Ovulation Inhibition of Two 4-phasic Oral Contraceptive Regimens

Phase 2CompletedNCT00805415

Bayer209 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

209

Conditions

Ovulation Inhibition

Interventions

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

Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 2 and 3 mg

EV/DNG (SH T00658L)DRUG

Estradiol valerate (EV) and dienogest (DNG) in a sequential 4-phasic regimen, EV 3, 2, and 1 mg and DNG 3 and 4 mg

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Dinox GmbH Berlin

Berlin, State of Berlin, Germany

Dinox B.V.

Groningen, Netherlands

Outcomes

Primary Outcomes

Proportion of subjects with a Hoogland score of 5-6 (luteinized unruptured follicle [LUF] or ovulation)