A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles
Phase 2
Completed
- Conditions
- Contraception
- Interventions
- Drug: BAY86-4891 (Estradiol / Drospirenone)
- Registration Number
- NCT00631124
- Lead Sponsor
- Bayer
- Brief Summary
Investigation of a new pill containing an estrogen and a progestin in order to monitor the inhibition of the ovulation in young healthy females over 3 treatment cycles
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 103
Inclusion Criteria
- Healthy female volunteers,
- Age 18 - 35 years
Exclusion Criteria
- Contraindications for use of a combined (estrogen/progestogen) contraceptive (e.g. history of venous/arterial thromboembolic disease)
- Regular intake of medication
- Clinically relevant findings (ECG, blood pressure, physical, gynecological examination, laboratory examination)
- Anovulatory pre-treatment cycle
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 BAY86-4891 (Estradiol / Drospirenone) - Arm 1 BAY86-4891 (Estradiol / Drospirenone) -
- Primary Outcome Measures
Name Time Method The primary efficacy variable will be the proportion of volunteers with ovulation in at least one of the treatment cycles 2 and 3, based on the binary variable ovulation (i.e. Hoogland score 6) with the levels yes and no 12 months
- Secondary Outcome Measures
Name Time Method Assessment of ovarian activity in treatment cycles 2 and 3 12 months Endometrial growth 12 months Pharmacokinetics of estrogen and progestin in treatment cycle 3 12 months Course of gonadotropins (FSH, LH) 12 months