Efficacy and Safety Study of an Oral Contraceptive in Healthy Females

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00206583

304742 (Other Identifier)

90959

Details and patient eligibility

About

The purpose of this study is to determine whether the study drug is safe and effective in the prevention of pregnancies in a large group of volunteers.

Full description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals Inc.. Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.

Enrollment: 499 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy women between the ages of 18 and 35 years requiring contraception

Exclusion criteria

• Pregnancy, lactation, and contraindication of combined oral contraceptive

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

499 participants in 1 patient group

EV/DNG (Qlaira, BAY86-5027)

Experimental group

Description:

Estradiolvalerate (EV)/Dienogest (DNG) Tablet p.o. (oral)

Treatment:

Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)