Hypogonadism
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Sign up freeTop drugs studied for this disease
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FDA approval · 2024-07-16FDA Approved: TESTOSTERONE — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for TESTOSTERONE from Strides Pharma Science Limited, authorizing a modified or additional testoster…
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CLINICAL_TRIALS trial_result · 2024-06-28Clinical Trial Update: Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men [Phase 3]
Phase 3 extension trial evaluating ambulatory blood pressure monitoring for oral testosterone undecanoate in hypogonadal men has completed a…
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FDA approval · 2024-06-13FDA Approved: ESTRADIOL — Supplemental Application (NorthStar Rx LLC)
FDA approved a supplemental application for Estradiol (ESTRADIOL) from NorthStar Rx LLC under the ANDA program.
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CLINICAL_TRIALS trial_result · 2024-06-04Clinical Trial Update: Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency [Phase 1, Phase 2]
A Phase 1/2 clinical trial evaluating adipose-derived mesenchymal stem cells for sexual hormone deficiency has completed, with reported outc…
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CLINICAL_TRIALS trial_result · 2024-03-13Clinical Trial Update: A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men [Phase 4]
Phase 4 trial evaluating testosterone replacement therapy for its effect on major adverse cardiovascular events and efficacy in hypogonadal …
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FDA approval · 2024-02-28FDA Approved: TESTOSTERONE ENANTHATE — Original Application (Eugia US LLC)
FDA approved the original application for testosterone enanthate from Eugia US LLC, granting a generic version of this testosterone replacem…
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FDA approval · 2024-02-15FDA Approved: ELESTRIN — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for ELESTRIN (estradiol) from Viatris Specialty LLC. The approval updates the labeling to incorporat…
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CLINICAL_TRIALS trial_result · 2024-02-15Clinical Trial Update: A Randomized, Double-blinded, Clinical, Placebo-controlled Trial on the Effects of Therapy With Letrozole and hUman Choriongonadotropin in Male Hypogonadism Induced by Illicit Use of Anabolic Androgenic Steroids- The LUCAS Trial [Phase 4]
Phase 4 randomized trial assessing letrozole and hCG therapy for male hypogonadism induced by anabolic steroid use; the study status is term…
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FDA approval · 2024-02-07FDA Approved: TESTOSTERONE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for TESTOSTERONE from Actavis Pharma, Inc., updating the approval status of its generic testoste…
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FDA label_change · 2024-02-01FDA Approved: AZMIRO — Supplemental Application (Azurity Pharmaceuticals, Inc.)
FDA approved a supplemental application for AZMIRO (testosterone cypionate) submitted by Azurity Pharmaceuticals, Inc.
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FDA approval · 2023-10-20FDA Approved: TESTOSTERONE CYPIONATE — Original Application (Eugia US LLC)
FDA approved the original application for testosterone cypionate from Eugia US LLC, a generic testosterone replacement therapy. It is indica…
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CLINICAL_TRIALS trial_result · 2023-10-12Clinical Trial Update: Testosterone and Alendronate in Hypogonadal Men [Phase 2]
Phase 2 trial update on testosterone and alendronate in hypogonadal men with osteopenia; study terminated with results posted.
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CLINICAL_TRIALS trial_result · 2023-08-14Clinical Trial Update: Testopel ® vs. Generic Testosterone Pellets. [Phase 3]
A Phase 3 trial comparing Testopel with generic testosterone pellets for hypogonadism has completed, with results posted in 2023.
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FDA approval · 2023-04-13FDA Approved: TESTOSTERONE CYPIONATE — Original Application (NorthStar Rx LLC)
FDA approved the original ANDA for testosterone cypionate, a generic testosterone replacement therapy, from NorthStar Rx LLC.
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CLINICAL_TRIALS trial_result · 2022-12-15Clinical Trial Update: A Study of the Effect of Topical Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism [Phase 4]
Phase 4 trial evaluating the effect of topical testosterone replacement therapy on blood pressure in adult males with hypogonadism; results …
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CLINICAL_TRIALS trial_result · 2022-11-29Clinical Trial Update: Gonadal Dysfunction in Male Long-term Survivors of Malignant Lymphoma; Vitality [Phase 2]
Phase 2 clinical trial assessing gonadal dysfunction treatment in male long-term survivors of malignant lymphoma.
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CLINICAL_TRIALS trial_result · 2022-08-15Clinical Trial Update: Study of DHT-Gel to Treat the Symptoms of Low Testosterone in Men 55-80 [Phase 2]
A Phase 2 trial investigating DHT-Gel for symptoms of low testosterone in men aged 55-80 has completed.
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FDA approval · 2022-07-27FDA Approved: KYZATREX — Original Application (Marius Pharmaceuticals)
FDA approved KYZATREX (testosterone undecanoate) through an Original Application (NDA) by Marius Pharmaceuticals for testosterone replacemen…
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CLINICAL_TRIALS trial_result · 2022-07-12Clinical Trial Update: A Study to Evaluate Androderm®'s Effect on Blood Pressure in Adult Hypogonodal Male Participants [Phase 4]
Phase 4 trial assessing Androderm's effect on blood pressure in adult males with hypogonadism has been completed with results posted.
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CLINICAL_TRIALS trial_result · 2022-07-06Clinical Trial Update: A Study to Monitor Ambulatory Blood Pressure Monitoring in Hypogonadal Men Treated With Nasal Testosterone Gel [Phase 4]
Phase 4 trial update monitoring ambulatory blood pressure in hypogonadal men treated with nasal testosterone gel.
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CLINICAL_TRIALS trial_result · 2022-06-29Clinical Trial Update: Hypogonadotropic Hypogonadism in Obese Young Males [Phase 2]
Phase 2 clinical trial update on hypogonadotropic hypogonadism in obese young males; study terminated with results posted in 2022.
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FDA approval · 2022-06-02FDA Approved: AZMIRO — Original Application (Azurity Pharmaceuticals, Inc.)
FDA approved AZMIRO, an injectable testosterone cypionate product from Azurity Pharmaceuticals, under its original NDA.
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FDA approval · 2022-05-26FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for AVEED (testosterone undecanoate) from Endo USA, Inc. The action updates the drug’s labeling …
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CLINICAL_TRIALS trial_result · 2022-05-18Clinical Trial Update: Testosterone for Peripheral Vascular Disease [Phase 4]
Phase 4 trial update on testosterone for peripheral vascular disease, with results posted after completion.
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FDA approval · 2022-03-28FDA Approved: TLANDO — Original Application (Verity Pharmaceuticals Inc.)
TLANDO (testosterone undecanoate) received FDA approval as a new oral testosterone replacement therapy for adult males with hypogonadism. It…