Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding

Metrorrhagia Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled, 7 Cycle Duration (196 Days), Phase 3 Study to Investigate the Efficacy and Safety of Oral Estradiol Valerate / Dienogest Tablets for the Treatment of Heavy Menstrual Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638923
• Other study ID #: 91774
• Secondary ID: X311965
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2012
• Last updated: July 8, 2015
• Start date: June 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationPhilippines: Philippines Food and Drug AdministrationRussia: Ministry of Health of the Russian FederationThailand: Food and Drug AdministrationTaiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women 18 years or older in generally good health with a diagnosis of heavy menstrual bleeding without organic pathology, requesting contraception

• Willingness to use barrier contraception (e.g., condoms) from screening to study completion

• Willingness to use and collect sanitary protection (pads and tampons) provided by the sponsor and compatible with the alkaline hematin test throughout study completion

Exclusion Criteria:

• Current diagnosis of organic uterine bleeding

• History of endometrial ablation, or dilatation and curettage within 2 months of Visit 1.

• Clinically significant pelvic findings (whether or not confirmed by transvaginal ultrasound [TVU]).

• Clinically significant abnormal results of breast examination (breast palpation).

• Positive pregnancy test at Visit 1

• Less than three months since delivery, abortion, or lactation before to start Visit 1

• Other contraceptive methods

• Any disease or condition that may worsen under hormonal treatment

• Smokers over the age of 35

• Body mass index >32

Study Design

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

Related Conditions & MeSH terms

• Menorrhagia
• Metrorrhagia

Intervention

Drug:
• EV/DNG (Qlaira, Natazia, BAY86-5027)
2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placebo. A blister card consists of 28 pills, taken orally once a day for 7 cycles of 28 days each.
• placebo
Matching placebo to be taken orally daily for 7 cycles of 28 days each.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

China,  Philippines,  Russian Federation,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in Menstrual Blood Loss (MBL) at baseline and 90 days		90 day baseline period and 90 days during treatment period	No
Secondary	Proportion of subjects with successful treatment	Successful treatment is defined as no bleeding episode with MBL of 80 mL or more and a decrease to a value	90 days during treatment phase	No
Secondary	Percent change of MBL at baseline and 90 day period during treatment phase		Baseline and 90 days during treatment phase	No
Secondary	Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days)		Baseline and cycle 1, cycle 2, cycle 3, cycle 4, cycle 5, cycle 6, cycle 7	No
Secondary	Proportion of subjects with improvement in the investigator's global assessment scale on Day 84	Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.	Treatment day 84	No
Secondary	Proportion of subjects with improvement in the investigator's global assessment scale on Day 196	Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.	Treatment day 196	No
Secondary	Proportion of subjects with improvement in the subject's global assessment scale on Day 84	Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.	Treatment day 84	No
Secondary	Proportion of subjects with improvement in the subject's global assessment scale on Day 196	Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.	Treatment day 196	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability		Up to 12 months	Yes

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