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
A Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene
Phase 2
Completed
- Conditions
- Acquired Hypogonadotropic HypogonadismObesity
- Interventions
- Drug: Placebo
- First Posted Date
- 2016-01-11
- Last Posted Date
- 2019-06-27
- Lead Sponsor
- Repros Therapeutics Inc.
- Target Recruit Count
- 50
- Registration Number
- NCT02651688
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
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
An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration
- First Posted Date
- 2014-10-24
- Last Posted Date
- 2015-03-12
- Lead Sponsor
- Repros Therapeutics Inc.
- Target Recruit Count
- 6
- Registration Number
- NCT02274181
- Locations
- 🇺🇸
Celerion, Lincoln, Nebraska, United States
An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal
Phase 1
Completed
- Conditions
- Pharmacokinetics
- Interventions
- Drug: Androxal 25 mg
- First Posted Date
- 2014-06-23
- Last Posted Date
- 2014-10-01
- Lead Sponsor
- Repros Therapeutics Inc.
- Target Recruit Count
- 24
- Registration Number
- NCT02169804
Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal
Phase 1
Completed
- Conditions
- Normal Volunteers
- Interventions
- Drug: Androxal 25 mg Capsules
- First Posted Date
- 2014-05-23
- Last Posted Date
- 2014-08-11
- Lead Sponsor
- Repros Therapeutics Inc.
- Target Recruit Count
- 12
- Registration Number
- NCT02146391
Comparison of Two Formulations of Proellex for Oral Administration
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Telapristone Acetate, Proellex 12 mg Formulation ADrug: Telapristone Acetate, Proellex 12 mg Formulation B
- First Posted Date
- 2014-05-19
- Last Posted Date
- 2014-09-03
- Lead Sponsor
- Repros Therapeutics Inc.
- Target Recruit Count
- 12
- Registration Number
- NCT02141061
A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Androxal 25 mg capsulesDrug: Androxal 250 CapsulesDrug: Placebo Capsules
- First Posted Date
- 2014-04-21
- Last Posted Date
- 2014-06-16
- Lead Sponsor
- Repros Therapeutics Inc.
- Target Recruit Count
- 54
- Registration Number
- NCT02117830
A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%
Phase 3
Completed
- Conditions
- Secondary Hypogonadism
- Interventions
- First Posted Date
- 2013-11-25
- Last Posted Date
- 2014-10-01
- Lead Sponsor
- Repros Therapeutics Inc.
- Target Recruit Count
- 120
- Registration Number
- NCT01993212
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