Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00882258
First received: April 14, 2009
Last updated: July 3, 2014
Last verified: July 2014

April 14, 2009
July 3, 2014
March 2006
March 2007   (final data collection date for primary outcome measure)
To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata [ Time Frame: 91 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00882258 on ClinicalTrials.gov Archive Site
To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata [ Time Frame: 91 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
A Phase II, Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Uterine Fibroids
  • Drug: 12.5 mg Proellex
    12.5 mg Proellex administered orally daily
    Other Names:
    • CDB-4124
    • Telapristone acetate
  • Drug: 25 mg Proellex
    25 mg Proellex administered orally daily
    Other Names:
    • CDB-4124
    • Telapristone acetate
  • Drug: Placebo
    Administered orally daily
    Other Name: Dummy
  • Experimental: 12.5 mg Proellex
    Proellex 12.5 mg daily
    Intervention: Drug: 12.5 mg Proellex
  • Experimental: 25 mg Proellex daily
    Proellex 25 mg
    Intervention: Drug: 25 mg Proellex
  • Placebo Comparator: Placebo
    Placebo daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least one leiomyoma must have been identifiable and measurable by abdominal/pelvic ultrasound.
  • Must have had a history of one or both of the following leiomyomata-associated symptoms, excessive menstrual bleeding, or pain

Exclusion Criteria:

  • Post-menopausal women, as defined as one or more of the following:

    1. six months or more (immediately prior to Screening visit) without a menstrual period, or
    2. prior hysterectomy and/or oophorectomy
  • Subjects with documented endometriosis
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00882258
ZPU-003
Yes
Repros Therapeutics Inc.
Repros Therapeutics Inc.
Not Provided
Study Director: Andre VanAs, PhD, MD Repros Therapeutics Inc.
Repros Therapeutics Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP