Study to Evaluate Menses Induction in Women Administered Proellex

Repros Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Amenorrhea

Treatments: Drug: Proellex; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881608

ZP-010

Details and patient eligibility

About

The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.

Full 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

Enrollment: 11 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator 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.

Treatment:

Drug: Placebo

3 mg Proellex

Experimental group

Description:

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.

Treatment:

Drug: Proellex

6 mg Proellex

Experimental group

Description:

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.

Treatment:

Drug: Proellex

12 mg Proellex

Experimental group

Description:

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.

Treatment:

Drug: Proellex

25 mg Proellex

Experimental group

Description:

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.

Treatment:

Drug: Proellex