Study to Evaluate Menses Induction in Women Administered Proellex

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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An Open-Label, Escalating Dose, Single Center, Cross-over Design, Phase I Study to Evaluate Menses Induction in Women Administered Proellex

Conditions
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Amenorrhea

Intervention / Treatment
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* Drug: Placebo
* Drug: Proellex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* Placebo, 1 capsule daily for five days<br>* Other names: Dummy;|
| Experimental: 3 mg Proellex<br>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<br>* Proellex, one 3, 6, 12 or 25 mg capsule daily for five days<br>* Other names: Telapristone acetate;|
| Experimental: 6 mg Proellex<br>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<br>* Proellex, one 3, 6, 12 or 25 mg capsule daily for five days<br>* Other names: Telapristone acetate;|
| Experimental: 12 mg Proellex<br>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<br>* Proellex, one 3, 6, 12 or 25 mg capsule daily for five days<br>* Other names: Telapristone acetate;|
| Experimental: 25 mg Proellex<br>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<br>* Proellex, one 3, 6, 12 or 25 mg capsule daily for five days<br>* Other names: Telapristone acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Vaginal Bleeding Following Treatment With Proellex. |  | At least 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menstruation