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FC Patch Low: Metabolism Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00933179
First Posted: July 7, 2009
Last Update Posted: November 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
July 3, 2009
July 7, 2009
November 14, 2014
June 2009
September 2010   (Final data collection date for primary outcome measure)
Prothrombin fragment 1+2, D-dimer [ Time Frame: Screening, visit 3-7 ]
Same as current
Complete list of historical versions of study NCT00933179 on ClinicalTrials.gov Archive Site
  • Procoagulatory parameters [ Time Frame: Screening, visit 3-7 ]
  • Anticoagulatory parameters [ Time Frame: Screening, visit 3-7 ]
  • Thrombin and Fibrin turnover parameters [ Time Frame: Screening, visit 3-7 ]
Same as current
Not Provided
Not Provided
 
FC Patch Low: Metabolism Study
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Contraception
  • Drug: Gestodene/EE Patch (BAY86-5016)
    21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 3 cycles
  • Drug: EE/Levonorgestrel (Microgynon, BAY86-4977)
    21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 3 cycles
  • Experimental: Arm 1
    Intervention: Drug: Gestodene/EE Patch (BAY86-5016)
  • Active Comparator: Arm 2
    Intervention: Drug: EE/Levonorgestrel (Microgynon, BAY86-4977)
Junge W, Heger-Mahn D, Trummer D, Merz M. Investigation of the hemostatic effect of a transdermal patch containing 0.55 mg ethinyl estradiol and 2.1 mg gestodene compared with a monophasic oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel: an open-label, randomized, crossover study. Drugs R D. 2013 Sep;13(3):223-33. doi: 10.1007/s40268-013-0028-2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2010
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00933179
91557
2008-007024-26 ( EudraCT Number )
Yes
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP