Clinical trials: Hypogonadotropism
Spinal Cord Injury, Spinal Cord Injuries
Testosterone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial
Spinal cord injury (SCI) results in lower limb muscle loss, bone loss, and high fat mass that impede the recovery of physical function, increase bone fracture risk, and worsen health and quality of life.
- Conditions
- Spinal Cord Injury, Spinal Cord Injuries, Injuries, Spinal Cord, Spinal Cord Contusion
- Trial name
- TRT-SCI (NCT07742553)
- Testing
- testosterone cypionate, finasteride
- Where
- 4 sites in United States
- Volunteers
- 300 people
- Sponsor
- VA Office of Research and Development
Hypogonadism
The Effect of Testosterone Topical Solution (LY900011) in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel
This study will evaluate if testosterone solution can raise testosterone hormone levels into the normal range after treatment for up to 9 Weeks, in those participants with a documented history of subtherapeutic levels [total…
- Trial name
- NCT01893281
- Testing
- Topical Testosterone Solution
- Where
- 21 sites in United States
- Volunteers
- 78 people
- Sponsor
- Eli Lilly and Company
Hypogonadism, Hypogonadism, Male
A Phase 1/2a Study to Determine the Dose Response Pharmacokinetics of TSX-011 (Testosterone Undecanoate) in Hypogonadal Males
This will be a phase 1/2a, open-label, single-center study with 3 periods. The aims of the study are to: 1. evaluate the dose-response curve following ascending single doses of TSX-011; 2. confirm optimum dosing conditions; 3.
- Conditions
- Hypogonadism, Hypogonadism, Male, Gonadal Disorders, Endocrine System Diseases
- Trial name
- NCT03335254
- Testing
- TSX-011
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- TesoRx Pharma, LLC
Nonalcoholic Steatohepatitis, Hypogonadism
Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS)
The main research questions are: In hypogonadal men with non-alcoholic steatohepatitis (NASH), does Testosterone Replacement Therapy (TRT), given for 12 months 1.
- Trial name
- TEREPINS (NCT01919294)
- Testing
- testosterone undecanoate
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
Hypogonadism, Atherosclerosis
Testosterone Replacement in Older Men and Atherosclerosis Progression
As men grow older, their testosterone levels decrease with age. One-third of men, 70 years of age or older, have low testosterone levels.
- Trial name
- TEAAM (NCT00287586)
- Testing
- Testosterone Gel (Androgel)
- Where
- 3 sites in United States
- Volunteers
- 308 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Erectile Disfunction, Hypogonadal Males
Assessment of Effectiveness of Pelvic Floor Muscle Training With Biofeedback in Male With Hypogonadism and Erectile Dysfunction
The goal of this clinical trial is to learn if Pelvic Floor Muscle Training (PFMT) with biofeedback works to treat Erectile Disorders (ED) in males with Functional Hipogonadism. The main hypothesis is: 1.
- Conditions
- Erectile Disfunction, Hypogonadal Males, Functional Hypogonadism, Pelvic Floor Muscle Exercise
- Trial name
- NCT07687173
- Testing
- Training with handheld biofeedback device, Pelvic Floor Muscle Training (PFMT)
- Where
- Poland
- Volunteers
- 120 people
- Sponsor
- Poznan University of Physical Education
Secondary Hypogonadism
Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary…
- Trial name
- NCT00962637
- Testing
- Androxal, AndroGel
- Where
- 18 sites in United States
- Volunteers
- 194 people
- Sponsor
- Repros Therapeutics Inc.
Obesity, Infertility
Reprometabolic Syndrome Mediates Subfertility in Obesity
Obesity plays an adverse role at every stage of conception and pregnancy and mounting evidence implicates relative hypogonadotropic hypogonadism, and reduced menstrual cycle hormone secretion as likely contributors to the…
- Conditions
- Obesity, Infertility, Hypogonadotropic Hypogonadotropism, Hyperinsulinemia
- Trial name
- NCT02653092
- Testing
- Insulin, Intralipid, Dextrose
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Hypogonadism, Paraplegia
Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis
Both conditions hypogonadism and immobilisation (paraplegia) may contribute or lead to decreased bone mineral density resp osteoporosis.
