Androxal (enclomifene) / AbbVie - LARVOL DELTA

Leydig stem cells and future therapies for hypogonadism. (PubMed, Curr Opin Endocrinol Diabetes Obes) - "LSC therapies provide an effective way of increasing testosterone levels without detrimentally affecting gonadotropin levels. Next steps in developing viable Leydig cell grafting options for the treatment of hypogonadism should include the assessment of efficacy and potency of current animal models in human trials. Recently, both intranasal and oral testosterone have been made available and shown promising results in treating hypogonadism while maintaining fertility. Enclomiphene citrate and selective androgen receptor modulators have been suggested as future therapies for hypogonadism; however, further studies assessing efficacy and adverse effects are needed."

Journal

Enclomiphene citrate: A treatment that maintains fertility in men with secondary hypogonadism. (PubMed, Expert Rev Endocrinol Metab) - "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."

Journal

An Open-Label Study to Evaluate the Effect of Age Upon the Pharmacokinetics of Androxal (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: Repros Therapeutics Inc.; Active, not recruiting -> Completed

Trial completion • Biosimilar

Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism (clinicaltrials.gov) - P3; N=104; Completed; Sponsor: Repros Therapeutics Inc.; N=194 -> 104

Enrollment change • Biosimilar

Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Repros Therapeutics Inc.; Trial completion date: Jan 2014 ->Aug 2014

Trial completion date • Acute Coronary Syndrome • Biosimilar • Chronic Kidney Disease • Heart Failure • Immunology

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) - P1; N=6; Completed; Sponsor: Repros Therapeutics Inc.; Not yet recruiting -> Completed

Trial completion • Biosimilar

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) - P3; N=120; Completed; Sponsor: Repros Therapeutics Inc.; Active, not recruiting -> Completed

Trial completion • Biosimilar

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 (clinicaltrials.gov) - P2; N=45; Recruiting; Sponsor: Repros Therapeutics Inc.

Clinical • New P2 trial

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 (clinicaltrials.gov) - P2; N=50; Active, not recruiting; Sponsor: Repros Therapeutics Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

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 (clinicaltrials.gov) - P2; N=50; Completed; Sponsor: Repros Therapeutics Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion