Telapristone acetate
- Generic Name
- Telapristone acetate
- Drug Type
- Small Molecule
- Chemical Formula
- C31H39NO5
- 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.
An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
- First Posted Date
- 2016-06-23
- Last Posted Date
- 2019-06-27
- Lead Sponsor
- Repros Therapeutics Inc.
- Target Recruit Count
- 20
- Registration Number
- NCT02811159
- Locations
- 🇺🇸
The Jackson Clinic, PA, Jackson, Tennessee, United States
🇺🇸Southern Clinical Research Associates, LLC, Metairie, Louisiana, United States
🇺🇸Atlanta Women's Research Institute, Inc., Atlanta, Georgia, United States
Safety and Efficacy of Telapristone Acetate (Proellex®) Administered Vaginally for the Treatment of Uterine Fibroids
- First Posted Date
- 2014-12-23
- Last Posted Date
- 2019-06-25
- Lead Sponsor
- Repros Therapeutics Inc.
- Target Recruit Count
- 42
- Registration Number
- NCT02323646
Transdermal or Oral Telapristone Acetate in Treating Patients Undergoing Mastectomy
- Conditions
- Stage IIA Breast CancerStage IIB Breast CancerStage 0 Breast CancerStage IA Breast CancerBRCA1 Mutation CarrierLobular Breast Carcinoma In SituBRCA2 Mutation CarrierDuctal Breast Carcinoma In SituStage IB Breast Cancer
- Interventions
- Other: PlaceboOther: Laboratory Biomarker AnalysisOther: Questionnaire Administration
- First Posted Date
- 2014-12-11
- Last Posted Date
- 2023-02-22
- Lead Sponsor
- Northwestern University
- Target Recruit Count
- 67
- Registration Number
- NCT02314156
- Locations
- 🇺🇸
Cedars-Sinai Medical Center, West Hollywood, California, United States
🇺🇸Northwestern University, Chicago, Illinois, United States
🇺🇸Memorial Sloan-Kettering Cancer Center, New York, New York, United States
A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
- First Posted Date
- 2014-11-26
- Last Posted Date
- 2019-06-19
- Lead Sponsor
- Repros Therapeutics Inc.
- Target Recruit Count
- 43
- Registration Number
- NCT02301897
- Locations
- 🇺🇸
KO Clinical Research, LLC, Fort Lauderdale, Florida, United States
🇺🇸South Florida Clinical Research Institute, Margate, Florida, United States
🇺🇸Atlanta Women's Research Institute, Inc., Atlanta, Georgia, United States
Open-Label Extension Study to ZPE-202
- First Posted Date
- 2013-10-14
- Last Posted Date
- 2014-02-07
- Lead Sponsor
- Repros Therapeutics Inc.
- Registration Number
- NCT01961908
Oral CDB-4124 vs. Placebo in Stage I-II Primary Breast Cancer
- Conditions
- Stage IA Breast CancerStage IB Breast CancerStage II Breast Cancer
- Interventions
- Other: placeboProcedure: therapeutic conventional surgeryOther: laboratory biomarker analysisOther: questionnaire administration
- First Posted Date
- 2013-02-27
- Last Posted Date
- 2020-01-18
- Lead Sponsor
- Northwestern University
- Target Recruit Count
- 50
- Registration Number
- NCT01800422
- Locations
- 🇺🇸
Northwestern University, Chicago, Illinois, United States
Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis
- First Posted Date
- 2012-11-19
- Last Posted Date
- 2019-07-23
- Lead Sponsor
- Repros Therapeutics Inc.
- Target Recruit Count
- 60
- Registration Number
- NCT01728454
Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids
- First Posted Date
- 2011-10-13
- Last Posted Date
- 2014-08-29
- Lead Sponsor
- Repros Therapeutics Inc.
- Target Recruit Count
- 40
- Registration Number
- NCT01451424
- Locations
- 🇺🇸
Advances in Health, Houston, Texas, United States
🇺🇸Cetero Research, Miami Gardens, Florida, United States
Determination of the Lowest, Safe and Effective Dose of Proellex
- First Posted Date
- 2010-08-23
- Last Posted Date
- 2014-07-28
- Lead Sponsor
- Repros Therapeutics Inc.
- Target Recruit Count
- 52
- Registration Number
- NCT01187043
- Locations
- 🇺🇸
ICON Devlopment Solutions, San Antonio, Texas, United States
A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
- Conditions
- Uterine Leiomyomata
- Interventions
- First Posted Date
- 2010-02-17
- Last Posted Date
- 2014-06-30
- Lead Sponsor
- Repros Therapeutics Inc.
- Target Recruit Count
- 29
- Registration Number
- NCT01069094
- Locations
- 🇵🇱
Medical University /MTZ Clinical Research Sp.zo.o., Warsaw, Poland
Drug Development Updates
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