Study to Evaluate Menses Induction in Women Administered Proellex

• Sponsor: Repros Therapeutics Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00881608
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 5
• Duration (Months): 5.9
• Patients Per Site Per Month: 1.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Amenorrhea	Drug: Placebo; Drug: Proellex	Phase 1

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 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; Placebo, 1 capsule daily for five days; Other Names: Dummy
Experimental: 3 mg Proellex 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; Proellex, one 3, 6, 12 or 25 mg capsule daily for five days; Other Names: Telapristone acetate
Experimental: 6 mg Proellex 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; Proellex, one 3, 6, 12 or 25 mg capsule daily for five days; Other Names: Telapristone acetate
Experimental: 12 mg Proellex 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; Proellex, one 3, 6, 12 or 25 mg capsule daily for five days; Other Names: Telapristone acetate
Experimental: 25 mg Proellex 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; Proellex, one 3, 6, 12 or 25 mg capsule daily for five days; Other Names: Telapristone acetate

Outcome Measures

Primary Outcome Measures

1. Day of Initial Vaginal Bleeding Event Following Treatment With Proellex. [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 Measures

1. Duration of Vaginal Bleeding Following Treatment With Proellex. [At least 2 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Repros Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT00881608
• Other Study ID Numbers: ZP-010
• First Posted: Apr 15, 2009
• Last Update Posted: Aug 25, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by Repros Therapeutics Inc.: Menstruation
• Additional relevant MeSH terms: Amenorrhea

Study Results

Participant Flow

Arm/Group Title	All Subjects Enrolled
Arm/Group Description	All subjects initiated treatment with placebo. Further information is not availasble due to premature termination of the study.
Period Title: Overall Study
STARTED	11
COMPLETED	0
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	Placebo	3 mg Proellex	6 mg Proellex	12 mg Proellex	25 mg Proellex	Total
Arm/Group Description	Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18. Placebo: Placebo, 1 capsule daily for five days	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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days	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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days	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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days	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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days	Total of all reporting groups
Overall Participants	0	0	0	0	0	0
Age (years) [Mean (Standard Deviation) ]
Age (Count of Participants)
Sex: Female, Male (Count of Participants)
Region of Enrollment (participants) [Number]

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Study prematurely terminated

Arm/Group Title	Placebo	3 mg Proellex	6 mg Proellex	12 mg Proellex	25 mg Proellex
Arm/Group Description	Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18. Placebo: Placebo, 1 capsule daily for five days	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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days	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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days	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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days	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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days
Measure Participants	0	0	0	0	0

2. Secondary Outcome

Title	Duration of Vaginal Bleeding Following Treatment With Proellex.
Time Frame	At least 2 days

Outcome Measure Data

Analysis Population Description

Study prematurely terminated

Arm/Group Title	Placebo	3 mg Proellex	6 mg Proellex	12 mg Proellex	25 mg Proellex
Arm/Group Description	Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18. Placebo: Placebo, 1 capsule daily for five days	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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days	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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days	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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days	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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days
Measure Participants	0	0	0	0	0

Adverse Events

Adverse Event Reporting Description	No adverse event data is available.
Arm/Group Title	Placebo		3 mg Proellex		6 mg Proellex		12 mg Proellex		25 mg Proellex
Arm/Group Description	Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18. Placebo: Placebo, 1 capsule daily for five days		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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days		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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days		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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days		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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days
All Cause Mortality
	Placebo		3 mg Proellex		6 mg Proellex		12 mg Proellex		25 mg Proellex
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		3 mg Proellex		6 mg Proellex		12 mg Proellex		25 mg Proellex
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Placebo		3 mg Proellex		6 mg Proellex		12 mg Proellex		25 mg Proellex
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

The study was prematurely terminated for safety reasons (Proellex studies were put on clinical hold due to liver toxicity). Sponsor was unable to pay vendor, and was therefore not provided with any study data.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights