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

Primary Purpose

Uterine Fibroids

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Proellex 25 mg

Proellex 50 mg

Lupron Depot

About this trial

This is an interventional prevention trial for Uterine Fibroids focused on measuring Uterine fibroids, Fibroids

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Physician Care Clinical Research
Advances in Health, Inc.
West Houston Clinical Research Services
Centro de Estudios Cientificos y Clinicos Pharma, S.A. de C.V. (CECYC-Pharma)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Proellex 25 mg

Proellex 50 mg

Lupron

Arm Description

Proellex 25 mg

Proellex 50 mg

Lupron Depot

Outcomes

Primary Outcome Measures

The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.

Secondary Outcome Measures

Full Information

NCT ID

NCT00683917

First Posted

May 22, 2008

Last Updated

August 5, 2014

Sponsor

Repros Therapeutics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00683917

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Terminated

Why Stopped

Repros stopped the study for safety and FDA put the study on hold for safety.

Study Start Date

May 2008 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Repros Therapeutics Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Fibroids

Keywords

Uterine fibroids, Fibroids

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Proellex 25 mg

Arm Type

Experimental

Arm Description

Proellex 25 mg

Arm Title

Proellex 50 mg

Arm Type

Experimental

Arm Description

Proellex 50 mg

Arm Title

Lupron

Arm Type

Active Comparator

Arm Description

Lupron Depot

Intervention Type

Drug

Intervention Name(s)

Proellex 25 mg

Other Intervention Name(s)

Telapristone acetate

Intervention Description

Proellex 25 mg, 1 capsule daily for 4 months

Intervention Type

Drug

Intervention Name(s)

Proellex 50 mg

Other Intervention Name(s)

Telapristone acetate

Intervention Description

Proellex 50 mg, 2 capsules daily for 4 months

Intervention Type

Drug

Intervention Name(s)

Lupron Depot

Other Intervention Name(s)

Leuprolide acetate

Intervention Description

Lupron 3.75 mg monthly intramuscular injections for 4 months

Primary Outcome Measure Information:

Title

The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.

Time Frame

4 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andre vanAs, MD, PhD

Organizational Affiliation

Repros Therapeutics Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Physician Care Clinical Research

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Advances in Health, Inc.

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

West Houston Clinical Research Services

City

Houston

State/Province

Texas

ZIP/Postal Code

77055

Country

United States

Facility Name

Centro de Estudios Cientificos y Clinicos Pharma, S.A. de C.V. (CECYC-Pharma)

City

Mexico City

State/Province

Federal District

ZIP/Postal Code

03100

Country

Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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