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

Primary Purpose

Uterine Fibroids

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
12.5 mg Proellex
25 mg Proellex
Placebo
Sponsored by
Repros Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring Uterine fibroids

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Clinical Therapeutics, LLC
  • Women's Health Research
  • Arizona Wellness Centre for Women
  • Visions Clinical Research Tuscon
  • Medical Centre for Clinical Research
  • Women's Health Care, Inc.
  • Downtown Women's Health Care
  • Visions Clinical Research
  • Miami Research Associates, Women's Health Studies
  • Insignia Clinical Research (Tampa Bay Women's Center)
  • Caring for Women
  • Affiliated Clinical Research, Inc.
  • SC Clinical Research Center
  • Advances in Health Inc.
  • Obstetrical & Gynecolgical Associates, PA (OGA)
  • Women's Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

12.5 mg Proellex

25 mg Proellex daily

Placebo

Arm Description

Proellex 12.5 mg daily

Proellex 25 mg

Placebo daily

Outcomes

Primary Outcome Measures

To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata

Secondary Outcome Measures

To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata

Full Information

First Posted
April 14, 2009
Last Updated
July 3, 2014
Sponsor
Repros Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00882258
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Repros Therapeutics Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
Uterine fibroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
12.5 mg Proellex
Arm Type
Experimental
Arm Description
Proellex 12.5 mg daily
Arm Title
25 mg Proellex daily
Arm Type
Experimental
Arm Description
Proellex 25 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo daily
Intervention Type
Drug
Intervention Name(s)
12.5 mg Proellex
Other Intervention Name(s)
CDB-4124, Telapristone acetate
Intervention Description
12.5 mg Proellex administered orally daily
Intervention Type
Drug
Intervention Name(s)
25 mg Proellex
Other Intervention Name(s)
CDB-4124, Telapristone acetate
Intervention Description
25 mg Proellex administered orally daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Dummy
Intervention Description
Administered orally daily
Primary Outcome Measure Information:
Title
To evaluate Proellex administered once daily in pre-menopausal women with symptomatic leiomyomata
Time Frame
91 days
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of two different doses of Proellex versus placebo for the treatment of symptomatic leiomyomata
Time Frame
91 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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: six months or more (immediately prior to Screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy Subjects with documented endometriosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre VanAs, PhD, MD
Organizational Affiliation
Repros Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Clinical Therapeutics, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Women's Health Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Arizona Wellness Centre for Women
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Visions Clinical Research Tuscon
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Medical Centre for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Women's Health Care, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Downtown Women's Health Care
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Visions Clinical Research
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Miami Research Associates, Women's Health Studies
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Insignia Clinical Research (Tampa Bay Women's Center)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Caring for Women
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Affiliated Clinical Research, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
SC Clinical Research Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Advances in Health Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Obstetrical & Gynecolgical Associates, PA (OGA)
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Women's Clinical Research Centre
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

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

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