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OpenTrials
Completed

NCT Number: NCT00933179

FC Patch Low: Metabolism Study

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.

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Key information

Conditions

Contraception

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Berlin, State of Berlin, 10115, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gestodene/EE Patch (BAY86-5016)

Drug

21-day regimen per cycle (1 patch a week for 3 weeks followed by a 7-day patch-free period) for 3 cycles

EE/Levonorgestrel (Microgynon, BAY86-4977)

Drug

21-day regimen per cycle (1 tablet a day for 3 weeks followed by a 7-day tablet-free period) for 3 cycles

Primary outcomes

  1. Prothrombin fragment 1+2, D-dimer

    Time frame: Screening, visit 3-7

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 7, 2009
Registry last updated
Nov 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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