Ekeren
Belgium	UZ Gent	Gent
Belgium	UZ Leuven Gasthuisberg	Leuven
Germany	Praxis f. Gynäkologie und Geburtshilfe	Bernburg	Sachsen-Anhalt
Germany	Frauenarztpraxis Dr. Wetzel	Blankenburg	Sachsen-Anhalt
Germany	Frauenarztpraxis Dr. Robert Hantschel	Dippoldiswalde	Sachsen
Germany	Praxis Hr. Dr. U. Kopprasch	Dresden	Sachsen
Germany	Praxis Hr. Dr. A. Soder	Ettlingen	Baden-Württemberg
Germany	Praxis Hr. Dr. E. Goeckeler-Leopold	Geseke	Nordrhein-Westfalen
Germany	Praxis Hr. Dr. D. Rautenberg	Hamburg
Germany	Praxis Hr. Dr. K. Buehling	Hamburg
Germany	Praxis Hr. Dr. K. Peters	Hamburg
Germany	Praxis Hr. Dr. K. Greven	Hannover	Niedersachsen
Germany	Praxis Hr. H. Thelen	Jessen	Sachsen-Anhalt
Germany	Evangelisches Krankenhaus Köln Weyertal gGmbH	Köln	Nordrhein-Westfalen
Germany	Frauenarztpraxis Dr. Bernd Pittner	Leipzig	Sachsen
Germany	Praxis Fr. C. Burgkhardt	Leipzig	Sachsen
Germany	Praxis Fr. Dr. A. Braune	Magdeburg	Sachsen-Anhalt
Russian Federation	Altai State Medical University	Barnaul
Russian Federation	Scientific Center of family health & human reprod. problems	Irkutsk
Russian Federation	Instit. of Motherhood & Childhood care n.a. Gorodkov	Ivanovo
Russian Federation	City Perinatal Center	Novosibirsk
Russian Federation	Institute of Obsteric & Gyn.	St. Petersburg
United States	Boston Medical Center	Boston	Massachusetts
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Columbus Center for Women's Health Research	Columbus	Ohio
United States	Advanced Research Associates	Corpus Christi	Texas
United States	Grossmont Center for Clinical Research	La Mesa	California
United States	Women's Clinic of Lincoln, PC	Lincoln	Nebraska
United States	Clinical Research of Philadelphia, LLC	Philadelphia	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Genesis Center for Clinical Research	San Diego	California
United States	Medical Center for Clinical Research	San Diego	California
United States	Seattle Women's: Health, Research, Gynecology	Seattle	Washington
United States	Visions Clinical Research - Tucson	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Germany,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cumulative Number of Participants With Partial or Total Expulsion	Total expulsion is confirmed if the IUS is observed in the vagina, the IUS is not shown in the uterine cavity by ultrasound, and / or the subject confirms that the system was expelled. Partial expulsion is diagnosed if the IUS can be partially seen in the vagina or is displaced in the cervical canal.	Up to 18, 24, 36 months
Other	Investigator's Evaluation of Successful IUS Insertion Procedure		Up to 18 months
Other	Participants' Evaluation of Pain During Successful IUS Insertion Procedure		Up to 18 months
Other	Investigator's Evaluation of IUS Removal Procedure		Up to 36 months
Other	Participants' Evaluation of Pain During IUS Removal Procedure		Up to 36 months
Primary	Overall Satisfaction Rate at 18 Months (Last Observation Carried Forward, LOCF)	Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.	At 18 months
Secondary	Overall Satisfaction Rating by the 5-point Likert Item at 6 Months	Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.	At 6 months
Secondary	Overall Satisfaction Rating by the 5-point Likert Item at 12 Months	Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.	At 12 months
Secondary	Overall Satisfaction Rating by the 5-point Likert Item at 18 Months	Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.	At 18 months
Secondary	Overall Satisfaction Rating by the 5-point Likert Item at End of Study (EOS)	Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.; The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.	At 18 months/EOS
Secondary	Overall Satisfaction Rate at 6 Months (LOCF)	Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.	At 6 months
Secondary	Overall Satisfaction Rate at 12 Months (LOCF)	Satisfaction was to be assessed by the subject based on a 5-point Likert item, using the following question: How satisfied are you with the birth control method used during the study? 1. Very satisfied 2. Satisfied 3. Neither satisfied nor dissatisfied 4. Dissatisfied 5. Very dissatisfied The overall satisfaction rate was to be the percentage of subjects selecting "1. Very satisfied" or "2. Satisfied" for the above question.	At 12 months
