Hypogonadism
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Sign up freeTop drugs studied for this disease
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FDA approval · 2014-11-17FDA Approved: TESTOPEL — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for TESTOPEL (testosterone) submitted by Endo USA, Inc.
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FDA approval · 2014-11-14FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for TESTOSTERONE filed by Prasco Laboratories, authorizing changes to the product under the suppleme…
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FDA approval · 2014-11-12FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)
The FDA approved a supplemental application for AndroGel (testosterone) from ASCEND Therapeutics U.S., LLC.
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CLINICAL_TRIALS trial_result · 2014-11-05Clinical Trial Update: NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH) [Phase 4]
A Phase 4 trial of Nebido (testosterone undecanoate) for symptomatic late onset hypogonadism has been terminated.
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CLINICAL_TRIALS trial_result · 2014-10-28Clinical Trial Update: Testosterone Replacement in Metabolic Syndrome and Inflammation [Phase 4]
Phase 4 clinical trial evaluating testosterone replacement in men with hypogonadism and metabolic syndrome, with related obesity and erectil…
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CLINICAL_TRIALS trial_result · 2014-10-27Clinical Trial Update: The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel [Phase 4]
This Phase 4 trial investigated a testosterone topical solution (LY900011) in hypogonadal men with suboptimal response to a testosterone gel…
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CLINICAL_TRIALS trial_result · 2014-10-01Clinical Trial Update: Assessment of the Effects of Enclomiphene Citrate on Bone Mineral Density in Men With Secondary Hypogonadism [Phase 3]
Phase 3 study assessing the effect of enclomiphene citrate on bone mineral density in men with secondary hypogonadism; the trial status is c…
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CLINICAL_TRIALS trial_result · 2014-10-01Clinical Trial Update: 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]
Phase III randomized, double-blind, placebo-controlled study in men with acquired hypogonadotropic hypogonadism comparing 12.5 mg or 25 mg e…
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CLINICAL_TRIALS trial_result · 2014-08-11Clinical Trial Update: Evaluation of Pharmacokinetic and Safety Profile of Androxal in Male Subjects With Impaired Renal Function [Phase 1]
Phase 1 study evaluating the pharmacokinetic profile and safety of Androxal in male subjects with impaired renal function has completed.
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CLINICAL_TRIALS trial_result · 2014-07-28Clinical Trial Update: Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism [Phase 2]
Phase 2 clinical trial results show normalization of morning testosterone levels in men with secondary hypogonadism.
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CLINICAL_TRIALS trial_result · 2014-07-24Clinical Trial Update: Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism [Phase 3]
Phase 3 safety study of enclomiphene citrate in men with secondary hypogonadism has completed and results have been posted.
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CLINICAL_TRIALS trial_result · 2014-07-01Clinical Trial Update: Reandron in Diabetic Men Witn Low Testosterone Level [Phase 2, Phase 3]
Clinical trial update for Reandron in men with type 2 diabetes and hypogonadism; Phase 2/3 study has completed.
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CLINICAL_TRIALS trial_result · 2014-06-27Clinical Trial Update: Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism [Phase 3]
Phase 3 study evaluating the safety and efficacy of Androxal in men with secondary hypogonadism has completed; no detailed results are provi…
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CLINICAL_TRIALS trial_result · 2014-06-26Clinical Trial Update: Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions [Phase 3]
A Phase 3 bioequivalence study comparing test and reference testosterone topical gel 1.62% in hypogonadal men has completed.
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FDA approval · 2014-06-19FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for TESTOSTERONE from Prasco Laboratories.
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FDA approval · 2014-06-19FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)
The FDA approved a supplemental application for ANDROGEL (testosterone) submitted by ASCEND Therapeutics U.S., LLC.
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FDA approval · 2014-06-19FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for TESTOSTERONE CYPIONATE from Padagis US LLC.
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FDA approval · 2014-06-19FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Sun Pharmaceutical's testosterone cypionate, enabling the generic product to be marketed for its…
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FDA approval · 2014-06-19FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for AVEED (testosterone undecanoate) from Endo USA, Inc. This action indicates an update to the …
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FDA approval · 2014-06-19FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Hospira, Inc.)
The FDA approved a supplemental application for Hospira's testosterone cypionate, indicating regulatory approval of a modification to the ap…
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CLINICAL_TRIALS trial_result · 2014-06-13Clinical Trial Update: Testosterone and Growth Hormone for Bone Loss in Men [Phase 2]
Phase 2 clinical trial evaluating testosterone and growth hormone (somatropin) for bone loss in men with hypopituitarism or related hormone …
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FDA approval · 2014-06-04FDA Approved: VOGELXO — Original Application (Upsher-Smith Laboratories, LLC)
The FDA approved Vogelxo (testosterone) through an Original Application NDA filed by Upsher-Smith Laboratories. It is intended as testostero…
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CLINICAL_TRIALS withdrawal · 2014-06-02Clinical Trial Update: An Efficacy and Safety Study of ABT-SLV176 for the Treatment of Hypogonadal Men [Phase 3]
Phase 3 trial evaluating ABT-SLV176 for the treatment of hypogonadism/testosterone deficiency has been withdrawn.
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FDA approval · 2014-05-28FDA Approved: NATESTO NASAL GEL — Original Application (Acerus Pharmaceuticals Corporation)
The FDA approved NATESTO nasal gel (testosterone) through an original application for testosterone replacement therapy in adult males with l…
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FDA label_change · 2014-05-01FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for TESTIM (testosterone gel) by Endo USA, Inc., resulting in updated labeling for the product.