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FC Patch Low: Metabolism Study

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ClinicalTrials.gov Identifier: NCT00933179
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Gestodene/EE Patch (BAY86-5016) Drug: EE/Levonorgestrel (Microgynon, BAY86-4977) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : June 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 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
Active Comparator: Arm 2 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



Primary Outcome Measures :
  1. Prothrombin fragment 1+2, D-dimer [ Time Frame: Screening, visit 3-7 ]

Secondary Outcome Measures :
  1. Procoagulatory parameters [ Time Frame: Screening, visit 3-7 ]
  2. Anticoagulatory parameters [ Time Frame: Screening, visit 3-7 ]
  3. Thrombin and Fibrin turnover parameters [ Time Frame: Screening, visit 3-7 ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933179


Locations
Germany
Berlin, Germany, 10115
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications of Results:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00933179     History of Changes
Other Study ID Numbers: 91557
2008-007024-26 ( EudraCT Number )
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014

Keywords provided by Bayer:
Prevention of pregnancy

Additional relevant MeSH terms:
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Gestodene
Ethinyl Estradiol
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptives, Oral, Combined
Progestins