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An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids | Clinical Trials | Clareo Health

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An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

An Open-Label Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

NCT02811159•Repros Therapeutics Inc.

View on ClinicalTrials.gov

Summary

To determine the safety of extended treatment with Proellex® in women who have successfully completed either study ZPV-201 \[NCT02323646\] or ZPU-203 \[NCT02301897\] and meet eligibility criteria.

Detailed Description

This study will be for participants who had completed either ZPV-201 or ZPU-203.

Eligibility

Age

18 - 47 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Completed either study ZPV-201 \[NCT02323646\] or ZPU-203 \[NCT02301897\]
•Agreement not to attempt to become pregnant during the trial
•Agreement to use alcohol in moderation and record the daily consumption (note: elevated liver enzymes may result in discontinuation from the study)
•Ability to complete a daily subject diary and study procedures in compliance with the protocol
•Women of child-bearing potential must be willing to use double-barrier contraception during the study and off-drug intervals. Acceptable double-barrier methods are: male condom with spermicide; male condom with diaphragm; diaphragm containing spermicide plus additional intra-vaginal spermicide
•Has a negative pregnancy test at Visit 1
•Subject is available for all treatment and follow-up visits

Exclusion Criteria

•Subject had a significant decrease in bone mineral density while participating in ZPV-201 or ZPU-203 (total hip or spine measurement decreased by 5% or more)
•Subject has undergone hysterectomy and/or bilateral oophorectomy since enrollment in ZPV-201 or ZPU-203
•Subject is pregnant or lactating or is attempting or expecting to become pregnant during the entire study period
•Subjects with abnormally high liver enzymes or liver disease. \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding 2 x upper limit of normal (ULN) and total bilirubin exceeding 1.5 x ULN at Visit 1 and confirmed on repeat\].
•Subject has a hemoglobin of \<7.5 grams per deciliter (g/dL) at Visit 1
•Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, dehydroepiandrosterone (DHEA) or hormonal products for at least 2 weeks prior to Visit 1
•Use of oral contraceptives in the 30 days preceding screening. Use of Depo-Provera® in the preceding 10 months
•Use of Gonadotrophin releasing hormone agonist (GnRHas) (e.g. Lupron Depot) within 3 months prior to screening (Lupron Depot must have a wash-out period of 3 months prior to screening)
•Has an intra-uterine device (IUD) in place
•Current cervical dysplasia classified as Atypical Squamous Cells of Undetermined Significance (ASCUS) associated with high-risk human papilloma virus (HPV)
+6 more criteria

Locations (8)

KO Clinical Research, LLC

Fort Lauderdale, Florida, United States

Atlanta Women's Research Institute, Inc.

Atlanta, Georgia, United States

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, United States

Southern Clinical Research Associates, LLC

Metairie, Louisiana, United States

The Jackson Clinic, PA

Jackson, Tennessee, United States

Advances in Health

Houston, Texas, United States

The Women's Hospital of Texas Clinical Research Center

Houston, Texas, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Key Dates

Start Date

July 26, 2016

Primary Completion Date

May 4, 2017

Completion Date

May 4, 2017

Last Updated

June 27, 2019

Enrollment

ACTUAL participants

Conditions

Uterine Fibroids

Interventions

Telapristone acetate

DRUG

Laparoscopic Myomectomy Based on a Fully Enclosed Protective Device: A Novel Surgical Technique Achieving Tumor-Free Protection Throughout the Entire Procedure

NCT07474688

Uterine Fibroids (Leiomyoma)

View study

NOT_YET_RECRUITING

POPQ Associated With Total Laparoscopic Hysterectomy

NCT07137299

Uterine Fibroids (UF)Abnormal Uterine Bleeding Unrelated to Menstrual Cycle+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

Inclusion Criteria

Exclusion Criteria

Laparoscopic Myomectomy Based on a Fully Enclosed Protective Device: A Novel Surgical Technique Achieving Tumor-Free Protection Throughout the Entire Procedure

POPQ Associated With Total Laparoscopic Hysterectomy

A Trial of SHR7280 in Healthy Subjects

Point of Care 3D Ultrasound for Various Applications: A Pilot Study

Laparoscopic Cryoablation of Uterine Fibroids

Treatment of Heavy Menstrual Bleeding in Women With Uterine Fibroids