Clinical trials: Low Testosterone
Male Hypogonadism
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
- Trial name
- NCT01403116
- Testing
- Oral testosterone undecanoate, topical testosterone gel
- Where
- 30 sites in United States, Germany
- Volunteers
- 325 people
- Sponsor
- Clarus Therapeutics, Inc.
Hypogonadism, Opioid-Related Disorders
Clomiphene Citrate for the Treatment of Low Testosterone Associated With Chronic Opioid Pain Medication Administration
The purpose of this randomized controlled clinical trial is to evaluate the effects of clomiphene citrate compared to placebo (substance without active medication) in men who are taking pain medication (opioids) for chronic pain…
- Conditions
- Hypogonadism, Opioid-Related Disorders, Male Infertility
- Trial name
- NCT01880086
- Testing
- Clomiphene citrate
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Weill Medical College of Cornell University
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
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
Testopel ® vs. Generic Testosterone Pellets.
The purpose of this study is to evaluate changes in vascular parameters in subjects receiving Testopel 75mg (one time) versus subjects receiving Compounded Testosterone pellets 100mg (one time) versus subjects receiving…
- Trial name
- NCT04523480
- Testing
- Testopel 75mg Drug Implant, Testopel 100mg Drug Implant, Testopel 200mg Drug Implant
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- University of Miami
Hypogonadotropic Hypogonadism, Low Testosterone
Opioid Antagonism in Hypogonadotropic Hypogonadism
The goal of this study is to evaluate the effects of opioid antagonists on the hypothalamic-pituitary-gonadal axis in subjects with hypogonadotropic hypogonadism (HH).
- Trial name
- NCT04975334
- Testing
- Naloxone
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Stephanie B. Seminara, MD
Bladder Cancer, Low Testosterone Levels
Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer
The purpose of this study is to examine the relationship between testosterone level changes around the time of radical cystectomy.
- Trial name
- NCT03063125
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Kansas Medical Center
Hypogonadism
Cycled Testosterone Replacement Study
The purpose of this study is to determine whether testosterone (male hormone) therapy is effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing in men aged 60 to 85 years.
- Trial name
- NCT00957528
- Testing
- Testosterone
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Aging, Obesity
Effects of Testosterone Gel on Carbohydrate and Lipid Metabolism In Elderly Obese Men
A. HYPOTHESES: In older men low testosterone levels, abdominal obesity and elevated fasting insulin who are at risk for the cardiovascular complications such as heart attack and stroke. 1.
- Conditions
- Aging, Obesity, Insulin Resistance, Hypogonadism
- Trial name
- NCT00365794
- Testing
- Topical testosterone gel 10 g/day
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Mobility Limitation
Optimizing Protein Intake in Older Americans With Mobility Limitations
This will be a randomized, placebo-controlled, parallel group, double blind, clinical trial in community dwelling, older men, 65 years of age or older, who have mobility limitation and low protein intake.
- Trial name
- OPTIMen (NCT01275365)
- Testing
- Testosterone enanthate
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Brigham and Women's Hospital
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.
Heart Failure
Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure
Heart failure (HF) is a complex condition resulting from structural or functional heart diseases that impair the ability of the heart to fill with or pump out blood.
- Trial name
- CORDELIA (NCT00957034)
- Testing
- testosterone
- Where
- 16 sites in United States
- Volunteers
- 17 people
- Sponsor
- Warner Chilcott
Coronary Artery Disease
The Cardiac Benefit of Testosterone Replacement in Men With Low Testosterone Levels With Coronary Artery Disease After Successful Intervention of the Blockage or Narrowed Heart Artery
The purpose of the study is to find out if giving the study drug, Androgel (testosterone) as a testosterone replacement help bring the testosterone to an acceptable level and to find out if it will help improve heart condition in…
- Trial name
- NCT00413244
- Testing
- AndroGel 5 Grams
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Hypogonadism
A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone
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
- NCT00522431
- Testing
- Testosterone
- Volunteers
- 149 people
- Sponsor
- Endo USA Inc., a Keenova Therapeutics Company
Hypogonadism, Male
A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections
The purpose of this study is to evaluate changes in vascular parameters and the prevalence of side effects in subjects receiving 1 cc (200mg) every 2 weeks intramuscular (IM) of Testosterone Cypionate versus subjects receiving…
- Trial name
- NCT04439799
- Testing
- Testosterone Cypionate 200 Mg/ML, Intranasal Testosterone
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- University of Miami
Hypogonadism
A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy
The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with…
- Trial name
- NCT01816295
- Testing
- Testosterone Solution
- Where
- 85 sites in United States, Argentina and 7 more
- Volunteers
- 715 people
- Sponsor
- Eli Lilly and Company
Endocrine Dysfunction, Trauma
Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
The purpose of this study was to address 3 short term objectives; (1) Determine the effects of physiologic testosterone (T) therapy on neurological function and functional independence following traumatic brain injury (TBI) in…
- Conditions
- Endocrine Dysfunction, Trauma, Brain Injury
- Trial name
- NCT01201863
- Testing
- Androgel (Testosterone Gel)
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Craig Hospital
Hypogonadism, Diabetes
Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.
Background: Men≥65 years often produce lower levels of testosterone, meaning there is less testosterone circulating to the tissues of the body.
- Conditions
- Hypogonadism, Diabetes, Sarcopenia, Osteoporosis
- Trial name
- NCT00104572
- Testing
- Androgel (Testosterone Gel), Anastrozole (Aromatase Inhibitor), Calcium Cardone 500mg with vitamin D 400 IU
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- National Institute on Aging (NIA)
Male Hypogonadism
Safety and Efficacy Trial of Testosterone Undecanoate
The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.
- Trial name
- NCT01765179
- Testing
- Oral testosterone undecanoate
- Where
- 27 sites in United States
- Volunteers
- 144 people
- Sponsor
- Clarus Therapeutics, Inc.
Andropause
The Testosterone Trials in Older Men
The Testosterone Trials are a multi-center set of trials involving 12 clinical sites geographically distributed across the United States.
- Trial name
- NCT00799617
- Testing
- AndroGel® (testosterone gel)
- Where
- 12 sites in United States
- Volunteers
- 790 people, healthy volunteers welcome
- Sponsor
- University of Pennsylvania