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OpenTrials
Completed

NCT Number: NCT00624130

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

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

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Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Horn, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy female volunteer aged 18-35,
  • Smokers 18-30

Exclusion criteria

  • Contraindications for using hormonal contraceptives

Treatment and study plan

Yasmin 20

Drug

Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)

Mercilon

Drug

Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)

Primary outcomes

  1. Cycle control and bleeding pattern

    Time frame: 7 cycles

Secondary outcomes

  1. Pearl index

    Time frame: 7 cycles

  2. Laboratory tests

    Time frame: Screening

  3. Adverse Events

    Time frame: 7 cycles

  4. General Physical and gynecological examinations

    Time frame: Screening

  5. Vital signs

    Time frame: Screening, admission

  6. Body weight

    Time frame: Screening, admission

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
Feb 26, 2008
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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