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

August 5, 2014 updated by: Repros Therapeutics Inc.

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

PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Federal District
      • Mexico City, Federal District, Mexico, 03100
        • Centro de Estudios Cientificos y Clinicos Pharma, S.A. de C.V. (CECYC-Pharma)
  • United States
    • Florida
      • Sarasota, Florida, United States, 34239
        • Physician Care Clinical Research
    • Texas
      • Houston, Texas, United States, 77055
        • West Houston Clinical Research Services
      • Houston, Texas, United States, 77030
        • Advances In Health, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proellex 25 mg
Drug: Proellex 25 mg
Proellex 25 mg, 1 capsule daily for 4 months
Other Names:
  • Telapristone acetate
Experimental: Proellex 50 mg
Drug: Proellex 50 mg
Proellex 50 mg, 2 capsules daily for 4 months
Other Names:
  • Telapristone acetate
Active Comparator: Lupron
Lupron Depot
Drug: Lupron Depot
Lupron 3.75 mg monthly intramuscular injections for 4 months
Other Names:
  • Leuprolide acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Repros Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

May 22, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 26, 2008

Study Record Updates

Last Update Posted (Estimate)

August 21, 2014

Last Update Submitted That Met QC Criteria

August 5, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZPU-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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