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17 Hypogonadism Trials
Power is an online platform that helps thousands of Hypogonadism patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Hormone Therapy for Musculoskeletal Health
Pittsburgh, PennsylvaniaNon-combat-related muscle, tendon and bone injuries are the most common injuries suffered by military personnel, particularly in new recruits. These injuries impact military readiness and are responsible for roughly 60% of limited duty days, 65% of soldiers who are unable to deploy, and nearly $500 million in medical cost to the government annually in the Army alone. Drug interventions must be studied and developed to prevent these negative outcomes and prepare military personnel for the demands of military service. At the current time, military leadership has identified critical gaps in understanding how to minimize these injuries and train soldiers with drug intervention serving among those gaps.
The goal of this study is to determine how a hormonal intervention can change muscle, tendon, and bone function as well as physical and psychological performance in response to mental and physical stress. To do so, we will examine sex hormone (testosterone, estrogen) levels, muscle, tendon, and bone images, blood samples, and physical and mental performance. We will look at things like changes in hormone levels, chemicals released from active skeletal muscles, and your body composition. The results from this study will be used to improve physical readiness training in the military with the goal of reducing injuries.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 40
Sex:All
Key Eligibility Criteria
Disqualifiers:Heart Condition, Hypertension, Diabetes, Others
Must Not Be Taking:Estrogens, Androgens, Bisphosphonates, Others
120 Participants Needed
Jatenzo for Low Testosterone
Statesville, North CarolinaTOL-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.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18 - 65
Sex:Male
110 Participants Needed
Testosterone Gel for Cancer-Related Fatigue
Richmond, VirginiaThis is a large randomized, double-blind, placebo-controlled trial to determine the efficacy of testosterone replacement on cancer-related fatigue in older men with solid or hematologic (blood) cancer who report fatigue and have low testosterone levels.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:55+
Sex:Male
Key Eligibility Criteria
Disqualifiers:Prostate Cancer, Sleep Apnea, Others
Must Not Be Taking:Anabolic Agents
230 Participants Needed
Testosterone Treatment for Chronic Kidney Disease
Saint Louis, MissouriThis study in being conducted in men who have low testosterone and chronic kidney disease. The investigators will evaluate the effects of an oral testosterone preparation, JATENZO, on testosterone levels and hemoglobin (red blood cells).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 85
Sex:Male
Key Eligibility Criteria
Disqualifiers:Heart Failure, Prostate Cancer, HIV, Others
Must Not Be Taking:TRT, ESA, Warfarin, DHEA
20 Participants Needed
Testosterone Replacement Therapy for Low Testosterone
Atlanta, GeorgiaThis trial tests if giving testosterone to men with low levels can help them recover better from major urologic surgery by making them stronger and healthier. Testosterone therapy has been studied extensively and shown to improve various health outcomes in men with low testosterone levels, including muscle mass, bone density, libido, stamina, and cognition.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:Male
Key Eligibility Criteria
Disqualifiers:Prostatectomy, Orchiectomy, Pituitary Disorders, Others
Must Not Be Taking:Anabolic Steroids
100 Participants Needed
Subcutaneous Kisspeptin for Hypogonadotropic Hypogonadism
Boston, MassachusettsThe goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in men and women with idiopathic hypogonadotropic hypogonadism (IHH). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered SC for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth (for women) and frequent blood sampling (every 10 minutes for up to 70 minutes) will be performed to assess the physiologic response to kisspeptin over time.
Funding Source: FDA OOPD
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Excessive Alcohol, Illicit Drugs, Pregnancy, Others
Must Not Be Taking:Hormonal Replacements
36 Participants Needed
Opioid Antagonist Therapy for Low Testosterone
Boston, MassachusettsThis trial uses hormone injections and naloxone to study their effects on people with low reproductive hormone levels due to an unknown cause. Kisspeptin and GnRH help increase hormone production, while naloxone blocks opioid effects. The goal is to understand how these treatments affect hormone levels in these patients.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Age:18 - 75
Sex:All
23 Participants Needed
Testosterone Therapy for Low Testosterone
Boston, MassachusettsThe aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, fatigue, and quality of life when compared with placebo in men with chronic spinal pain treated with opioids who have opioid-induced hypogonadism (low testosterone).
