Clinical trials: Primary Hypogonadism
Hypogonadism, Male
52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism
This is a 52-week open label single arm study + 24-Month long-term safety extension to investigate the effects of XYOSTED, as testosterone replacement therapy, on adolescent males with either primary or secondary hypogonadism.
- Trial name
- NCT06689085
- Testing
- Testosterone enanthate
- Where
- 20 sites in United States
- Volunteers
- 100 people
- Sponsor
- Halozyme Therapeutics
Male Hypogonadism
Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation
The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.
- Trial name
- NCT00924612
- Testing
- Oral testosterone undecanoate (containing 300 mg T)
- Where
- 2 sites in United States, Canada
- Volunteers
- 16 people
- Sponsor
- Clarus Therapeutics, Inc.
Primary or Secondary Hypogonadism, Constitutional Delay in Growth and Puberty (CDGP)
Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism
This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty adolescents. Subjects who complete this trial may enter a 3 month extension study (UMD-01-090E).
- Trial name
- NCT00193661
- Testing
- Testosterone Gel (1%)
- Where
- 19 sites in United States
- Sponsor
- Solvay Pharmaceuticals
Male Hypogonadism
Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism
DITEST is an oral formulation of native testosterone for the treatment of androgen deficiency in men. The study was a Phase 1 clinical study in hypogonadal men, defined according to FDA and Endocrine Society Guidelines, designed…
- Trial name
- NCT02966652
- Testing
- DITEST, Testosterone undecanoate
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- Neurocrine UK Limited
Hypogonadism, Hypogonadism, Male
Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone administered with and without dutasteride
- Trial name
- NCT00400335
- Testing
- Nanomilled testosterone, commercially available dutasteride, Nanomilled dutasteride
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Primary Amenorrhea With Hypogonadotropic Hypogonadism
LutrePulse Hypogonadotropic Hypogonadism
To compare the ovulation rate in women with primary amenorrhea with hypogonadotropic hypogonadism following pulsatile gonadotropin-releasing hormone (GnRH) treatment using the OmniPod pump versus placebo
- Trial name
- NCT01976728
- Testing
- Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump, Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump, Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump
- Where
- 35 sites in United States, Canada
- Volunteers
- 39 people
- Sponsor
- Ferring Pharmaceuticals
Male Hypogonadism, Primary Hypogonadism
Pharmacokinetic Study to Determine Time to Steady-state
The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.
- Conditions
- Male Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
- Trial name
- NCT00911586
- Testing
- Testosterone undecanoate
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Clarus Therapeutics, Inc.
Primary Hypogonadism, Hypogonadotropic Hypogonadism
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.
- Trial name
- NCT02110368
- Testing
- Testosterone Topical Gel, 1.62% Metered Pump, AndroGel (testosterone gel) 1.62% Metered-Dose Pump
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Amneal Pharmaceuticals, LLC
Hypogonadism
A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months
TOL-CLAR-20024 is a Phase 4, multi-center, open-label safety study evaluating the potential effect of JATENZO on adrenal function in hypogonadal men treated with JATENZO for 12 months.
- Trial name
- NCT06385509
- Testing
- Jatenzo Oral Product
- Where
- 27 sites in United States
- Volunteers
- 116 people
- Sponsor
- Tolmar Inc.
Hypogonadism, Primary Hypogonadism
Long-term Safety Study of Intramuscular Injections of 750 mg and 1000 mg Testosterone Undecanoate in Hypogonadal Men
To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone.
- Conditions
- Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
- Trial name
- TU (NCT00467870)
- Testing
- Testosterone Undecanoate 750 mg, Testosterone Undecanoate 1000 mg
- Where
- United States
- Volunteers
- 531 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Hypogonadism
Efficacy and Tolerability of an Intra-Nasal Testosterone Product
This clinical trial is being performed to compare the pharmacokinetic profile of testosterone after repeated intra-nasal administration of products of different strengths in subjects with hypogonadism.
- Trial name
- NCT00975650
- Testing
- Nasobol®, Androderm® (Positive Control)
- Where
- 6 sites in United States
- Volunteers
- 57 people
- Sponsor
- Acerus Pharmaceuticals Corporation
Primary or Secondary Hypogonadism, Constitutional Delay in Growth and Puberty (CDGP)
Pharmacokinetic Evaluation of Testosterone Gel (1%)
Measure and evaluate the level of testosterone in blood, and determine the safety and tolerability following daily applications of testosterone gel.
- Trial name
- NCT00193700
- Testing
- Testosterone Gel (1%)
- Where
- 9 sites in United States
- Sponsor
- Solvay Pharmaceuticals