Contraception Clinical Trial
Official title:
A Prospective, Randomized, Double-blind, Cross-Over Study to Compare the Capacity to Prevent Follicular Rupture of CDB-2914 With Placebo, When Administered After the Ovulatory Process Has Been Triggered by the LH Surge
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
Status | Completed |
Enrollment | 35 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind
Country | Name | City | State |
---|---|---|---|
Chile | ICMER | Santiago | |
Dominican Republic | Clinica de PROFAMILIA | Santo Domingo |
Lead Sponsor | Collaborator |
---|---|
HRA Pharma |
Chile, Dominican Republic,
Brache V, Cochon L, Jesam C, Maldonado R, Salvatierra AM, Levy DP, Gainer E, Croxatto HB. Immediate pre-ovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. Hum Reprod. 2010 Sep;25(9):2256-63. doi: 10.1093/humrep/d — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | within 6 days after treatment intake | No |
Secondary | Appearance or absence of a corpus luteum | during the 6 days following treatment intake | No | |
Secondary | 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) | No | |
Secondary | 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. | No | |
Secondary | Menstrual cycle length in comparison to the subject's reported baseline average cycle length and to her placebo-treated cycle length | Yes | ||
Secondary | Incidence of intermenstrual bleeding and treatment-emergent adverse events | Yes | ||
Secondary | Incidence of adverse events and occurrence of abnormal laboratory safety variables in comparison with baseline | Yes | ||
Secondary | Incidence of ovarian cysts after CDB-2914 treatment | Yes |
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