A Phase 2 interventional study of CDB-2914 (ulipristal acetate) and Placebo in Contraception, sponsored by HRA Pharma. Completed at 2 sites in 2 countries. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-25.
Sponsored by HRA Pharma · Phase 2 and Interventional
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:
557 studies on the registry are indexed under Rupture; 97 are open to participants now.
This study's enrollment of 35 is below the median of 72 across 334 interventional studies indexed under Rupture.
Browse Rupture studies →HRA Pharma is the lead sponsor of 14 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo
Drug: CDB-2914 (ulipristal acetate)
single oral dose of 30 mg
single oral dose
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
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
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
HRA Pharma