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A Phase 2, Study to Evaluate the Safety and Efficacy Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Uterine Fibroids

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ClinicalTrials.gov Identifier: NCT02323646
Recruitment Status : Completed
First Posted : December 23, 2014
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Study Description
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Brief Summary:
The primary objective of this study is to determine the safety and efficacy of two vaginal doses of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Drug: Placebo Comparator Drug: Proellex 6 mg Drug: Proellex 12 mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Study Start Date : December 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo Comparator
Safety and efficacy comparison of 6 mg and 12 mg for 2, 18 week courses of treatment for uterine fibroids
Other Name: Placebo
Experimental: 6 mg Proellex® (Telapristone Acetate)
6 mg Proellex® (Telapristone Acetate) vaginal suppository
 Drug: Proellex 6 mg
Safety and efficacy comparison of 6 mg and 12 mg for 2, 18 week courses of treatment for uterine fibroids
Other Name: Telapristone Acetate
Experimental: 12 mg Proellex® (Telapristone Acetate)
12 mg Proellex® (Telapristone Acetate) vaginal suppository
 Drug: Proellex 12 mg
Safety and efficacy comparison of 6 mg and 12 mg for 2, 18 week courses of treatment for uterine fibroids
Other Name: Telapristone Acetate


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of subjects who become amenorrheic after one course of treatment [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 47 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Otherwise healthy adult females between 18 and 47 years
  • Subject has a history of at least 3 regular menstrual cycles in which menorrhagia is due to uterine fibroids.
  • Subject must have uterine fibroids.
  • Agreement not to attempt to become pregnant during the trial
  • Agreement to use only sanitary pads provided throughout the course of the study, tampon use is prohibited
  • Ability to complete a daily subject diary and study procedures in compliance with the protocol
  • Has a negative pregnancy test at the Screening and Baseline visits, and subsequent study visits
  • A Body Mass Index (BMI) between 18 and 45 inclusive
  • Confirmed > 80 mL of menstrual blood loss caused by uterine fibroids

Exclusion Criteria:

  • Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy.
  • Subject is pregnant or lactating or is attempting or expecting to become pregnant during the entire study period
  • Received an investigational drug in the 30 days prior to the screening for this study
  • Subject has a history of PCOS
  • Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study
  • Use of oral contraceptives in the preceding 30 days. Use of Depo-Provera® in the preceding 10 months.
  • Use of GnRHas (e.g. Lupron Depot) within 3 months of the first dose of study drug (Lupron Depot must have a wash-out period of 3 months)
  • Has an IUD in place
  • Known or suspected carcinoma of the breast or reproductive organs
  • Recent history (within past 6 months) of alcoholism or drug abuse
  • Clinically significant abnormal findings on screening examination and laboratory assessments or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study
Contacts and Locations
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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): NCT02323646


Locations
United States, Florida
Fort Lauderdale, Florida, United States, 33316
United States, Georgia
Sandy Springs, Georgia, United States, 30328
United States, Louisiana
Metairie, Louisiana, United States, 70001
United States, Michigan
Saginaw, Michigan, United States, 48604
United States, North Carolina
Raleigh, North Carolina, United States, 27612
United States, Texas
Houston, Texas, United States, 77030
Houston, Texas, United States, 77054
United States, Virginia
Richmond, Virginia, United States, 23235-4759
Sponsors and Collaborators
Repros Therapeutics Inc.
More Information
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Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02323646     History of Changes
Other Study ID Numbers: ZPV-201
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: May 2018

Keywords provided by Repros Therapeutics Inc.:
uterine fibroids
leiomyoma
fibroid tumor
fibroma

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