FC Patch Comparator Study

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185354

Enrollment

422

Registered

2005-09-16

Start date

2004-11-30

Completion date

2006-04-30

Last updated

2015-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Keywords

FC patch, comparator study

Brief summary

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

Detailed 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.

Interventions

DRUGBAY86-5016, SH P00331F

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

DRUGSH P00331N

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Contraindications for using hormonal contraceptives

Design outcomes

Primary

Measure	Time frame
Bleeding pattern and cycle control	13 cycles
Number of pregnancies	13 cycles

Secondary

Measure	Time frame
Adverse events collection	13 cycles
Endometrial biopsy	13 cycles
Physical and gynecological exam	13 cycles

Countries

Austria, Finland, France, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026