Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02110368
Other study ID # AL1401
Secondary ID
Status Completed
Phase Phase 3
First received April 8, 2014
Last updated June 25, 2014
Start date March 2014
Est. completion date May 2014

Study information

Verified date June 2014
Source Amneal Pharmaceuticals, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.


Description:

To compare the rate and extent of testosterone absorption for a test formulation of Testosterone Topical Gel, 1.62% Metered Pump, manufactured with that of AndroGel® (testosterone gel) 1.62% Metered-Dose Pump, in normal, healthy, adult, testosterone-deficient (hypogonadal) human male subjects under fasting conditions.


Read more »

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Testosterone Topical Gel, 1.62% Metered Pump

AndroGel (testosterone gel) 1.62% Metered-Dose Pump


Locations

Country Name City State
United States Phase One Solutions, Inc. Miami Gardens Florida

Sponsors (2)

Lead Sponsor Collaborator
Amneal Pharmaceuticals, LLC Phase One Solutions, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary AUC0-t Area under the concentration vs. time curve, from the time of first dosing to the time of the last measured concentration. Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours No
Primary AUC0-inf Area under the concentration vs. time curve, from time of first dosing to infinity Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours No
Primary Cmax Maximum reported concentration. Estimated for both baseline Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours No
Secondary Tmax Time at which Cmax is first observed Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours No
Secondary Kel Apparent first order terminal elimination rate constant determined from the terminal log-linear concentration-time data Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours No
Secondary T 1/2 Terminal elimination half-life Pre-Deose: -1 hour, -0.5 hour and Post-Dose 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 32, 36, 40, 48, and 60 hours No
See also
  Status Clinical Trial Phase
Completed NCT01438073 - Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling Phase 1
Completed NCT01403532 - Sequential Therapy for Hypogonadotropic Hypogonadism Phase 4
Recruiting NCT00456274 - Baselines in Reproductive Disorders N/A
Terminated NCT05205837 - 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
Completed NCT02908074 - A 6 Month Safety Extension Study of MBGS205 Phase 2
Completed NCT05752591 - Hypothalamic-pituitary Dysfunction in Diabetes
Terminated NCT03118479 - Effect of Varying Testosterone Levels on Insulin Sensitivity in Men With Idiopathic Hypogonadotropic Hypogonadism (IHH) Phase 1
Completed NCT02730169 - Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism Phase 2
Recruiting NCT01601171 - Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate
Completed NCT01623570 - Clinical Outcomes in WHO Type I Anovulatory Women Using r-hFSH+r-hLH in a 2:1 Ratio or hMG-HP N/A
Terminated NCT00328926 - Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L]) Phase 4
Completed NCT01438034 - Kisspeptin in the Evaluation of Delayed Puberty Phase 1
Completed NCT04456296 - A Study of the Effect of Testosterone Replacement Therapy on Blood Pressure in Adult Male Participants With Hypogonadism Phase 4
Recruiting NCT00914823 - Kisspeptin Administration in the Adult Phase 1
Terminated NCT01155518 - Hypogonadism in Young Men With Type 2 Diabetes Phase 2
Completed NCT00697814 - Clomiphene in Males With Prolactinomas and Persistent Hypogonadism Phase 2
Active, not recruiting NCT00351416 - Letrozole Treatment in Normal and GnRH Deficient Women Phase 2/Phase 3
Recruiting NCT05971836 - The Molecular Basis of Inherited Reproductive Disorders
Recruiting NCT02705014 - Efficacy of Pulsatile GnRH Therapy on Male Patients With Pituitary Stalk Interruption Syndrome N/A
Recruiting NCT04648969 - Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism Phase 2