Contraception
Conditions
Brief 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
Interventions
DRUGCDB-2914 (ulipristal acetate)
single oral dose of 30 mg
DRUGPlacebo
single oral dose
Sponsors
HRA Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inhibition of follicular rupture | within 6 days after treatment intake | Inhibition is calculated as the number of subjects exhibiting no dominant follicle rupture, divided by the total number of subjects having received treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — | — |
| Appearance or absence of a corpus luteum | during the 6 days following treatment intake | — |
| Incidence of adverse events and occurrence of abnormal laboratory safety variables in comparison with baseline | — | — |
| Incidence of ovarian cysts after CDB-2914 treatment | — | — |
| Incidence of intermenstrual bleeding and treatment-emergent adverse events | — | — |
Countries
Chile, Dominican Republic
Outcome results
None listed