FC Patch Low: Metabolism Study

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933179
• Other study ID #: 91557
• Secondary ID: 2008-007024-26
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2009
• Last updated: November 13, 2014
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 m — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prothrombin fragment 1+2, D-dimer		Screening, visit 3-7	Yes
Secondary	Procoagulatory parameters		Screening, visit 3-7	Yes
Secondary	Anticoagulatory parameters		Screening, visit 3-7	Yes
Secondary	Thrombin and Fibrin turnover parameters		Screening, visit 3-7	Yes

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