A double-blind, randomized, uncontrolled study to evaluate inhibition of ovulation of two oral estradiol / drospirenone regimens in healthy young female volunteers over a period of 3 treatment cycles
- Conditions
- The trial will be performed in healthy female volunteers. The intended indication is female contraception.
- Registration Number
- EUCTR2007-004544-73-DE
- Lead Sponsor
- Bayer Schering Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Healthy female volunteer
Age: 18 – 35 years (inclusive) at the first screening examination
Willingness to use non-hormonal methods of contraception during the entire study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to evaluate the inhibition of ovulation in treatment cycles 2 and 3 after administration of two different (one mono- and one triphasic) 24-day regimens containing E2 and DRSP for 3 treatment cycles.;Secondary Objective: The following evaluations represent the secondary objectives:<br>•Assessment of ovarian activity in treatment cycles 2 and 3<br>•Course of gonadotropins (FSH, LH)<br>•Endometrial growth<br>•Pharmacokinetics of E1, E2 and DRSP in treatment cycle 3<br>;Primary end point(s): 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”.
- Secondary Outcome Measures
Name Time Method