Study Completed

Contraception

Bayer Identifier:

91402

ClinicalTrials.gov Identifier:

NCT00185354

EudraCT Number:

2004-000821-31

EU CT Number:

Not Available

FC Patch comparator study

Trial purpose

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

Key Participants Requirements

Sex

Female

Age

18 - 35 Years

Trial summary

Enrollment Goal

422

Trial Dates

November 2004 - April 2006

Phase

Phase 3

Could I Receive a placebo

Products

Gestodene/EE Patch (BAY86-5016)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		Bregenz, 6900, Austria
Completed		Wien, 1030, Austria
Completed		Wörgl, 6300, Austria
Completed		Zeltweg, 8740, Austria
Completed		Graz, 8010, Austria
Completed		Wien, 1090, Austria
Completed		Helsinki, 00100, Finland
Completed		Helsinki, 00180, Finland
Completed		Turku, 20100, Finland
Completed		Turku, 20541, Finland
Completed		COMPIEGNE cedex, 60204, France
Completed		ROANNE, 42300, France
Completed		TOULOUSE, 31500, France
Completed		COMPIEGNE, 60200, France
Completed		Nancy Cedex, 54042, France
Completed		BIARRITZ, 64200, France
Completed		Bordeaux, 33000, France
Completed		Maisons lafitte, 78600, France
Completed		SAINT GERMAIN EN LAYE, 78100, France
Completed		Paris, 75018, France
Completed		Pantin, 93500, France
Completed		MONTARGIS, 45200, France
Completed		Guadalajara, 19002, Spain
Completed		Barcelona, 08006, Spain
Completed		Salt, 17190, Spain
Completed		Pontevedra, 36002, Spain
Completed		Santiago de Compostela, 15701, Spain
Completed		San Fernando, 11100, Spain

Primary Outcome

Bleeding pattern and cycle control
Time Frame:
13 cycles
Safety Issue:
No
Number of pregnancies
Time Frame:
13 cycles
Safety Issue:
No

Secondary Outcome

Adverse events collection
Time Frame:
13 cycles
Safety Issue:
Yes
Endometrial biopsy
Time Frame:
13 cycles
Safety Issue:
Yes
Physical and gynecological exam
Time Frame:
13 cycles
Safety Issue:
Yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Prevention

Allocation

Randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

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