check_circleStudy Completed

Contraception

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
  • - Healthy female volunteer aged 18-35, smokers 18-30
  • - Contraindications for using hormonal contraceptives

Trial summary

Enrollment Goal
422
Trial Dates
November 2004 - April 2006
Phase
Phase 3
Could I Receive a placebo
No
Products
Gestodene/EE Patch (BAY86-5016)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
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
    date_rangeTime Frame:
    13 cycles
    enhanced_encryption
    Safety Issue:
    No
  • Number of pregnancies
    date_rangeTime Frame:
    13 cycles
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Adverse events collection
    date_rangeTime Frame:
    13 cycles
    enhanced_encryption
    Safety Issue:
    Yes
  • Endometrial biopsy
    date_rangeTime Frame:
    13 cycles
    enhanced_encryption
    Safety Issue:
    Yes
  • Physical and gynecological exam
    date_rangeTime Frame:
    13 cycles
    enhanced_encryption
    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
2