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17 Diseases |  |
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- | Androxal (enclomifene) / Repros
Journal: Enclomiphene citrate: A treatment that maintains fertility in men with secondary hypogonadism. (Pubmed Central) - May 29, 2020
Initial studies demonstrated that enclomiphene maintains the androgenic benefit of clomiphene citrate without the undesirable effects attributable to zuclomiphene. This article reviews the difficulties associated with the FDA approval of a new molecular entity related to the treatment of hypogonadism.
- | zuclomiphene (VERU-944) / Veru Inc, Androxal (enclomifene) / Repros
Journal: HPT-Axis Effects and Urinary Detection Following Clomiphene Administration in Males. (Pubmed Central) - Dec 21, 2019
Clomiphene significantly raises serum testosterone and gonadotropins in healthy men and thus can be abused as a performance-enhancing drug. Such abuse is detectable in urine for four months or greater following short-term use.
- Androxal (enclomifene) / AbbVie
Enrollment change, Trial withdrawal, Trial primary completion date: Androxal in Male Infertility (clinicaltrials.gov) - Aug 8, 2016
P2b, N=0, Withdrawn, Sponsor: Baylor College of Medicine
Such abuse is detectable in urine for four months or greater following short-term use. N=50 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Aug 2018 --> Jul 2016
- Androxal (enclomifene) / AbbVie
Trial completion: 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 (clinicaltrials.gov) - Mar 12, 2015
P1, N=6, Completed, Sponsor: Repros Therapeutics Inc.
N=50 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Aug 2018 --> Jul 2016 Not yet recruiting --> Completed
- Androxal (enclomifene) / AbbVie
Enrollment open, Trial initiation date: Androxal in Male Infertility (clinicaltrials.gov) - Jan 2, 2015
P2b, N=50, Recruiting, Sponsor: Baylor College of Medicine
Not yet recruiting --> Completed Not yet recruiting --> Recruiting | Initiation date: Sep 2014 --> Dec 2014
- Androxal (enclomifene) / AbbVie
New P1 trial: 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 (clinicaltrials.gov) - Oct 24, 2014
P1, N=6, Not yet recruiting, Sponsor: Repros Therapeutics Inc.
- | Androxal (enclomifene) / AbbVie
Trial completion: An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal (clinicaltrials.gov) - Oct 2, 2014
P1, N=24, Completed, Sponsor: Repros Therapeutics Inc.
Not yet recruiting --> Recruiting | Initiation date: Sep 2014 --> Dec 2014 Active, not recruiting --> Completed
- ||||||| Androxal (enclomifene) / AbbVie
Trial completion: 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% (clinicaltrials.gov) - Oct 2, 2014
P3, N=120, Completed, Sponsor: Repros Therapeutics Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||||| Androxal (enclomifene) / AbbVie
Trial completion: 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% (clinicaltrials.gov) - Oct 2, 2014
P3, N=120, Completed, Sponsor: Repros Therapeutics Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||||||| Androxal (enclomifene) / AbbVie
Trial completion, Trial primary completion date: Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism (clinicaltrials.gov) - Oct 2, 2014
P3, N=300, Completed, Sponsor: Repros Therapeutics Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial primary completion date: Jun 2014 --> Sep 2014
- Androxal (enclomifene) / AbbVie
Enrollment closed: An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal (clinicaltrials.gov) - Aug 11, 2014
P1, N=24, Active, not recruiting, Sponsor: Repros Therapeutics Inc.
Active, not recruiting --> Completed | Trial primary completion date: Jun 2014 --> Sep 2014 Not yet recruiting --> Active, not recruiting
- | Androxal (enclomifene) / AbbVie
Trial completion: Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal (clinicaltrials.gov) - Aug 11, 2014
P1, N=12, Completed, Sponsor: Repros Therapeutics Inc.
Not yet recruiting --> Active, not recruiting Not yet recruiting --> Completed
- | Androxal (enclomifene) / AbbVie
Trial completion: Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males (clinicaltrials.gov) - Aug 11, 2014
P1, N=30, Completed, Sponsor: Repros Therapeutics Inc.
Not yet recruiting --> Completed Active, not recruiting --> Completed
- | Androxal (enclomifene) / AbbVie
Trial completion, Enrollment change: Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function (clinicaltrials.gov) - Aug 11, 2014
P1, N=26, Completed, Sponsor: Repros Therapeutics Inc.
Active, not recruiting --> Completed Recruiting --> Completed | N=21 --> 26
- ||||| Androxal (enclomifene) / AbbVie
Enrollment change: ZA-003Ext: Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism (clinicaltrials.gov) - Jun 27, 2014
P3, N=104, Completed, Sponsor: Repros Therapeutics Inc.
