Hypogonadism
📧 Sign up to get email alerts when something new happens for Hypogonadism.
Sign up freeTop drugs studied for this disease
-
CLINICAL_TRIALS trial_result · 2015-05-27Clinical Trial Update: Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism [Phase 3]
Phase III study evaluating morning testosterone normalization in overweight men with secondary hypogonadism has completed, with results post…
-
FDA label_change · 2015-05-11FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for TESTIM (testosterone gel) from Endo USA, Inc., triggering a change to the product labeling.
-
FDA approval · 2015-05-11FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for TESTOSTERONE from Prasco Laboratories.
-
FDA approval · 2015-05-11FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for testosterone cypionate from Padagis US LLC.
-
FDA approval · 2015-05-11FDA Approved: TESTOPEL — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for TESTOPEL (testosterone) submitted by Endo USA, Inc.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2015-05-11FDA 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.
-
FDA approval · 2015-05-11FDA Approved: NATESTO NASAL GEL — Supplemental Application (Acerus Pharmaceuticals Corporation)
FDA approved a supplemental application for NATESTO NASAL GEL (testosterone) submitted by Acerus Pharmaceuticals Corporation.
-
FDA approval · 2015-05-11FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for AVEED (testosterone undecanoate) submitted by Endo USA, Inc.
-
CLINICAL_TRIALS trial_result · 2015-04-16Clinical Trial Update: Effects of Andriol Testocaps in Symptomatic Late-Onset Hypogonadism (43203) [Phase 2]
This update reports the completion of a Phase 2 trial evaluating Andriol Testocaps for symptomatic late-onset hypogonadism.
-
FDA approval · 2015-04-09FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)
FDA supplemental application for TESTIM (testosterone) filed by Endo USA, Inc. indicates an ongoing regulatory action for the product.
-
CLINICAL_TRIALS withdrawal · 2015-03-31Clinical Trial Update: Testosterone and Pain Sensitivity [Phase 4]
A Phase 4 clinical trial evaluating the relationship between testosterone and pain sensitivity, conducted by Johns Hopkins University, has b…
-
CLINICAL_TRIALS trial_result · 2015-03-26Clinical Trial Update: Leuprolide in Determining the Cause of Gonadotropin Deficiency [NA]
A completed clinical trial investigating the use of leuprolide to determine the cause of gonadotropin deficiency in individuals with hypogon…
-
CLINICAL_TRIALS trial_result · 2015-03-25Clinical Trial Update: Leuprolide in Treating Adults With Hypogonadotropism [NA]
The clinical trial evaluating Leuprolide in adults with hypogonadism has completed, according to the update.
-
CLINICAL_TRIALS trial_result · 2015-03-12Clinical Trial Update: 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 [Phase 1]
This open-label Phase 1 study evaluated the absorption, metabolism, excretion, and mass balance of radiolabeled Androxal given as a single o…
-
FDA approval · 2015-03-03FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)
The FDA approved a supplemental application for GONAL-F (follitropin alfa) by EMD Serono, Inc.
-
FDA approval · 2015-03-03FDA Approved: AVEED — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for AVEED (testosterone undecanoate) from Endo USA, Inc., updating the product labeling.
-
FDA approval · 2015-02-17FDA Approved: TESTOSTERONE CYPIONATE — Supplemental Application (Hospira, Inc.)
FDA approved Hospira's supplemental application for testosterone cypionate, approving a regulatory change to the product.
-
CLINICAL_TRIALS trial_result · 2015-02-16Clinical Trial Update: Investigating the Regulation of Reproductive Hormones in Adult Men [NA]
A NICHD-sponsored clinical trial examining regulation of reproductive hormones in adult men has completed, focusing on Kallmann Syndrome and…
-
CLINICAL_TRIALS withdrawal · 2015-02-13Clinical Trial Update: Does Testosterone Improve Function in Hypogonadal Older Men [Phase 4]
Phase 4 clinical trial evaluating whether testosterone improves function in older men with hypogonadism has been withdrawn. The update notes…
-
CLINICAL_TRIALS trial_result · 2015-01-21Clinical Trial Update: Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes [Phase 2]
Phase 2 trial evaluating the efficacy and safety of AndroGel in men with hypogonadism and type 2 diabetes has completed.
-
CLINICAL_TRIALS trial_result · 2015-01-16Clinical Trial Update: Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism [Phase 2]
This Clinical Trial Update reports the completion of a Phase 2 observational study evaluating T-Gel 1% in adolescent boys with hypogonadism,…
-
FDA approval · 2015-01-12FDA Approved: PREGNYL — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Pregnyl (chorionic gonadotropin alfa) submitted by Organon LLC.
-
CLINICAL_TRIALS trial_result · 2014-12-30Clinical Trial Update: Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism [Phase 3]
A Phase 3 trial evaluating long-term treatment with testosterone undecanoate in males with hypogonadism has completed.
-
CLINICAL_TRIALS trial_result · 2014-12-19Clinical Trial Update: A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels [Phase 2]
A Phase 2 clinical trial evaluating treatment for ejaculatory dysfunction in men with low testosterone has completed and posted results.
-
FDA approval · 2014-11-21FDA Approved: TESTOSTERONE ENANTHATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Testosterone Enanthate from Hikma Pharmaceuticals USA, granting regulatory authorization for thi…