A single-center, randomized, open-label, two-arm study to evaluate the ovarian function inhibition of a monophasic combined oral contraceptive (COC) containing 15 mg estetrol (E4) and 3 mg drospirenone (DRSP) and a monophasic COC containing 20 mcg ethinylestradiol (E4)/3 mg drospirenone (Yaz®), administered orally once daily in a 24/4 day regimen for three consecutive cycles
Phase 2
Completed
- Conditions
- contraceptionbirth control
- Registration Number
- NL-OMON43032
- Lead Sponsor
- Estetra SPR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
All inclusion criteria defined in the study protocol (section 3.3.1) must be met for a subject to be eligible for inclusion in the study
Exclusion Criteria
A subject who meets any of the exclusion criteria defined in the study protocol (section 3.3.2) will not be eligible for inclusion in the study:
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Ovarian suppression as assessed with the Hoogland score at Treatment Cycle 1<br /><br>and Treatment Cycle 3 based on:<br /><br><br /><br>* follicular size assessed by TVUS<br /><br>* endogenous hormone levels: serum E2, and serum progesterone<br /><br><br /><br>In case of suspicion of ovulation, additional progesterone measurement will be<br /><br>scheduled on Cycle Day 2, 4 and 6 after suspected ovulation</p><br>
- Secondary Outcome Measures
Name Time Method