Recruiting --> Completed | N=21 --> 26 N=194 --> 104
- | Androxal (enclomifene) / AbbVie
New P1 trial: An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal (clinicaltrials.gov) - Jun 23, 2014
P1, N=24, Not yet recruiting, Sponsor: Repros Therapeutics Inc.
- Androxal (enclomifene) / AbbVie
Enrollment closed: Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males (clinicaltrials.gov) - Jun 17, 2014
P1, N=30, Active, not recruiting, Sponsor: Repros Therapeutics Inc.
N=194 --> 104 Not yet recruiting --> Active, not recruiting
- ||| Androxal (enclomifene) / AbbVie
Trial completion: A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects (clinicaltrials.gov) - Jun 17, 2014
P1, N=54, Completed, Sponsor: Repros Therapeutics Inc.
Not yet recruiting --> Active, not recruiting Active, not recruiting --> Completed
- Androxal (enclomifene) / AbbVie
New P2b trial: Androxal in Male Infertility (clinicaltrials.gov) - Jun 12, 2014
P2b, N=50, Not yet recruiting, Sponsor: Baylor College of Medicine
- | Androxal (enclomifene) / AbbVie
New P1 trial: Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal (clinicaltrials.gov) - May 21, 2014
P1, N=12, Not yet recruiting, Sponsor: Repros Therapeutics Inc.
- Androxal (enclomifene) / AbbVie
Trial primary completion date: Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males (clinicaltrials.gov) - May 20, 2014
P1, N=30, Not yet recruiting, Sponsor: Repros Therapeutics Inc.
Active, not recruiting --> Completed Trial primary completion date: Dec 2013 --> Aug 2014
- Androxal (enclomifene) / AbbVie
Trial primary completion date: Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function (clinicaltrials.gov) - May 20, 2014
P1, N=21, Recruiting, Sponsor: Repros Therapeutics Inc.
Trial primary completion date: Dec 2013 --> Aug 2014 Trial primary completion date: Mar 2014 --> Jun 2014
- Androxal (enclomifene) / AbbVie
Trial initiation date: Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males (clinicaltrials.gov) - May 20, 2014
P1, N=30, Not yet recruiting, Sponsor: Repros Therapeutics Inc.
Trial primary completion date: Mar 2014 --> Jun 2014 Initiation date: Dec 2013 --> May 2014
- Androxal (enclomifene) / AbbVie
Trial completion date: Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males (clinicaltrials.gov) - May 20, 2014
P1, N=30, Not yet recruiting, Sponsor: Repros Therapeutics Inc.
Initiation date: Dec 2013 --> May 2014 Trial completion date: Jan 2014 --> Aug 2014
- Androxal (enclomifene) / AbbVie
Trial completion date: Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function (clinicaltrials.gov) - May 20, 2014
P1, N=21, Recruiting, Sponsor: Repros Therapeutics Inc.
Trial completion date: Jan 2014 --> Aug 2014 Trial completion date: May 2014 --> Jun 2014
- Androxal (enclomifene) / AbbVie
Enrollment change: Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males (clinicaltrials.gov) - May 20, 2014
P1, N=30, Not yet recruiting, Sponsor: Repros Therapeutics Inc.
Trial completion date: May 2014 --> Jun 2014 N=18 --> 30
- ||||| Androxal (enclomifene) / AbbVie
Enrollment closed: 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% (clinicaltrials.gov) - May 20, 2014
P3, N=120, Active, not recruiting, Sponsor: Repros Therapeutics Inc.
N=18 --> 30 Recruiting --> Active, not recruiting
- ||| Androxal (enclomifene) / AbbVie
New P1 trial: A Thorough QT/QTc Study to Assess the Effects of Androxal in Healthy Male Subjects (clinicaltrials.gov) - Apr 17, 2014
P1, N=54, Active, not recruiting, Sponsor: Repros Therapeutics Inc.
- ||||| Androxal (enclomifene) / AbbVie
Enrollment closed: 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% (clinicaltrials.gov) - Apr 14, 2014
P3, N=120, Active, not recruiting, Sponsor: Repros Therapeutics Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- ||||||| Androxal (enclomifene) / AbbVie
Trial completion: An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism (clinicaltrials.gov) - Apr 14, 2014
P3, N=300, Completed, Sponsor: Repros Therapeutics Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- Androxal (enclomifene) / AbbVie
Enrollment open: Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function (clinicaltrials.gov) - Jan 22, 2014
P1, N=21, Recruiting, Sponsor: Repros Therapeutics Inc.
