The trial will be performed in healthy female volunteers. The intended indication is female contraception.
Conditions
Sponsors
Bayer Schering Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: • Assessment of ovarian activity in treatment cycles 2 and 3 • Course of gonadotropins (FSH, LH) • Endometrial growth • Pharmacokinetics of E1, E2 and DRSP in treatment cycle 3 ;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”. | — |
Countries
Germany
Outcome results
None listed