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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single oral dose

CDB-2914

Group Type ACTIVE_COMPARATOR

CDB-2914 (ulipristal acetate)

Intervention Type DRUG

single oral dose of 30 mg

Interventions

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CDB-2914 (ulipristal acetate)

single oral dose of 30 mg

Intervention Type DRUG

Placebo

single oral dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes