Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids

This study has been terminated.
(Repros decided to stop study because of safety and FDA decided to put study on hold.)
Sponsor:
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00737282
First received: August 14, 2008
Last updated: February 10, 2010
Last verified: February 2010
  Purpose

The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.


Condition Intervention Phase
Uterine Fibroids
Drug: Proellex® 25 mg
Drug: Proellex® 50 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 And 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • To assess the safety of Proellex administered once daily for three treatment cycles (4 months each cycle) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids [ Time Frame: 12 ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Proellex® 25 mg
Drug: Proellex® 25 mg
One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
Active Comparator: 2
Proellex® 50 mg
Drug: Proellex® 50 mg
Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

Detailed Description:

Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.

  Eligibility

Ages Eligible for Study:   18 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Speak, read and understand English or Spanish;
  • Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
  • One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
  • Menstrual cycle lasting from 24 to 36 days;
  • History of excessive menstrual bleeding;
  • Negative urine pregnancy test at screening.

Additional inclusion criteria may apply.

Exclusion Criteria:

  • Six months or more (immediately prior to Screening Visit) without a menstrual period;
  • Prior hysterectomy;
  • Prior bilateral oophorectomy;
  • Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
  • Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
  • Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
  • Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
  • Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.

Additional exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737282

  Show 25 Study Locations
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Study Director: Andre vanAs, MD, PhD Repros Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Andre vanAs, MD, PhD, Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00737282     History of Changes
Other Study ID Numbers: ZPU-305
Study First Received: August 14, 2008
Last Updated: February 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Uterine Fibroids

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on April 17, 2014