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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00881608
• Other study ID #: ZP-010
• Status: Terminated
• Phase: Phase 1
• First received: April 14, 2009
• Last updated: August 8, 2014
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: August 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

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

Intervention

Drug:
• Placebo
Placebo, 1 capsule daily for five days
• Proellex
Proellex, one 3, 6, 12 or 25 mg capsule daily for five days

Locations

Country	Name	City	State
United States	Advances in Health Inc.	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Duration of Vaginal Bleeding Following Treatment With Proellex.		At least 2 days	Yes