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Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

This study has been terminated.
(Repros decided to stop the study because of safety and the FDA decided to put the study on hold because of safety.)
Sponsor:
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00683917
First received: May 22, 2008
Last updated: February 10, 2010
Last verified: February 2010
History of Changes
  Purpose

The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.


Condition Intervention Phase
Uterine Fibroids
 Drug: Proellex 25 mg
Drug: Proellex 50 mg
Drug: Lupron Depot
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Multi-center, Active Controlled, Pharmacokinetic, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids to Assess Persistence of Response

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • The primary outcome measure is the PK characteristics of 25 mg and 50 mg Proellex. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Transformed UFS-QoL severity score, uterine fibroid size as measured by MRI, relapse of symptoms as recorded on subject diary cards, and persistence of effect as measured by UFS-QoL. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: May 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Proellex 25 mg
 Drug: Proellex 25 mg
Proellex 25 mg, 1 capsule daily for 4 months
Experimental: B
Proellex 50 mg
 Drug: Proellex 50 mg
Proellex 50 mg, 2 capsules daily for 4 months
Active Comparator: C
Lupron Depot
 Drug: Lupron Depot
Lupron 3.75 mg monthly intramuscular injections for 4 months

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive
  • Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study
  • Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding
  • Regular or steady menstrual cycle lasting from 24 to 36 days
  • Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits
  • Subject must agree to use a medically acceptable and effective non-hormonal, double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug

Exclusion Criteria:

  • Documented endometriosis or active pelvic inflammatory disease
  • History of alcohol and/or drug abuse
  • Any history or diagnosis of gynecological cancer or cervical dysplasia
  • Use of an IUD

  • Use of prohibited concomitant medications:

    • Use of Depo-Provera must cease 10 months prior to first dose of study drug
    • Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of study drug and Lupton® Depot 8 months prior to the first visit
  • Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00683917

Locations
United States, Florida
Physician Care Clinical Research
Sarasota, Florida, United States, 34239
United States, Texas
West Houston Clinical Research Services
Houston, Texas, United States, 77055
Advances in Health, Inc.
Houston, Texas, United States, 77030
Mexico
Centro de Estudios Cientificos y Clinicos Pharma, S.A. de C.V. (CECYC-Pharma)
Mexico City, Federal District, Mexico, 03100
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: NCT00683917     History of Changes
Other Study ID Numbers: ZPU-202
Study First Received: May 22, 2008
Last Updated: February 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Uterine fibroids
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
Leuprolide
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013