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OpenTrials
Completed

NCT Number: NCT00185354

FC Patch Comparator Study

The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.

Completed

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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

Wörgl, Tyrol, Austria

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About this study

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

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

BAY86-5016, SH P00331F

Drug

Drug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD)

SH P00331N

Drug

Drug amount per patch: 0.6 mg EE2 + 6 mg NGM

Primary outcomes

  1. Bleeding pattern and cycle control

    Time frame: 13 cycles

  2. Number of pregnancies

    Time frame: 13 cycles

Secondary outcomes

  1. Adverse events collection

    Time frame: 13 cycles

  2. Endometrial biopsy

    Time frame: 13 cycles

  3. Physical and gynecological exam

    Time frame: 13 cycles

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Multi-center, Open, Randomized, Parallel Group Comparison of Cycle Control for Seven Cycles and Endometrial Safety in a Subgroup for Thirteen Cycles of Contraceptive Patch SH P00331F (0.9 mg Ethinylestradiol/1.9 mg Gestodene) vs. a Contraceptive Comparator Patch (0.6 mg Ethinylestradiol/6 mg Norelgestromin) in 400 Healthy Female Volunteers

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 16, 2005
Registry last updated
Dec 31, 2015

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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