Secondary	User Satisfaction - Acceptability of the Administration of Study Treatment	The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.	At 18 months/EOS
Secondary	User Satisfaction - Choices Upon Completion of the Study	The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.	At 18 months/EOS
Secondary	User Satisfaction - Amount of Menstrual Bleeding	The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.	At 18 months/EOS
Secondary	User Satisfaction - Satisfaction With Menstrual Bleeding Pattern	The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.	At 18 months/EOS
Secondary	User Satisfaction - Frequency of Experiencing Unexpected Bleeding	The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.	At 18 months/EOS
Secondary	User Satisfaction - Satisfaction With Menstrual Bleeding Absence	The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.	At 18 months/EOS
Secondary	User Satisfaction - Comparison of Menstrual Pain Intensity Between Now and Before Treatment	The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.	At 18 months/EOS
Secondary	User Satisfaction - Rating of Usual Menstrual Pain Intensity	The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.	At 18 months/EOS
Secondary	EVAPIL-R Scores at Screening - Composite Score	The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.	At screening
Secondary	EVAPIL-R Scores at Screening - Bother Score	The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, , with higher values indicating more severe symptoms/less tolerability.	At screening
Secondary	EVAPIL-R Scores at 6 Months	The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.	At 6 months
Secondary	EVAPIL-R Scores at 12 Months - Bother Score	The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.	At 12 months
Secondary	EVAPIL-R Scores at 12 Months - Composite Score	The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability.	At 12 months
Secondary	EVAPIL-R Scores at 18 Months/EOS	The EVAPIL-R scale is a self-questionnaire aimed to assess tolerability of oral contraceptives. A composite score was derived from 16 items and the ratings for presence/absence (rated as 1/0), frequency (rated with values from 0 to 2), intensity (rated from 1 to 3) and bother (rated from 1 to 4) for each item. To calculate the composite score, the bother rating of each item was multiplied by an item- specific multiplier and a weight. Range is 0-12, with higher values indicating more severe symptoms/less tolerability. The 18-month Treatment Visit served as the End-of-Study (EOS) Visit for participant in the COC group and LCS12 participant who did not enter the Extension Phase.	At 18 months/EOS
Secondary	Cumulative Drop-out Rate	The drop-out rate is the amount of participants that could not complete the study for various reasons. Discontinuation rates due to the following reasons and overall discontinuations were calculated: • LCS12 expulsions • Bleeding pattern alterations • Bleeding pattern alterations with increased bleeding (amount) • Bleeding pattern alterations with decreased bleeding (amount) • Adverse Events The analyses described above were also done by parity. Furthermore, overall discontinuation rates were analyzed by Kaplan-Meier analyses and presented as cumulative half-yearly drop-out rates.	Up to 6, 12, 18, 24 and 36 months
Secondary	Pearl Index (PI)	The Pearl Index was defined as the number of pregnancies per 100 woman years (WYs). Given the assumption that the number of pregnancies follows a Poisson distribution, the Pearl Index thus is the mean of this distribution.	Up to 18, 24, 36 months
Secondary	Compliance Rate for Yasmin Pill Intake		Up to 18 months
Secondary	User Satisfaction - Acceptability of the Administration of Study Treatment	The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.	At 6 months
Secondary	User Satisfaction - Acceptability of the Administration of Study Treatment	The degree of user satisfaction was assessed at the end-of-study visit using an eight item questionnaire. One of the items assessed was acceptability of study treatment which was categorized into the following: acceptable without I/D, acceptable with some I/D, not acceptable with moderate I/D, and not acceptable with extreme I/D.	At 12 months

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