Clinical trials: Hypogonadism
Hypogonadism
Oral Testosterone for the Treatment of Hypogonadism
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors.
- Trial name
- NCT01717768
- Testing
- TSX-002
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- TesoRx Pharma, LLC
Male Hypogonadism
Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
The purpose of this study is to determine the efficacy (based on the pharmacokinetic profile of testosterone) and safety of TBS-1 in the treatment of hypogonadal men
- Trial name
- NCT01446042
- Testing
- Testosterone
- Where
- 30 sites in United States
- Volunteers
- 306 people
- Sponsor
- Acerus Pharmaceuticals Corporation
Hypogonadism
Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
- Trial name
- NCT01104246
- Testing
- Testerone Transdermal System
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Watson Pharmaceuticals
Adult Male Hypogonadism
A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel
This is a multicenter extension trial in adult hypogonadal males. The purpose of this study is to evaluate the safety of testosterone gel delivered using an applicator over an extended period of time.
- Trial name
- NCT01703741
- Testing
- Testosterone Gel (FE 999093)
- Where
- 18 sites in United States, Canada
- Volunteers
- 145 people
- Sponsor
- Ferring Pharmaceuticals
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
Hypogonadism
Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems
Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.
- Trial name
- NCT01323140
- Testing
- testosterone matrix transdermal system
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Watson Pharmaceuticals
Hypogonadism
Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men
The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.
- Trial name
- NCT00695110
- Testing
- Oral testosterone undecanoate (TU) (300 mg T equivalents/dose), Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose), Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food)
- Where
- 4 sites in United States
- Volunteers
- 29 people
- Sponsor
- Clarus Therapeutics, Inc.
Secondary Hypogonadism
The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (<350 ng/dL)after 6 weeks of continuous dosing.
- Trial name
- NCT01386606
- Testing
- Androxal (enclomiphene citrate), Testosterone
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Repros Therapeutics Inc.
Type 2 Diabetes Mellitus, Secondary Hypogonadism
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism
- Trial name
- NCT01191320
- Testing
- Androxal
- Where
- 18 sites in United States
- Volunteers
- 102 people
- Sponsor
- Repros Therapeutics Inc.
Hypogonadism
Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men
Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.
- Trial name
- NCT02697188
- Testing
- Testosterone undecanoate, Testosterone enanthate
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Clarus Therapeutics, Inc.
Adult Male Hypogonadism
A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males
This is a phase 3, open-label, non-randomized, clinical trial to evaluate the efficacy and safety of FE 999303 (Testosterone gel) in adult hypogonadal males.
- Trial name
- NCT02149264
- Testing
- Testosterone gel (FE 999303)
- Where
- 22 sites in United States
- Volunteers
- 160 people
- Sponsor
- Ferring Pharmaceuticals
Hypogonadism, Male
Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).
Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.
- Trial name
- DV (NCT03242590)
- Testing
- LPCN 1021
- Volunteers
- 95 people
- Sponsor
- Lipocine Inc.
Hypogonadotropic Hypogonadism
Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])
Sponsor has decided to discontinue Luveris® in the United States (US) due to level of customer demand for this product, and not due to any efficacy or safety concerns.
- Trial name
- NCT00328926
- Testing
- Luveris® 75 IU, Luveris® 25 IU, Recombinant human follicle stimulating hormone (r-hFSH)
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- EMD Serono
Hypogonadism
Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
Evaluation of safety of a concentration controlled testosterone enanthate QuickShot Testosterone regimen administered subcutaneously once each week to adult males with hypogonadism.
- Trial name
- NCT02504541
- Testing
- Testosterone enanthate auto-injector
- Where
- 20 sites in United States
- Volunteers
- 133 people
- Sponsor
- Antares Pharma Inc.
Secondary Hypogonadism
To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.
- Trial name
- NCT00706719
- Testing
- 25 mg Androxal, Testim 1%
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Repros Therapeutics Inc.
Hypothalamic Obesity
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
The goal of this trial is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with acquired Hypothalamic Obesity (HO).
- Trial name
- NCT05774756
- Testing
- Setmelanotide
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 143 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Hypogonadism
A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations
Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate pharmacokinetics of…
- Trial name
- NCT00857961
- Testing
- Testosterone MD-Lotion
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- Eli Lilly and Company
Hypothalamic Obesity
A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity
The goal of this study was to determine how well LB54640 (also known as bivamelagon) worked and how safe it was in participants with Hypothalamic Obesity (HO).
- Trial name
- NCT06046443
- Testing
- Bivamelagon
- Where
- 10 sites in United States, United Kingdom
- Volunteers
- 28 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Secondary Hypogonadism
Phase III Study to Evaluated Morning Testosterone Normalization in Men With Secondary Hypogonadism
The purpose of ZA-301 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T<300 ng/dL) and normal sperm…
- Trial name
- NCT01532414
- Testing
- Androxal
- Where
- 23 sites in United States
- Volunteers
- 151 people
- Sponsor
- Repros Therapeutics 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