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

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: EV/DNG (Qlaira, BAY86-5027)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01638910

91773

Details and patient eligibility

About

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

Enrollment: 955 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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955 participants in 1 patient group

EV/DNG (Qlaira, BAY86-5027)

Experimental group

Treatment:

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