Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

Bayer

Status and phase: Completed; Phase 2

Conditions: Ovulation Inhibition

Treatments: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K); Drug: EV/DNG (SH T00658L)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00805415

91271

307300

Details and patient eligibility

About

The aim of the study is to investigate the ovulation inhibition of two 4-phasic oral contraceptive regimens.

Enrollment: 209 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy women willing to use non-hormonal methods of contraception

Exclusion criteria

• Women with any contraindication for oral contraceptive use, for example but not limited to: presence or history of venous or arterial thrombotic / thrombembolic events, hypertension, presence or history of severe hepatic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

209 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)

Arm 2

Experimental group

Treatment:

Drug: EV/DNG (SH T00658L)