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FC Patch Low: Metabolism Study

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00933179
First received: July 3, 2009
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Prothrombin fragment 1+2, D-dimer [ Time Frame: Screening, visit 3-7 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Procoagulatory parameters [ Time Frame: Screening, visit 3-7 ] [ Designated as safety issue: Yes ]
  • Anticoagulatory parameters [ Time Frame: Screening, visit 3-7 ] [ Designated as safety issue: Yes ]
  • Thrombin and Fibrin turnover parameters [ Time Frame: Screening, visit 3-7 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933179

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00933179     History of Changes
Other Study ID Numbers: 91557, 2008-007024-26
Study First Received: July 3, 2009
Last Updated: April 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Prevention of pregnancy

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

ClinicalTrials.gov processed this record on May 21, 2013