Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids

This study has been terminated.
(Repros stopped study due to safety and FDA placed study on hold)
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01069120
First received: February 10, 2010
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.


Condition Intervention Phase
Uterine Fibroids
Drug: Proellex
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 Multicenter Extension Study Evaluating the Safety of 25 and 50 mg Proellex® in the Treatment of Women Who Have Completed ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • To assess the incidence of adverse events (AE) and serious adverse events (SAEs) [ Time Frame: During two 4 month treatment periods ] [ Designated as safety issue: Yes ]
  • To assess change from baseline of endometrial histology and thickness, laboratory and endocrinology assessments, vital signs and electrocardiogram for each treatment group and between treatments [ Time Frame: During two 4 month treatment periods ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess change from baseline of BMD for spine, femoral neck and total hip, as noted by changes in DEXA scan in normal and osteopenic groups for each treatment group and between treatments. [ Time Frame: During two 4 month treatment periods ] [ Designated as safety issue: Yes ]

Enrollment: 27
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 50 mg Proellex®
2, 25 mg capsules
Drug: Proellex
2, 25 mg capsules once per day
Other Name: CDB-4124
Active Comparator: 25 mg Proellex®
1, 25 mg capsule
Drug: Proellex
1, 25 mg capsule once per day
Other Name: CDB-4124

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
  • Subject has a menstrual cycle lasting from 20 to 40 days.
  • Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Exclusion Criteria:

  • Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.
  • Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01069120

Locations
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33472
Insignia Clinical Research (Tampa Bay Women's Center)
Tampa, Florida, United States, 33067
United States, Texas
The Women's Hospital of Texas, Clinical Research Center
Houston, Texas, United States, 77054
Advances in Health Inc
Houston, Texas, United States, 77030
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Study Director: Andre vanAS, PhD, Md Repros Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01069120     History of Changes
Other Study ID Numbers: ZPU-307
Study First Received: February 10, 2010
Last Updated: June 23, 2014
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 July 26, 2014