- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00933179
FC Patch Low: Metabolism Study
November 13, 2014 updated by: Bayer
A Single-Center, Open-Label, Crossover, Randomized Study to Investigate the Impact of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene (Material no. 80876395) in a 21-day Regimen as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (0.03mg/0.15mg) in a 21-day Regimen on Hemostatic Parameters in 30 Women Aged 18 182 35 Years Over 3 Treatment Cycles in Each Period
The aim of the present study is to investigate the effects of the transdermal patch on the parameters of hemostasis (blood clotting), lipid (fat), and carbohydrate (sugars) metabolism in healthy women who require contraception.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Berlin, Germany, 10115
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Healthy woman requesting contraception
- Normal cervical smear not requiring further follow-up
- History of regular cyclic menstrual periods
- Willingness to use non-hormonal contraception during the two wash-out cycles both before the start of treatment and between the two treatment periods
Exclusion Criteria:
- Pregnancy or lactation - Obesity (Body Mass Index [BMI] > 30.0 kg/m2)
- Any diseases or conditions that can compromise the function of the body systems
- Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
- Any disease or condition that may worsen under hormonal treatment
- Undiagnosed abnormal genital bleeding
- Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm 2
|
21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 3 cycles
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Experimental: Arm 1
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21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 3 cycles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prothrombin fragment 1+2, D-dimer
Time Frame: Screening, visit 3-7
|
Screening, visit 3-7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Procoagulatory parameters
Time Frame: Screening, visit 3-7
|
Screening, visit 3-7
|
Anticoagulatory parameters
Time Frame: Screening, visit 3-7
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Screening, visit 3-7
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Thrombin and Fibrin turnover parameters
Time Frame: Screening, visit 3-7
|
Screening, visit 3-7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
July 3, 2009
First Submitted That Met QC Criteria
July 3, 2009
First Posted (Estimate)
July 7, 2009
Study Record Updates
Last Update Posted (Estimate)
November 14, 2014
Last Update Submitted That Met QC Criteria
November 13, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Contraceptives, Postcoital, Synthetic
- Contraceptives, Postcoital
- Progestins
- Contraceptives, Postcoital, Hormonal
- Levonorgestrel
- Ethinyl estradiol, levonorgestrel drug combination
- Ethinyl Estradiol-Norgestrel Combination
- Gestodene
Other Study ID Numbers
- 91557
- 2008-007024-26 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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