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Study to Evaluate Menses Induction in Women Administered Proellex

Primary Purpose

Amenorrhea

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
Proellex
Sponsored by
Repros Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amenorrhea focused on measuring Menstruation

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical laboratory tests within normal ranges
  • A normal menstrual period of 26-30 days
  • Desiring not to become pregnant
  • Agreeing to use a double barrier method of birth control for the duration of the trial

Exclusion Criteria:

  • Post-menopausal status
  • Aamenorrhea or dysfunctional uterine bleeding
  • Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile
  • Subjects with a Body Mass Index (BMI) below 18 or over 39

Sites / Locations

  • Advances in Health Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

3 mg Proellex

6 mg Proellex

12 mg Proellex

25 mg Proellex

Arm Description

Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.

First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.

Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.

Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.

Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.

Outcomes

Primary Outcome Measures

Day of Initial Vaginal Bleeding Event Following Treatment With Proellex.

Secondary Outcome Measures

Duration of Vaginal Bleeding Following Treatment With Proellex.

Full Information

First Posted
April 14, 2009
Last Updated
August 8, 2014
Sponsor
Repros Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00881608
Brief Title
Study to Evaluate Menses Induction in Women Administered Proellex
Official Title
An Open-Label, Escalating Dose, Single Center, Cross-over Design, Phase I Study to Evaluate Menses Induction in Women Administered Proellex
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Repros stopped study for safety and the FDA put the study on hold for safety.
Study Start Date
February 2009 (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
No

5. Study Description

Brief Summary
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.
Detailed Description
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able to suppress endogenous progesterone in women. It is believed that giving Proellex in the early/mid-luteal phase of the cycle will suppress the effects of endogenous progesterone triggering the end of the cycle and inducing menstruation as happens naturally

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.
Arm Title
3 mg Proellex
Arm Type
Experimental
Arm Description
First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.
Arm Title
6 mg Proellex
Arm Type
Experimental
Arm Description
Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.
Arm Title
12 mg Proellex
Arm Type
Experimental
Arm Description
Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.
Arm Title
25 mg Proellex
Arm Type
Experimental
Arm Description
Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Dummy
Intervention Description
Placebo, 1 capsule daily for five days
Intervention Type
Drug
Intervention Name(s)
Proellex
Other Intervention Name(s)
Telapristone acetate
Intervention Description
Proellex, one 3, 6, 12 or 25 mg capsule daily for five days
Primary Outcome Measure Information:
Title
Day of Initial Vaginal Bleeding Event Following Treatment With Proellex.
Time Frame
An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses
Secondary Outcome Measure Information:
Title
Duration of Vaginal Bleeding Following Treatment With Proellex.
Time Frame
At least 2 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical laboratory tests within normal ranges A normal menstrual period of 26-30 days Desiring not to become pregnant Agreeing to use a double barrier method of birth control for the duration of the trial Exclusion Criteria: Post-menopausal status Aamenorrhea or dysfunctional uterine bleeding Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile Subjects with a Body Mass Index (BMI) below 18 or over 39
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre van As, M.D., Ph.D
Organizational Affiliation
Repros Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Advances in Health Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Study to Evaluate Menses Induction in Women Administered Proellex

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