FC Patch Low: Metabolism Study

Bayer

Status and phase: Completed; Phase 2

Conditions: Contraception

Treatments: Drug: Gestodene/EE Patch (BAY86-5016); Drug: EE/Levonorgestrel (Microgynon, BAY86-4977)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00933179

2008-007024-26 (EudraCT Number)

91557

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: Gestodene/EE Patch (BAY86-5016)

Arm 2

Active Comparator group

Treatment:

Drug: EE/Levonorgestrel (Microgynon, BAY86-4977)