Hypogonadism
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-05-10FDA Approved: TESTOSTERONE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)
The FDA approved a supplemental application for a testosterone product from Padagis Israel Pharmaceuticals Ltd (ANDA204255).
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FDA approval · 2019-05-10FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)
FDA approved a supplemental application for ANDROGEL (testosterone) from ASCEND Therapeutics U.S., LLC.
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FDA approval · 2019-05-10FDA Approved: TESTOSTERONE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for TESTOSTERONE from Lupin Pharmaceuticals, Inc., updating the approved product labeling.
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FDA approval · 2019-05-10FDA Approved: TESTOSTERONE — Supplemental Application (Cipla USA Inc.)
The FDA approved a supplemental application for TESTOSTERONE from Cipla USA Inc., updating an already approved testosterone product. The app…
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FDA approval · 2019-04-24FDA Approved: TESTOSTERONE CYPIONATE — Original Application (Wilshire Pharmaceuticals)
FDA approved Wilshire Pharmaceuticals' original application for testosterone cypionate, establishing a generic option for testosterone repla…
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CLINICAL_TRIALS trial_result · 2019-04-19Clinical Trial Update: Pharmacokinetic Study of Subcutaneous Testosterone Enanthate [Phase 1]
Phase 1 pharmacokinetic study of subcutaneous testosterone enanthate in hypogonadism completed.
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FDA approval · 2019-04-10FDA Approved: TESTOSTERONE — Original Application (Actavis Pharma, Inc.)
FDA approved Actavis Pharma, Inc.'s TESTOSTERONE as a generic product under an Original Application (ANDA 204570). It is indicated for testo…
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FDA approval · 2019-04-10FDA Approved: TESTOSTERONE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved Amneal Pharmaceuticals NY LLC's original application for a generic testosterone product. This approval provides a generic optio…
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CLINICAL_TRIALS trial_result · 2019-04-04Clinical Trial Update: Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism [Phase 4]
A Phase 4 clinical trial investigating the effect of testosterone on endothelial function and microcirculation in men with type 2 diabetes a…
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FDA approval · 2019-03-27FDA Approved: JATENZO — Original Application (TOLMAR Inc.)
FDA approved JATENZO (testosterone undecanoate) from Tolmar Inc. as an original NDA for testosterone replacement therapy in adult men with h…
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CLINICAL_TRIALS research · 2019-03-05Clinical Trial Update: CYP19A1 (Cytochrome P450 Family 19 Subfamily A Member 1) Gene and Pharmacogenetics of Response to Testosterone Therapy [Phase 1]
Phase 1 trial exploring CYP19A1 gene pharmacogenetics and response to testosterone therapy in hypogonadism.
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FDA label_change · 2019-02-25FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)
FDA approved a supplemental application for ANDROGEL (testosterone) submitted by ASCEND Therapeutics U.S., LLC.
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FDA approval · 2019-02-25FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for TESTOSTERONE submitted by Prasco Laboratories. The action updates the regulatory status of this …
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CLINICAL_TRIALS other · 2019-01-25Clinical Trial Update: Hormonal Predictors of Oncologic Surgery
Clinical trial update indicating the study on hormonal predictors of oncologic surgery has completed.
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FDA approval · 2019-01-04FDA Approved: ESTRADIOL — Supplemental Application (PURACAP LABORATORIES, LLC)
The FDA granted approval for a supplemental application for Estradiol submitted by Puracap Laboratories, LLC, approving changes to an Estrad…
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FDA approval · 2018-12-19FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for AVEED (testosterone undecanoate) from Endo USA, Inc.
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CLINICAL_TRIALS trial_result · 2018-11-01Clinical Trial Update: Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men [Phase 2]
Pilot pharmacokinetic study of oral testosterone ester formulations in men with hypogonadism completed; results posted.
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FDA approval · 2018-09-01FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for AVEED (testosterone undecanoate) submitted by Endo USA, Inc.
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CLINICAL_TRIALS trial_result · 2018-08-17Clinical Trial Update: Effects of Replacement Therapy With Sexual Steroid Hormones on the Insulin Sensitivity of Hypogonadal Man [Phase 3]
Phase 3 trial assessing replacement therapy with sexual steroid hormones and its effect on insulin sensitivity in hypogonadal men; study com…
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CLINICAL_TRIALS trial_result · 2018-08-13Clinical Trial Update: Efficacy and Tolerability of an Intra-Nasal Testosterone Product [Phase 2]
Phase 2 trial update on efficacy and tolerability of an intra-nasal testosterone product for hypogonadism; results posted after completion.
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CLINICAL_TRIALS trial_result · 2018-08-07Clinical Trial Update: Testosterone Replacement Therapy and Liraglutide Effects on Weight Loss in Hypogonadism. [Phase 4]
A Phase 4 study evaluating testosterone replacement therapy and liraglutide effects on weight loss in men with hypogonadism and obesity has …
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FDA approval · 2018-08-01FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Hospira, Inc.)
The FDA approved Hospira's supplemental application for testosterone cypionate, a generic testosterone replacement therapy.
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CLINICAL_TRIALS trial_result · 2018-07-13Clinical Trial Update: Evaluation of Prealbumin Levels in Men With Low-T
This update reports the completion of a clinical trial evaluating prealbumin levels in men with testosterone deficiency.
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FDA approval · 2018-06-19FDA Approved: TESTOSTERONE CYPIONATE — Original Application (Cipla USA Inc.)
FDA approved the generic testosterone cypionate (ANDA210362) from Cipla USA Inc. under an Original Application for testosterone replacement …
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CLINICAL_TRIALS trial_result · 2018-05-18Clinical Trial Update: The Efficacy of Fenugreek Supplementation on Men's Health [NA]
A completed clinical trial evaluated fenugreek supplementation for aging-related health and testosterone deficiency symptoms in men.