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Dose-Response Study of VA2914 for Contraception
NCT00456924Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2004
- Countries
- 2
- Sponsor
- HRA Pharma
- Modality
- Small Molecules
- Drugs
- ulipristal
- Conditions
- contraception
01
Overview
Phase 2, randomised, double-blind trial of ulipristal in contraception (4 arms), sponsored by HRA Pharma. Primary endpoints: Serum levels of ovarian hormones (FSH, LH, Estradiol, Progesterone) at Day 84, Follicular development assessed by ultrasound at Day 77 and 1 more. Started Jan 2004; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo daily
VA2914 2.5 mg
VA2914 2.5 mg daily
VA2914 5 mg
VA2914 5 mg daily
VA2914 10 mg
VA2914 10 mg daily
03
Who it enrols
Healthy women aged 18-35 with regular ovulatory cycles, not pregnant, and using barrier contraception. Excludes those with BMI <16 or >28, smokers (>10/day), or those using hormonal treatments.
04
Endpoints
Primary
Serum levels of ovarian hormones (FSH, LH, Estradiol, Progesterone)
Follicular development assessed by ultrasound
Endometrial histology
Secondary
Menstrual bleeding patterns
Cervical mucus quality
Plasma concentration of VA2914
Adverse events
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