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

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: EV/DNG (Qlaira, BAY86-5027)

• Registration Number: NCT01638910
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-12
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-16
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 955

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EV/DNG (Qlaira, BAY86-5027)	EV/DNG (Qlaira, BAY86-5027)	-

Primary Outcome Measures

Name	Time	Method
Number of unintended pregnancies	Up to Cycle 13 (1 Cycle = 28 days)

Secondary Outcome Measures

Name	Time	Method
Number of expected bleeding days	Up to Cycle 13 (1 Cycle = 28 days)
Number of unexpected bleeding episodes	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 days	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)