Study to Evaluate Menses Induction in Women Administered Proellex - Full Text View

Sponsored by:	Repros Therapeutics Inc.
Information provided by:	Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT00881608

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 I

MedlinePlus related topics: Menstruation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Escalating Dose, Single Center, Cross-Over Design, Phase I Study to Evaluate Menses Induction in Women Administered Proellex

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 ]

Estimated Enrollment:	10
Study Start Date:	February 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator 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
2: Experimental 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
3: Experimental 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
4: Experimental 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
5: Experimental 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

Contacts

Contact: Ronald Weihle, Ph.D

281-719-3400

Locations

United States, Texas
Advances in Health Inc.	Recruiting
Houston, Texas, United States, 77030
Contact: Angela Rangel 713-795-5964 adv_hlth@swbell.net
Contact: LaTonya Mayes 713-795-5964 adv_hlth@swbell.net
Principal Investigator: Alfred N. Poindexter III, MD

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

Keywords provided by Repros Therapeutics Inc.:

Menstruation

Study placed in the following topic categories:

Menstruation Disturbances
Amenorrhea

Additional relevant MeSH terms:

Pathologic Processes
Menstruation Disturbances
Amenorrhea

ClinicalTrials.gov processed this record on May 07, 2009