Trial Condition(s):
Contraception
FC Patch comparator study
Bayer Identifier:
91402
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.
Inclusion Criteria
- Healthy female volunteer aged 18-35, smokers 18-30
Exclusion Criteria
- Contraindications for using hormonal contraceptives
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Bregenz, Austria, 6900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wörgl, Austria, 6300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zeltweg, Austria, 8740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Graz, Austria, 8010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Helsinki, Finland, 00180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland, 20100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Turku, Finland, 20541 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site COMPIEGNE cedex, France, 60204 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site ROANNE, France, 42300 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site TOULOUSE, France, 31500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site COMPIEGNE, France, 60200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nancy Cedex, France, 54042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BIARRITZ, France, 64200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bordeaux, France, 33000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Maisons lafitte, France, 78600 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site SAINT GERMAIN EN LAYE, France, 78100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Paris, France, 75018 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pantin, France, 93500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MONTARGIS, France, 45200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guadalajara, Spain, 19002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Salt, Spain, 17190 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pontevedra, Spain, 36002 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago de Compostela, Spain, 15701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Fernando, Spain, 11100 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Bleeding pattern and cycle controlTimeframe: 13 cycles
- Number of pregnanciesTimeframe: 13 cycles
Secondary Outcome
- Adverse events collectionTimeframe: 13 cycles
- Endometrial biopsyTimeframe: 13 cycles
- Physical and gynecological examTimeframe: 13 cycles
Additional Information
Copyright © Bayer
Powered by
