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Study to Evaluate Menses Induction in Women Administered Proellex

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:
NCT00881608
First received: April 14, 2009
Last updated: February 10, 2010
Last verified: February 2010
History of Changes
  Purpose

The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.


Condition Intervention Phase
Amenorrhea
 Drug: Placebo
Drug: Proellex
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Escalating Dose, Single Center, Cross-over Design, Phase I Study to Evaluate Menses Induction in Women Administered Proellex

Resource links provided by NLM:

MedlinePlus related topics: Menstruation
U.S. FDA Resources

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of vaginal bleeding following treatment with Proellex. [ Time Frame: At least 2 days ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.
 Drug: Placebo
1 capsule daily for five days
Experimental: 2
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.
 Drug: Proellex
1, 3 mg capsule daily for five days
Experimental: 3
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.
 Drug: Proellex
6 mg (2,3 mg capsules) daily for five days
Experimental: 4
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.
 Drug: Proellex
12 mg (4, 3 mg capsules) daily for five days
Experimental: 5
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.
 Drug: Proellex
One, 25 mg capsule daily for five days

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881608

Locations
United States, Texas
Advances in Health Inc.
Houston, Texas, United States, 77030
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
Study Director: Andre van As, M.D., Ph.D Repros Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Andre van As, MD, PhD, Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00881608     History of Changes
Other Study ID Numbers: ZP-010
Study First Received: April 14, 2009
Last Updated: February 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Menstruation

Additional relevant MeSH terms:
Amenorrhea
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013