Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914

PHASE2CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

February 28, 2006

Primary Completion Date

July 31, 2009

Study Completion Date

August 31, 2010

Conditions
Leiomyoma
Interventions
DRUG

ulipristal acetate 20 mg

ulipristal acetate at a daily dose of 20 mg, given once daily for three menstrual cycles or 90 - 102 days if amenorrheic

DRUG

ulipristal acetate 10 mg

10 mg given daily for three menstrual cycles or 90 - 102 days

DRUG

placebo

placebo given once daily for 3 menstrual cycles or 90 - 102 days

Trial Locations (2)

20891

NIH Clinical Center, Bethesda

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

HRA Pharma

INDUSTRY

lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH