Comparison of CDB-2914 Versus Placebo in the Prevention of Follicular Rupture Post-luteinizing Hormone (LH) Surge

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Evaluation of the effect of a single dose of CDB-2914, as compared to placebo, administered after the onset of the LH surge on the outcome of the leading ovary follicle:

• echographic follicle rupture

• inhibition of follicle rupture

• luteal phase progesterone levels

• anovulatory progesterone levels

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: HRA Pharma
• Treatments: Ulipristal acetate

Criteria

Inclusion Criteria:

• Women of good general health aged 18 - 35 years

• Not at risk of pregnancy

• Regular menstrual cycles of 24-35 days duration

• Not pregnant

• Intact uterus and ovaries

• Haemoglobin ≥ 11 g/dl

• Normal laboratory tests and normal TSH

• Willing to abstain from any use of hormonal contraception until study completion

• No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since termination of previous hormonal contraception

• Had at least one complete menstrual cycle (2 menses) following delivery, miscarriage or induced abortion

• Able to give voluntary, written informed consent, and agreeing to observe all study requirements for 5 complete menstrual cycles

Exclusion Criteria:

• Current participation in any other trial of an investigational medicine

• Known hypersensitivity to the ingredients of the test active substances or excipients

• Suspected hyperplasia or carcinoma of the endometrium

• Current pregnancy as confirmed by positive serum beta-hCG at screening

• Desire to get pregnant before the planned end of the study participation

• Currently breastfeeding

• Abnormal Pap smear

• Cancer (past history of any carcinoma or sarcoma)

• Known or suspected alcoholism or drug abuse

• Abnormal thyroid status

• Body mass index > 32

• Current use of hormonal contraception

• Use of hormonal emergency contraception since last menstrual period

• Severe asthma insufficiently controlled by oral glucocorticoids

• Hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption