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

HRA Pharma

Status and phase: Completed; Phase 2

Conditions: Contraception

Treatments: Drug: Placebo; Drug: CDB-2914 (ulipristal acetate)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01107093

2914-007

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

35 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

CDB-2914

Active Comparator group

Treatment:

Drug: CDB-2914 (ulipristal acetate)