Study to Evaluate Menses Induction in Women Administered Proellex

Amenorrhea Clinical Trial

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

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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 ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amenorrhea

• NCT number: NCT00881608
• Study type: Interventional
• Source: Repros Therapeutics Inc.
• Status: Terminated
• Phase: Phase 1
• Start date: February 2009
• Completion date: August 2009