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Repros stopped study for safety and the FDA put the study on hold for safety.
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The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | 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. |
|
| 3 mg Proellex | 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. |
|
| 6 mg Proellex | 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. |
|
| 12 mg Proellex | 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. |
|
| 25 mg Proellex | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo, 1 capsule daily for five days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Vaginal Bleeding Following Treatment With Proellex. | At least 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre van As, M.D., Ph.D | Repros Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advances in Health Inc. | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects Enrolled | All subjects initiated treatment with placebo. Further information is not availasble due to premature termination of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Study prematurely terminated, no data available
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 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 |
| BG001 | 3 mg Proellex |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Day of Initial Vaginal Bleeding Event Following Treatment With Proellex. | Study prematurely terminated | Posted | 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 |
|
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No adverse event data is available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Wike | Repros Therapeutics | 2817193402 | jwike@reprosrx.com |
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| ID | Term |
|---|---|
| D000568 | Amenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C461063 | telapristone acetate |
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|
| Proellex | Drug | Proellex, one 3, 6, 12 or 25 mg 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
| BG002 | 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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days |
| BG003 | 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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days |
| BG004 | 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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days |
| BG005 | Total | Total of all reporting groups |
| years |
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days |
| OG003 | 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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days |
| OG004 | 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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days |
|
| Secondary | Duration of Vaginal Bleeding Following Treatment With Proellex. | Study prematurely terminated | Posted | At least 2 days |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days | 0 | 0 | 0 | 0 |
| EG002 | 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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days | 0 | 0 | 0 | 0 |
| EG003 | 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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days | 0 | 0 | 0 | 0 |
| EG004 | 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. Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days | 0 | 0 | 0 | 0 |
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