A prospective, randomized, double-blind parallel-arm, placebo-controlled study to assess the effects on ovarian activity of a combined oral contraceptive pill when preceded by the intake of ellaOne® (ulipristal acetate 30 mg) or placebo.
Phase 4
Completed
- Conditions
- contraceptionfertility control
- Registration Number
- NL-OMON37370
- Lead Sponsor
- HRA Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
- healthy women
- age 18-35 years
- not at risk for pregnancy
Exclusion Criteria
- contraindication for use of combined oral contraceptives (e.g. history of venous or arterial thromboembolic disease
- clinically relevant findings (physical and gynecological examination, blood pressure)
- irregular mentrual cycle
- intake of medication thought to interact with ellaOne or combined oral contraceptives
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- transvaginal ultrasound results, i.e. the mean diameter iin two axes of the<br /><br>largest follicle in each ovary and anteroposterior endometrial thickness<br /><br>- progesterone levels in serum<br /><br>- estradiol levels in serum</p><br>
- Secondary Outcome Measures
Name Time Method <p>- vaginal bleeding pattern<br /><br>- adverse events</p><br>