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 · 2014-04-16Clinical Trial Update: An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism [Phase 3]
This entry reports the completion of a Phase 3 extension study evaluating enclomiphene citrate for men with secondary hypogonadism.
-
CLINICAL_TRIALS trial_result · 2014-04-14Clinical Trial Update: Visceral Adiposity Index and Triglyceride/High-density Lipoprotein Cholesterol Ratio in the Congenital Hypogonadotropic Hypogonadism and Effect of Testosteron Treatment [Phase 4]
Phase 4 trial update assesses the effects of testosterone treatment on visceral adiposity index and triglyceride-to-HDL cholesterol ratio in…
-
CLINICAL_TRIALS trial_result · 2014-04-11Clinical Trial Update: The Effect of Testosteron Replacement Treatment on the Fibroblast Growth Factor-23, Asymmetric Dimethylarginine and Vitamin D Levels in the Congenital Hypogonadotropic Hypogonadism [Phase 4]
This Phase 4 trial examines the effects of testosterone replacement therapy on FGF-23, asymmetric dimethylarginine, and vitamin D levels in …
-
CLINICAL_TRIALS trial_result · 2014-04-07Clinical Trial Update: Testosterone Replacement Therapy in Chronic Spinal Cord Injury [Phase 2, Phase 3]
Completed Phase 2 and Phase 3 trial results on testosterone replacement therapy for individuals with chronic spinal cord injury and hypogona…
-
CLINICAL_TRIALS trial_result · 2014-03-07Clinical Trial Update: A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone [Phase 3]
Phase 3 trial in males with low testosterone completed; results posted in 2014.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2014-03-05FDA Approved: AVEED — Original Application (Endo USA, Inc.)
The FDA approved AVEED (testosterone undecanoate) from Endo USA, Inc. through an original application for testosterone replacement therapy i…
-
FDA approval · 2014-02-28FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for TESTOSTERONE submitted by Prasco Laboratories.
-
FDA approval · 2014-02-27FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)
FDA approved a supplemental application for AndroGel (testosterone) submitted by ASCEND Therapeutics U.S., LLC.
-
CLINICAL_TRIALS research · 2014-02-10Clinical Trial Update: Estrogen Dosing in Turner Syndrome: Pharmacology and Metabolism [Phase 4]
Phase 4 clinical trial updating estrogen dosing, pharmacology, and metabolism in Turner syndrome with hypogonadism.
-
FDA label_change · 2014-01-30FDA Approved: GONAL-F — Supplemental Application (EMD Serono, Inc.)
FDA approved a supplemental application for GONAL-F (follitropin alfa) to update labeling and/or indications under the existing license.
-
CLINICAL_TRIALS trial_result · 2014-01-24Clinical Trial Update: Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function [Phase 1]
Phase 1 pharmacokinetic and safety evaluation of Androxal in male subjects with impaired hepatic function completed.
-
FDA approval · 2014-01-02FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)
The FDA has approved a supplemental application for TESTIM (testosterone gel) submitted by Endo USA, Inc. The approval covers changes reques…
-
CLINICAL_TRIALS trial_result · 2013-11-14Clinical Trial Update: Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) [Phase 4]
A Phase 4 clinical trial update reports completed evaluation of testosterone therapy in men with type 2 diabetes mellitus and hypogonadism.
-
FDA approval · 2013-08-30FDA Approved: TESTIM — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for TESTIM (testosterone) by Endo USA, Inc. The action updates the regulatory status of the testoste…
-
CLINICAL_TRIALS trial_result · 2013-07-26Clinical Trial Update: Comparison of Salivary and Serum Free Testosterone in Normal and Hypogonadal Men
Clinical trial update comparing salivary versus serum free testosterone in normal and hypogonadal men; the current status is unknown.
-
CLINICAL_TRIALS trial_result · 2013-06-21Clinical Trial Update: Efficacy and Tolerability of Testogel/Nebido in Combination With Exercise and Diet in Hypogonadal Male Patients
A completed clinical trial evaluating the efficacy and tolerability of Testogel and Nebido in combination with exercise and diet for hypogon…
-
FDA approval · 2013-06-03FDA Approved: TESTOSTERONE CYPIONATE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's testosterone cypionate under an Original Application (ANDA201720) for a generic testosterone replacement t…
-
FDA approval · 2013-05-20FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for TESTOSTERONE (Prasco Laboratories). This action updates the product labeling.
-
FDA approval · 2013-05-20FDA Approved: ANDROGEL — Supplemental Application (ASCEND Therapeutics U.S., LLC)
FDA approved a supplemental application for ANDROGEL (testosterone gel) submitted by ASCEND Therapeutics U.S., LLC. The action updates the p…
-
CLINICAL_TRIALS trial_result · 2013-05-17Clinical Trial Update: A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203 [Phase 2]
One-year open-label follow-up study to treat hypogonadism in men who completed ZA-203; the trial is in Phase 2 and has completed.
-
CLINICAL_TRIALS trial_result · 2013-05-01Clinical Trial Update: TDSM- Testosterone Dose Response in Surgically Menopausal Women [NA]
The document reports that the clinical trial NCT00494208, studying testosterone dose response in surgically menopausal women, has completed.
-
FDA approval · 2013-04-04FDA Approved: GONAL-F RFF REDI-JECT — Supplemental Application (EMD Serono, Inc.)
FDA approved a supplemental application for GONAL-F RFF REDI-JECT (follitropin) related to its REDI-JECT delivery system, expanding the appr…
-
FDA approval · 2013-03-13FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for TESTOSTERONE by Prasco Laboratories.
-
FDA approval · 2013-03-12FDA Approved: TESTOSTERONE — Supplemental Application (Prasco Laboratories)
FDA granted supplemental approval for TESTOSTERONE by Prasco Laboratories, enabling updated labeling for the testosterone product.
-
CLINICAL_TRIALS trial_result · 2013-02-26Clinical Trial Update: Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement [Phase 4]
A Phase 4 clinical trial update reports an efficacy study evaluating the combination of dutasteride with testosterone replacement therapy in…