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

HRA Pharma35 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Contraception

Interventions

CDB-2914 (ulipristal acetate)DRUG

single oral dose of 30 mg

PlaceboDRUG

single oral dose

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

ICMER

Santiago, Chile

Clinica de PROFAMILIA

Santo Domingo, Dominican Republic

Outcomes

Primary Outcomes

Inhibition of follicular rupture

Inhibition is calculated as the number of subjects exhibiting no dominant follicle rupture, divided by the total number of subjects having received treatment

Time frame: within 6 days after treatment intake

Secondary Outcomes

Appearance or absence of a corpus luteum

Time frame: during the 6 days following treatment intake

Growth pattern of leading follicle

number of cycles exhibiting atresia (diameter decrease ≥25%), or continued growth (diameter increase ≥25%), or interrupted growth (size remains within ±25% of the follicle size at the time of treatment)

Presence or absence of a surge of serum luteinizing hormone (LH) levels

The onset of an LH surge is defined as the occurrence of the first single serum LH value whose level is at least 50% higher than the mean of the last two previous measurements, or higher than the last previous measurement if only one previous LH level is available.

Menstrual cycle length in comparison to the subject's reported baseline average cycle length and to her placebo-treated cycle length

Incidence of intermenstrual bleeding and treatment-emergent adverse events

Incidence of adverse events and occurrence of abnormal laboratory safety variables in comparison with baseline

Incidence of ovarian cysts after CDB-2914 treatment

Data from ClinicalTrials.gov

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