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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| CDB-2914 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDB-2914 (ulipristal acetate) | Drug | single oral dose of 30 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Appearance or absence of a corpus luteum | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICMER | Santiago | Chile | ||||
| Clinica de PROFAMILIA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20634186 | Result | 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/deq157. Epub 2010 Jul 15. |
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| ID | Term |
|---|---|
| C094854 | ulipristal |
| C555622 | ulipristal acetate |
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| Placebo |
| Drug |
single oral dose |
|
| 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 |
| Santo Domingo |
| Dominican Republic |