Study to Evaluate Menses Induction in Women Administered Proellex

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-08-31

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.

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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

Conditions

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Amenorrhea

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

Proellex, one 3, 6, 12 or 25 mg capsule daily for five days

Interventions

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Placebo

Placebo, 1 capsule daily for five days

Intervention Type DRUG

Proellex

Proellex, one 3, 6, 12 or 25 mg capsule daily for five days

Intervention Type DRUG

Other Intervention Names

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Dummy Telapristone acetate

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes