Telapristone acetate

Generic Name: Telapristone acetate

Drug Type: Small Molecule

Chemical Formula: C_₃₁H_₃₉NO_₅

CAS Number: 198414-31-2

Unique Ingredient Identifier: 1K9EYK92PQ

Background: Telapristone acetate, an orally-available, selective progesterone receptor modulator, is in development to alleviate symptoms associated with both uterine fibroids and endometriosis.

Indication: For the treatment of uterine fibroids and endometriosis.

Clinical Trials

Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids

Phase 3

Terminated

Conditions: Uterine Fibroids

Interventions: Drug: Proellex

First Posted Date: 2010-02-17

Last Posted Date: 2014-08-21

Lead Sponsor: Repros Therapeutics Inc.

Target Recruit Count: 27

Registration Number: NCT01069120

Locations: 🇺🇸
Advances in Health Inc, Houston, Texas, United States
🇺🇸
The Women's Hospital of Texas, Clinical Research Center, Houston, Texas, United States
🇺🇸
Visions Clinical Research, Boynton Beach, Florida, United States

and more 1 locations

Study to Evaluate Menses Induction in Women Administered Proellex

Phase 1

Terminated

Conditions: Amenorrhea

Interventions: Drug: Placebo
Drug: Proellex

First Posted Date: 2009-04-15

Last Posted Date: 2014-08-25

Lead Sponsor: Repros Therapeutics Inc.

Target Recruit Count: 11

Registration Number: NCT00881608

Locations: 🇺🇸
Advances in Health Inc., Houston, Texas, United States

Investigate Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose in Healthy Females

Phase 1

Completed

Conditions: ABSORPTION
METABOLISM
EXCRETION

Interventions: Drug: Proellex

First Posted Date: 2009-04-15

Last Posted Date: 2014-07-08

Lead Sponsor: Repros Therapeutics Inc.

Target Recruit Count: 6

Registration Number: NCT00881062

Locations: 🇺🇸
Covance Clinical Research Unit Inc., Madison, Wisconsin, United States

Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms

Phase 3

Withdrawn

Conditions: Uterine Fibroids

Interventions: Drug: Proellex

First Posted Date: 2009-04-02

Last Posted Date: 2014-06-27

Lead Sponsor: Repros Therapeutics Inc.

Registration Number: NCT00874302

Locations: 🇺🇸
Genesis Center for Clinical Research, San Diego, California, United States
🇺🇸
Thomas Jefferson University - Jefferson Center for Women's Medical Specialties, Philadelphia, Pennsylvania, United States
🇧🇷
Universidade Federal de São Paulo - UNIFESP, São Paulo, Brazil

and more 17 locations

Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids

Phase 3

Terminated

Conditions: Uterine Fibroids

Interventions: Other: placebo
Drug: Proellex

First Posted Date: 2009-03-02

Last Posted Date: 2014-08-21

Lead Sponsor: Repros Therapeutics Inc.

Target Recruit Count: 71

Registration Number: NCT00853567

Locations: 🇺🇸
Comprehensive Clinical Trials, LLC, West Palm Beach, Florida, United States
🇺🇸
Central Brooklyn Medical Group (eCast), Brooklyn, New York, United States
🇺🇸
Impact Clinical Trials, Los Angeles, California, United States

and more 13 locations

Crossover Study of the Safety and PK Properties of Proellex®

Phase 1

Completed

Conditions: Pharmacokinetics

Interventions: Drug: Proellex

First Posted Date: 2008-09-09

Last Posted Date: 2019-04-29

Lead Sponsor: Repros Therapeutics Inc.

Target Recruit Count: 17

Registration Number: NCT00749879

Locations: 🇺🇸
Healthcare Discoveries Inc., San Antonio, Texas, United States

Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects

Phase 1

Completed

Conditions: Drug Interactions

Interventions: Drug: Proellex
Drug: CYP1A2 probe
Drug: CYP2C9 probe
Drug: CYP2C19 probe
Drug: CYP2D6 probe
Drug: CYP3A4 probe

First Posted Date: 2008-08-26

Last Posted Date: 2014-08-22

Lead Sponsor: Repros Therapeutics Inc.

Target Recruit Count: 18

Registration Number: NCT00741468

Locations: 🇺🇸
Clinical Research Center Advanced Biomedical Research Inc., Hackensack, New Jersey, United States

Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults

Phase 1

Completed

Conditions: Impaired Liver Function

Interventions: Drug: Proellex

First Posted Date: 2008-08-26

Last Posted Date: 2014-08-28

Lead Sponsor: Repros Therapeutics Inc.

Target Recruit Count: 16

Registration Number: NCT00741273

Locations: 🇺🇸
Clinical Pharmacology of Miami, Inc., Miami, Florida, United States
🇺🇸
Orlando Clinical Research Center, Orlando, Florida, United States

Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids

Phase 3

Terminated

Conditions: Uterine Fibroids

Interventions: Drug: Placebo
Drug: Proellex

First Posted Date: 2008-08-15

Last Posted Date: 2014-08-21

Lead Sponsor: Repros Therapeutics Inc.

Target Recruit Count: 77

Registration Number: NCT00735553

Locations: 🇺🇸
Genova Clinical Research, Inc., Tucson, Arizona, United States
🇺🇸
Women's Health Research, Phoenix, Arizona, United States
🇺🇸
Women's Health Care at Frost Steet, San Diego, California, United States

and more 12 locations

A Safety and Pharmacokinetic Study of Proellex®

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Proellex

First Posted Date: 2008-02-21

Last Posted Date: 2014-08-08

Lead Sponsor: Repros Therapeutics Inc.

Target Recruit Count: 25

Registration Number: NCT00619385

Locations: 🇺🇸
Healthcare Discoveries Inc., San Antonio, Texas, United States

Drug Development Updates

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