Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers

Condition(s) targeted: Contraception

Intervention: Yasmin 20 (Drug); Mercilon (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.

Official title: Open, Randomized, Parallel Multi-center Comparison of Cycle Control and Safety of the Oral Contraceptive Yasmin 20 in a 24-day Regimen vs. Mercilon for 7 Cycles in 440 Healthy Female Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Cycle control and bleeding pattern

Secondary outcome:

Pearl index

Laboratory tests

Adverse Events

General Physical and gynecological examinations

Vital signs

Body weight

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Healthy female volunteer aged 18-35,

- Smokers 18-30

Exclusion Criteria:

- Contraindications for using hormonal contraceptives

Horn 3580, Austria

Leibnitz 8430, Austria

Moedling 2340, Austria

St. Poelten 3100, Austria

Wien 1050, Austria

Woergl 6300, Austria

Paernu 80010, Estonia

Talinn 10145, Estonia

Tartu 51003, Estonia

Helsinki 00100, Finland

Helsinki 00260, Finland

Tampere 33200, Finland

Turku 20101, Finland

Kaunas 3042, Lithuania

Kaunas 3043, Lithuania

Vilnius 01118, Lithuania

Vilnius 2035, Lithuania

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Starting date: March 2004
Last updated: December 30, 2014