Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms

This study has been withdrawn prior to enrollment.
(Study terminated for safety and the FDA put the study on hold for safety.)
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00874302
First received: March 31, 2009
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.


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, Open Label, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex to Assess Recurrence of Symptoms in the Treatment of Symptomatic Uterine Fibroids

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles [ Time Frame: Four months each cycle ] [ 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: Two, 4 month cycles ] [ Designated as safety issue: Yes ]

Enrollment: 0
Arms Assigned Interventions
Experimental: 25 mg
25 mg Proellex
Drug: Proellex
One 25mg capsule taken orally once every day.
Other Name: Telapristone acetate
Experimental: 50 mg
50 mg Proellex
Drug: Proellex
Two 25mg capsules Proellex (50mg) taken orally once every day
Other Name: Telapristone acetate

Detailed Description:

Subjects with documented symptomatic uterine fibroids will be enrolled in the study. Following screening, subjects will receive daily oral study medication and will be assessed monthly for a 4 month treatment cycle. This first cycle will be followed by an off-drug interval until there is a return of significant symptomatology. Subjects will be followed for up to six (6) months post-treatment. If their lack of symptoms does not qualify them for a second cycle of treatment, they will be discharged from the study. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least one uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
  • Subject must have uterine fibroid-associated symptoms during the-screening visit
  • Subject has menstrual cycle lasting from 20 to 40 days
  • Other inclusion criteria may apply

Exclusion Criteria:

  • Post-menopausal women or women likely to become post-menopausal during the study
  • Subject with a significant organ abnormality or disease (based on the Investigator's judgment) that would in the opinion of the Investigator exclude the subject from participating
  • Subject with any medical condition that, in the opinion of the Investigator, is not compatible with study procedures or which would prevent the subject from starting or completing the study, or interfere with the subject participating in this study.
  • Subject who has had an acute illness within five days of study medication administration
  • Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically
  • Subject with an abnormal screening endometrial biopsy including the presence of Endometrial Intraepithelial Neoplasia (EIN)
  • Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at screening
  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: NCT00874302

Locations
United States, California
Genesis Center for Clinical Research
San Diego, California, United States, 92103
United States, Florida
Physician Care Clinical Research, LLC
Sarasota, Florida, United States, 34239
United States, Georgia
Atlanta Women's Research Inst.
Atlanta, Georgia, United States, 30342
Soapstone Center for Clinical Research
Decatur, Georgia, United States, 30034
United States, Louisiana
York Clinical Consulting
Marrero, Louisiana, United States, 70072
United States, Michigan
Female Pelvic Medicine
Grand Rapids, Michigan, United States, 49503
United States, North Carolina
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, United States, 27103
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States, 27103
United States, Oregon
Clinical Trials of America
Eugene, Oregon, United States, 97408
United States, Pennsylvania
Thomas Jefferson University - Jefferson Center for Women's Medical Specialties
Philadelphia, Pennsylvania, United States, 19107-5127
United States, Tennessee
Women's Care Center, PLC Research Memphis Associates
Memphis, Tennessee, United States, 38119
Meharry Medical College
Nashville, Tennessee, United States, 37208
United States, Texas
Willowbend Health & Wellness Associates
Plano, Texas, United States, 75093
Brazil
Cepeme/Cerfahc
Curitiba, Paraná., Brazil, 80030-220
Vox Femina
Jundiaí, Brazil, 13209-000
Hospital Santa Marcelina
São Paulo, Brazil, 08270-070
Brazilmed
São Paulo, Brazil, 01416-000
Hospital dos Servidores Públicos de SP
São Paulo, Brazil, 04039-901
Hospital Heliópolis
São Paulo, Brazil, 04230 - 000
Universidade Federal de São Paulo - UNIFESP
São Paulo, Brazil, 04015-001
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Study Director: Andre van As, MD, PhD Repros Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00874302     History of Changes
Other Study ID Numbers: ZPU-306
Study First Received: March 31, 2009
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Uterine fibroids

Additional relevant MeSH terms:
Recurrence
Leiomyoma
Myofibroma
Disease Attributes
Pathologic Processes
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 September 18, 2014