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- | Androxal (enclomifene) / AbbVie
Trial completion: Comparison of Two Formulations of Androxal (clinicaltrials.gov) - Jan 22, 2014
P1, N=16, Completed, Sponsor: Repros Therapeutics Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Completed
- | Androxal (enclomifene) / AbbVie
Trial completion: Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function (clinicaltrials.gov) - Jan 22, 2014
P1, N=19, Completed, Sponsor: Repros Therapeutics Inc.
Not yet recruiting --> Completed Not yet recruiting --> Completed
- |||||| Androxal (enclomifene) / AbbVie
Enrollment open: 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% (clinicaltrials.gov) - Jan 15, 2014
P3, N=120, Recruiting, Sponsor: Repros Therapeutics Inc.
Not yet recruiting --> Completed Not yet recruiting --> Recruiting
- |||||||||| Androxal (enclomifene) / AbbVie
New P3 trial: 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% (clinicaltrials.gov) - Nov 21, 2013
P3, N=120, Active, not recruiting, Sponsor: Repros Therapeutics Inc.
- |||||||||| Androxal (enclomifene) / AbbVie
New P3 trial: 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% (clinicaltrials.gov) - Nov 21, 2013
P3, N=120, Recruiting, Sponsor: Repros Therapeutics Inc.
- | Androxal (enclomifene) / AbbVie
New P1 trial: Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males (clinicaltrials.gov) - Nov 17, 2013
P1, N=18, Not yet recruiting, Sponsor: Repros Therapeutics Inc.
- | Androxal (enclomifene) / AbbVie
New P1 trial: Comparison of Two Formulations of Androxal (clinicaltrials.gov) - Nov 12, 2013
P1, N=16, Completed, Sponsor: Repros Therapeutics Inc.
- Androxal (enclomifene) / AbbVie
Trial completion: A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal (clinicaltrials.gov) - Nov 5, 2013
P1, N=9, Completed, Sponsor: Repros Therapeutics Inc.
Not yet recruiting --> Recruiting Recruiting --> Completed
- ||||| Androxal (enclomifene) / AbbVie
Enrollment closed: Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism (clinicaltrials.gov) - Oct 21, 2013
P3, N=300, Active, not recruiting, Sponsor: Repros Therapeutics Inc.
Recruiting --> Completed Recruiting --> Active, not recruiting
- ||||||| Androxal (enclomifene) / AbbVie
Trial completion: Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism (clinicaltrials.gov) - Oct 21, 2013
P3, N=181, Completed, Sponsor: Repros Therapeutics Inc.
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- ||||||| Androxal (enclomifene) / AbbVie
Trial completion: Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism (clinicaltrials.gov) - Oct 21, 2013
P3, N=499, Completed, Sponsor: Repros Therapeutics Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- Androxal (enclomifene) / AbbVie
New P1 trial: A Dose Escalating Study to Determine the Tolerability and PK of a Single Dose of Androxal (clinicaltrials.gov) - Oct 8, 2013
P1, N=9, Completed, Sponsor: Repros Therapeutics Inc.
- | Androxal (enclomifene) / AbbVie
New P1 trial: Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function (clinicaltrials.gov) - Aug 14, 2013
P1, N=19, Completed, Sponsor: Repros Therapeutics Inc.
- | Androxal (enclomifene) / AbbVie
New P1 trial: Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function (clinicaltrials.gov) - Aug 14, 2013
P1, N=21, Recruiting, Sponsor: Repros Therapeutics Inc.
- ||||| Androxal (enclomifene) / AbbVie
Enrollment change: Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism (clinicaltrials.gov) - Jun 3, 2013
P3, N=300, Active, not recruiting, Sponsor: Repros Therapeutics Inc.
Active, not recruiting --> Completed N=150 --> 300
- | Androxal (enclomifene) / AbbVie
Enrollment change: A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203 (clinicaltrials.gov) - May 15, 2013
P2, N=48, Completed, Sponsor: Repros Therapeutics Inc.
N=150 --> 300 N=120 --> 48
- ||||||| Androxal (enclomifene) / AbbVie
Trial completion: Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism (clinicaltrials.gov) - May 15, 2013
P3, N=151, Completed, Sponsor: Repros Therapeutics Inc.
N=120 --> 48 Active, not recruiting --> Completed
- | Androxal (enclomifene) / AbbVie
Trial completion: A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203 (clinicaltrials.gov) - May 15, 2013
P2, N=48, Completed, Sponsor: Repros Therapeutics Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- |||||||||| Androxal (enclomifene) / AbbVie
New P3 trial: Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism (clinicaltrials.gov) - Nov 29, 2012
P3, N=181, Completed, Sponsor: Repros Therapeutics Inc.