- Conditions
- Hypogonadism, Paraplegia, Bone Density, Osteoporosis
- Trial name
- NCT00838838
- Testing
- Testosterone Undeconate (Nebido-R, BAY86-5037)
- Where
- Germany
- Volunteers
- 26 people
- Sponsor
- Bayer
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
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.
Hypogonadism
Testosterone Replacement in Men With Diabetes and Obesity
The purpose of this study is to examine the effect of having testosterone deficiency in men with diabetes and with obesity. The study will also evaluate the effect of testosterone therapy.
- Trial name
- NCT01127659
- Testing
- testosterone
- Where
- United States
- Volunteers
- 137 people
- Sponsor
- University at Buffalo
Hypogonadism
Efficacy of an Intranasal Testosterone Product
This clinical trial will compare the pharmacokinetic profile of testosterone after repeated intranasal administration of TBS-1 of different strengths in subjects with hypogonadism
- Trial name
- NCT01252745
- Testing
- 10.0 mg of Testosterone, 4.0% TID, 13.5 mg of Testosterone, 4.5% B.I.D, 11.25 mg of Testosterone, 4.5% T.I.D
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- Acerus Pharmaceuticals Corporation
AMH, Hypogonadism, Hypogonadotropic
Hormones in Hypogonadotropic Hypogonadism
Therefore, the main objective of this prospective pilot study is to evaluate a complete hormonal profile in women with hypogonadotropic hypogonadism, including anti-mullerian hormone (AMH) and antral follicle count.
- Conditions
- AMH, Hypogonadism, Hypogonadotropic, Follicle Cyst
- Trial name
- NCT04927676
- Testing
- Blood sample
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Medical University of Vienna
Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
This is a sub-study of Study RM-493-040 (NCT05774756). The goal of this sub-study 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…
- Conditions
- Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form, Septo-Optic Dysplasia, Optic Nerve Hypoplasia
- Trial name
- NCT06760546
- Testing
- Setmelanotide
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 39 people
- Sponsor
- Rhythm Pharmaceuticals, Inc.
Hypogonadism
Evaluation of Testosterone Nasal Gel in Hypogonadal Boys
PK study to evaluate serum levels of testosterone post nasal delivery in two cohorts of hypogonadal boys.
- Trial name
- NCT03345797
- Testing
- Testosterone Nasal Gel [Natesto]
- Where
- 3 sites in United Kingdom
- Volunteers
- 8 people
- Sponsor
- Acerus Biopharma Inc.
Hypogonadism
A Study to Assess the Bioequivalence of Follitropin Alfa Solution in Pen and Follitropin Alfa Powder in Vial in Healthy Downregulated Male Participants
The purpose of this study is to assess the bioequivalence of Test and Reference in healthy downregulated male participants. This is a 2-sequence, 2-period study using the following treatment sequences across Study Periods 1 and…
- Trial name
- NCT07097259
- Testing
- Test: Follitropin alfa, Reference: Follitropin alfa, Zoladex
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Secondary Hypogonadism
Evaluation of the Pharmacokinetics and Safety of Androxal in Male Subjects With Impaired Hepatic Function
To determine and compare the pharmacokinetics (PK) of a single dose of 25 mg Androxal in overweight male subjects with hepatic impairment and in volunteers with normal hepatic function.
- Trial name
- NCT01923870
- Testing
- Androxal 25 mg
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- 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.
Cystic Fibrosis Related Bone Disease
Pilot E2 for Hypogonadal Women With CFBD
The study is a prospective, double blinded, placebo controlled, randomized study to evaluate the effects of daily oral estrogen supplements on bone health, sexual and reproductive health, quality of life and markers of…
- Trial name
- NCT03724955
- Testing
- Estradiol 2 mg
- Where
- United States
- Sponsor
- Emory University