FC Patch Comparator Study

Contraception Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185354
• Other study ID #: 91402
• Secondary ID: 2004-000821-3130
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: December 30, 2015
• Start date: November 2004
• Est. completion date: April 2006

Study information

• Verified date: December 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyAustria: Federal Ministry for Health and WomenFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Contraindications for using hormonal contraceptives

Study Design

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• BAY86-5016, SH P00331F
Drug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD)
• SH P00331N
Drug amount per patch: 0.6 mg EE2 + 6 mg NGM

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Finland,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding pattern and cycle control		13 cycles	No
Primary	Number of pregnancies		13 cycles	No
Secondary	Adverse events collection		13 cycles	Yes
Secondary	Endometrial biopsy		13 cycles	Yes
Secondary	Physical and gynecological exam		13 cycles	Yes

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