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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00874302
Recruitment Status : Withdrawn (Study terminated for safety and the FDA put the study on hold for safety.)
First Posted : April 2, 2009
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Uterine Fibroids Drug: Proellex Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles [ Time Frame: Four months each cycle ]

Secondary Outcome Measures :
  1. To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids [ Time Frame: Two, 4 month cycles ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874302


Locations
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Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
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Study Director: Andre van As, MD, PhD Repros Therapeutics Inc.

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Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00874302    
Other Study ID Numbers: ZPU-306
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: June 27, 2014
Last Verified: June 2014
Keywords provided by Repros Therapeutics Inc.:
Uterine fibroids
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Recurrence
Disease Attributes
Pathologic Processes
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases