Hypogonadism
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CLINICAL_TRIALS trial_result · 2007-11-07Clinical Trial Update: Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate [Phase 4]
A Phase 4 clinical trial update evaluating testosterone undecanoate for erectile dysfunction in men with hypogonadism. The current status of…
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FDA approval · 2007-10-11FDA Approved: DELESTROGEN — Supplemental Application (Par Health USA, LLC)
The FDA approved a supplemental application for Delestrogen (estradiol valerate) from Par Health USA, LLC, resulting in updated labeling for…
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FDA approval · 2007-05-23FDA Approved: TESTOSTERONE — Original Application (Strides Pharma Science Limited)
The FDA approved Strides Pharma Science Limited's original ANDA for a generic testosterone product, establishing a generic option for testos…
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CLINICAL_TRIALS trial_result · 2007-03-27Clinical Trial Update: Safety of Testosterone Undecanoate i.m. in Hypogonadal Men [Phase 2]
Phase 2 clinical trial update evaluating the safety of intramuscular testosterone undecanoate in men with hypogonadism.
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CLINICAL_TRIALS trial_result · 2006-12-25Clinical Trial Update: Pharmacokinetic Evaluation of Testosterone Gel (1%) [Phase 1]
Phase 1 pharmacokinetic evaluation of testosterone gel 1% in individuals with primary or secondary hypogonadism and constitutional delay in …
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FDA approval · 2006-12-15FDA Approved: ELESTRIN — Original Application (Viatris Specialty LLC)
FDA approved ELESTRIN (estradiol) via an original NDA; indicates estrogen replacement therapy for menopausal symptoms and related indication…
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CLINICAL_TRIALS research · 2006-10-04Clinical Trial Update: Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial [Phase 4]
A Phase 4 randomized, double-blind trial evaluating testosterone replacement in middle-aged hypogonadal men with dysthymia; the current stat…
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FDA label_change · 2006-07-14FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)
Supplemental FDA submission for ANDROGEL (testosterone) by ASCEND Therapeutics U.S., LLC. The filing appears to involve labeling changes to …
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CLINICAL_TRIALS research · 2006-05-15Clinical Trial Update: Three-Year Trial on a New Testosterone Gel [Phase 3]
This entry reports a three-year Phase 3 clinical trial evaluating a new testosterone gel for hypogonadism.