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

Uterine Fibroids Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882258
• Other study ID #: ZPU-003
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2009
• Last updated: July 3, 2014
• Start date: March 2006
• Est. completion date: March 2007

Study information

• Verified date: July 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• 12.5 mg Proellex
12.5 mg Proellex administered orally daily
• 25 mg Proellex
25 mg Proellex administered orally daily
• Placebo
Administered orally daily

Locations

Country	Name	City	State
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Visions Clinical Research	Boynton Beach	Florida
United States	SC Clinical Research Center	Columbia	South Carolina
United States	Downtown Women's Health Care	Denver	Colorado
United States	Advances in Health Inc.	Houston	Texas
United States	Obstetrical & Gynecolgical Associates, PA (OGA)	Houston	Texas
United States	Affiliated Clinical Research, Inc.	Las Vegas	Nevada
United States	Caring for Women	Las Vegas	Nevada
United States	Miami Research Associates, Women's Health Studies	Miami	Florida
United States	Arizona Wellness Centre for Women	Phoenix	Arizona
United States	Women's Health Research	Phoenix	Arizona
United States	Medical Centre for Clinical Research	San Diego	California
United States	Women's Health Care, Inc.	San Diego	California
United States	Women's Clinical Research Centre	Seattle	Washington
United States	Insignia Clinical Research (Tampa Bay Women's Center)	Tampa	Florida
United States	Visions Clinical Research Tuscon	Tuscon	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata		91 days	Yes
Secondary	To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata		91 days	No