NCT00881608

Study to Evaluate Menses Induction in Women Administered Proellex

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

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

Conditions

• Amenorrhea

Interventions

Type	Name	Description
DRUG	Placebo	Placebo, 1 capsule daily for five days
DRUG	Proellex	Proellex, one 3, 6, 12 or 25 mg capsule daily for five days

Timeline

• Start date: 2009-02-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2009-04-15
• Last updated: 2014-08-25
• Results posted: 2014-08-25

Locations

1 site across 1 country: United States