Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female Subjects

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in healthy female subjects.

Official Title
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A Multi-center, Open, Uncontrolled Phase 3 Study to Investigate the Efficacy and Safety of a 4-phasic Oral Contraceptive SH T00658ID Containing Estradiol Valerate and Dienogest in a 28-day Regimen for 13 Cycles in Healthy Female Subjects

Conditions
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Contraception

Intervention / Treatment
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* Drug: EV/DNG (Qlaira, BAY86-5027)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy women between 18 and 50 for the entire study, except women enrolled from India should be aged between 18 and 40 years, requesting contraception Smokers may not exceed 35 years of age Exclusion Criteria: Pregnancy or lactation (delivery, abortion, or lactation within less than three cycles before the start of treatment) Body mass index (BMI) > 32 kg/m2 Any disease or condition that may worsen under hormonal treatment Undiagnosed abnormal genital bleeding Other contraceptive methods such as sterilization, hormonal contraception, IUD within 30 days of Visit 1, monthly contraceptive injection within a period of three times of the injection interval before start of treatment Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EV/DNG (Qlaira, BAY86-5027)<br> | Drug: EV/DNG (Qlaira, BAY86-5027)<br>* Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2 days placebo), one table oral daily for 13 treatment cycles (1 cycle = 28days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of unintended pregnancies |  | Up to Cycle 13 (1 Cycle = 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of expected bleeding days |  | Up to Cycle 13 (1 Cycle = 28 days) | 
| Number of unexpected bleeding days |  | Up to Cycle 13 (1 Cycle = 28 days) | 
| Number of expected bleeding episodes |  | Up to Cycle 13 (1 Cycle = 28 days) | 
| Number of unexpected bleeding episodes |  | Up to Cycle 13 (1 Cycle = 28 days) | 
| Number of participants with Adverse Events as a Measure of Safety and Tolerability |  | Up to Cycle 13 (1 Cycle = 28 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy, Safety, oral contraception, estradiol valerate, dienogest