Clinical trial NCT00882258: Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uterine Fibroids
Keywords: Uterine fibroids
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata
timeFrame: 91 days
Secondary outcomes:
measure: To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata
timeFrame: 91 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Wellness Centre for Women
state: Arizona
city: Tuscon
country: United States
facility: Visions Clinical Research Tuscon
state: Arizona
city: San Diego
country: United States
facility: Medical Centre for Clinical Research
state: California
city: San Diego
country: United States
facility: Women's Health Care, Inc.
state: California
city: Denver
country: United States
facility: Downtown Women's Health Care
state: Colorado
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Miami
country: United States
facility: Miami Research Associates, Women's Health Studies
state: Florida
city: Tampa
country: United States
facility: Insignia Clinical Research (Tampa Bay Women's Center)
state: Florida
city: Las Vegas
country: United States
facility: Caring for Women
state: Nevada
city: Las Vegas
country: United States
facility: Affiliated Clinical Research, Inc.
state: Nevada
city: Columbia
country: United States
facility: SC Clinical Research Center
state: South Carolina
city: Houston
country: United States
facility: Advances in Health Inc.
state: Texas
city: Houston
country: United States
facility: Obstetrical & Gynecolgical Associates, PA (OGA)
state: Texas
city: Seattle
country: United States
facility: Women's Clinical Research Centre
state: Washington
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre VanAs, PhD, MD
role: STUDY_DIRECTOR
References: