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Determination of the Lowest, Safe and Effective Dose of Proellex

Primary Purpose

Amenorrhea

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Proellex

About this trial

This is an interventional treatment trial for Amenorrhea focused on measuring Liver Function, Steady State Exposure

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Ability to understand and provide a written informed consent.
Healthy adult females between 18 and 50 years of age. Included in this group are women with the following conditions, not currently receiving drug treatment:
- Excessive menstrual bleeding;
- Menstrual pain;
- Confirmed uterine fibroids; and
- Confirmed endometriosis
Normal menstrual cycle of 26-32 days
Agree not to attempt to become pregnant
Agree to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours of each visit
Ability to swallow gelatin capsules Ability to complete a daily subject diary
Willing to discontinue hormonal contraceptives and consent to use of double barrier contraceptive techniques over the course of the study.
Has a negative pregnancy test at the Screening and Baseline visits An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history
A Body Mass Index (BMI) between 18 and 39 inclusive
Is available for all treatment and follow-up visits

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 7 month study period
Women with abnormal liver enzymes or liver disease.
Subject previously participated in Proellex clinical trials: ZPE-201, ZPU-003, ZPU-301, ZPU-302, ZPU-303, ZPU-304, ZPU-305, and ZPU-307.
Received an investigational drug in the 30 days prior to the screening for this study
Women with 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 or hormone releasing IUDs in the preceding 30 days. Use of Depo-Provera® in the preceding 6 months.
Women currently using narcotics
Women currently taking cimetidine or spironolactone
Clinically significant abnormal findings on screening examination 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

Sites / Locations

ICON Devlopment Solutions

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

ARM 1

ARM 2

ARM 3

ARM 4

ARM 5

Arm Description

1 mg Proellex

3 mg Proellex

6 mg Proellex

9 mg Proellex

12 mg proellex

Outcomes

Primary Outcome Measures

Induction Amenorrhea

Induction of amenorrhea as determined by suppression of ovulation and/or menses, measured by using ovulation timing kits and daily diary for bleeding. Five doses will be compared in an escalating-dose, to independent groups, to a run-in placebo treatment period.

Secondary Outcome Measures

Full Information

NCT ID

NCT01187043

First Posted

August 20, 2010

Last Updated

June 27, 2014

Sponsor

Repros Therapeutics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01187043

Brief Title

Determination of the Lowest, Safe and Effective Dose of Proellex

Official Title

A Single-Blind, Placebo Run-in, Phase I/II Study Comparing Five Oral Doses of Proellex®

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

March 2012 (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

The purpose of this study is to determine the effects of five different doses of Proellex on menses, ovulation, liver function, and steady state exposure in women of reproductive age.

Detailed Description

A phase I/II, 5 arm, single blind study, comparing five doses of Proellex to matching placebo in healthy adult female subjects of reproductive age. Exposure to study drug will be for up to 10 weeks. In-clinic pharmacokinetic (PK) assessments will be made on the first day of dosing and on the last day (week 10). Office visits will occur every week to assess liver function and trough blood concentrations for Proellex and primary metabolite. Daily vaginal bleeding diaries will be maintained during the course of the study. A single blind run-in period of up to 56 days will begin the study to assess baseline menstrual patterns will be utilized. Twelve subjects per treatment group (total 60 subjects) will be assigned to each dose. New groups will not begin dosing until the previous dose group has completed. Daily treatments will be either 1 mg, 3 mg, 6 mg, 9 mg, 12 mg Proellex. A single blind run-in period using placebo will be incorporated to establish baseline parameters.

6. Conditions and Keywords

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

Amenorrhea

Keywords

Liver Function, Steady State Exposure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ARM 1

Arm Type

Experimental

Arm Description

1 mg Proellex

Arm Title

ARM 2

Arm Type

Experimental

Arm Description

3 mg Proellex

Arm Title

ARM 3

Arm Type

Experimental

Arm Description

6 mg Proellex

Arm Title

ARM 4

Arm Type

Experimental

Arm Description

9 mg Proellex

Arm Title

ARM 5

Arm Type

Experimental

Arm Description

12 mg proellex

Intervention Type

Drug

Intervention Name(s)

Proellex

Other Intervention Name(s)

CDB-4124, Telapristone acetate

Intervention Description

1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)

Primary Outcome Measure Information:

Title

Induction Amenorrhea

Description

Time Frame

10 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ability to understand and provide a written informed consent. Healthy adult females between 18 and 50 years of age. Included in this group are women with the following conditions, not currently receiving drug treatment: Excessive menstrual bleeding; Menstrual pain; Confirmed uterine fibroids; and Confirmed endometriosis Normal menstrual cycle of 26-32 days Agree not to attempt to become pregnant Agree to limit alcohol consumption to no more than 2 drinks per week and to avoid alcohol consumption within 48 hours of each visit Ability to swallow gelatin capsules Ability to complete a daily subject diary Willing to discontinue hormonal contraceptives and consent to use of double barrier contraceptive techniques over the course of the study. Has a negative pregnancy test at the Screening and Baseline visits An exception for the pregnancy test requirement will be granted for subjects reporting surgical sterilization in medical history A Body Mass Index (BMI) between 18 and 39 inclusive Is available for all treatment and follow-up visits 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 7 month study period Women with abnormal liver enzymes or liver disease. Subject previously participated in Proellex clinical trials: ZPE-201, ZPU-003, ZPU-301, ZPU-302, ZPU-303, ZPU-304, ZPU-305, and ZPU-307. Received an investigational drug in the 30 days prior to the screening for this study Women with 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 or hormone releasing IUDs in the preceding 30 days. Use of Depo-Provera® in the preceding 6 months. Women currently using narcotics Women currently taking cimetidine or spironolactone Clinically significant abnormal findings on screening examination 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura M Sterling, MD

Organizational Affiliation

ICON Development Solutions

Official's Role

Principal Investigator

Facility Information:

Facility Name

ICON Devlopment Solutions

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

12. IPD Sharing Statement

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Determination of the Lowest, Safe and Effective Dose of Proellex

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