At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 72 enrolled
Drug / intervention
ulipristal acetate 20 mg +2 moredrug
Likely dose
ulipristal acetate 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Whether the Selective Progesterone Receptor Modulator CDB-2914 Can Shrink Leiomyomata
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Feb 10, 2006·Updated Jul 15, 2024
In Brief
A Phase 2 clinical trial evaluating ulipristal acetate 20 mg, ulipristal acetate 10 mg, and 1 other intervention for Leiomyoma. Completed, enrolled 72 participants across 2 sites.
Detailed Summary
This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeiomyoma
CountriesUnited States
CollaboratorsHRA Pharma
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedFeb 2006
Primary CompletionJul 2009
Study CompletionAug 2010
TodayJul 2026
First PostedFeb 10, 2006
Enrollment StartFeb 1, 2006
Primary CompletionJul 1, 2009
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.4 years ago
Interventions
ulipristal acetate 20 mgdrug
ulipristal acetate at a daily dose of 20 mg, given once daily for three menstrual cycles or 90 - 102 days if amenorrheic
ulipristal acetate 10 mgdrug
10 mg given daily for three menstrual cycles or 90 - 102 days
placebodrug
placebo given once daily for 3 menstrual cycles or 90 - 102 days