Trial Condition(s):
Contraception
A study to evaluate inhibition of ovulation of two oral estrogen/progestogen regimens in healthy, young females over a period of 3 treatment cycles
Bayer Identifier:
91697
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Bayer Pharma AG Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dinox GmbH Berlin Berlin, Germany, 10115 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- 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 noTimeframe: 12 months
Secondary Outcome
- Assessment of ovarian activity in treatment cycles 2 and 3Timeframe: 12 months
- Course of gonadotropins (FSH, LH)Timeframe: 12 months
- Endometrial growthTimeframe: 12 months
- Pharmacokinetics of estrogen and progestin in treatment cycle 3Timeframe: 12 months
Additional Information
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