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:Male
Key Eligibility Criteria
Disqualifiers:Prostate Cancer, Organic Hypogonadism, Bipolar, Others
Must Be Taking:Opioid Analgesics
150 Participants Needed
Kisspeptin for Low Testosterone
Boston, MassachusettsThe goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Illicit Drugs, Excessive Alcohol, Others
Must Be Taking:Reproductive Condition Treatments
24 Participants Needed
Subcutaneous Kisspeptin for Fertility Issues
Boston, MassachusettsThe goal of this study is to see whether kisspeptin, a naturally occurring hormone, can stimulate the release of other reproductive hormones in women with hypothalamic amenorrhea (HA). The investigators are also examining whether kisspeptin can help women release eggs from their ovaries. Kisspeptin will be administered subcutaneously (SC) for two weeks in a pulsatile fashion. Ultrasound monitoring of ovarian follicular growth and frequent blood sampling (every 10 minutes for up to two hours) will be performed to assess the physiologic response to kisspeptin over time.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Breastfeeding, Oophorectomy, Others
Must Not Be Taking:Hormonal Replacements
50 Participants Needed
Testosterone Replacement for Fatigue in Male Cancer Survivors
Boston, MassachusettsThis trial is testing a testosterone drug to help young male cancer survivors who feel very tired and have low testosterone. The drug aims to increase their energy, improve sexual function, and make them stronger.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 54
Sex:Male
Key Eligibility Criteria
Disqualifiers:Hormone-dependent Cancers, Brain Cancer, Others
Must Not Be Taking:Anabolic Agents, Glucocorticoids
240 Participants Needed
Locomotor Training + Testosterone for Spinal Cord Injury
Jacksonville, FloridaThis pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:Male
Key Eligibility Criteria
Disqualifiers:Cancer, Cardiovascular Events, Neurologic Impairments, Others
Must Not Be Taking:Anticoagulants, Opioids, Glucocorticoids, Others
21 Participants Needed
Testosterone Therapy for Low Testosterone and Diabetes
Houston, TexasLow testosterone and diabetes mellitus are each associated with increased risk for fractures. Men with diabetes mellitus are commonly found to have low testosterone as well. Testosterone has been shown to improve the bone health of patients with low testosterone but has not been tested in patients who also have diabetes mellitus in addition to low testosterone. To date, there is no treatment that is specifically recommended for bone disease among patients with diabetes. This study will evaluate the effect of testosterone on the bone health of male Veterans who have both diabetes and low testosterone, both of which are highly prevalent in this subset of the population.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:35 - 70
Sex:Male
92 Participants Needed
Anastrozole for Obesity and Low Testosterone
Houston, TexasThe investigators have preliminary data suggesting that obese patients with hypogonadotropic hypogonadism (HHG) have minimal benefit from testosterone therapy likely because of its conversion to estradiol by the abundant aromatase enzyme in the adipocytes. The increased conversion of androgens into estrogens in obese men results in a negative feedback of high estradiol levels on hypothalamus and pituitary, inhibiting the production of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and follicle stimulating hormone (FSH) and, as a consequence, of testosterone by the testis. Testosterone administration could increase estradiol production, further promoting the inhibitory feedback to the hypothalamic-pituitary-gonadal axis. Although weight loss from lifestyle modification has been shown to reduce estradiol and increase testosterone levels, the effect is at best modest and weight regain results in recurrence of hypogonadism. The use of aromatase inhibitors, in combination with weight loss, could be an effective alternative strategy due to its action at the pathophysiology of the disease.
Intervention Subjects (body mass index of ≥35, testosterone \<300 ng/dl) will be randomized to the active (anastrozole) or control (placebo) group. Anastrozole 1 mg tablet / day will be self-administered with or without food, at around the same time every day (active group); placebo 1 tablet/day with or without food to take at around the same time every day (control group). The study duration will be 12 months.
Both groups will undergo lifestyle intervention consisting of diet and supervised exercise program. Target weight loss will be at least 10% of baseline body weight during the intervention. Subjects will attend weekly group behavior modification sessions which will last \~75-90 min for the first 3 months and decreased to every two weeks from 3 to 12 months. Subjects will attend supervised research center-based exercise sessions during the first 6 months followed by community fitness center-based sessions during the next 6 months for at least 2 d/wk, with recording of home-based exercises for the other 2-4 days/week.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:35 - 65
Sex:Male
Key Eligibility Criteria
Disqualifiers:Diabetes, Prostate Carcinoma, Others
Must Not Be Taking:Bisphosphonates, Glucocorticoids, Others
120 Participants Needed
Controlled Diet for Reproductive Hormone Levels
Aurora, ColoradoThe purpose of this study is to learn more about reproductive hormones and if they change in response to 5-days eating an individualized, standardized diet at two levels: energy balance and low energy intake.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 30
Sex:Female
25 Participants Needed
Testosterone Replacement for Hypogonadism
El Paso, TexasThis is a 52-week open label single arm study to investigate the effects of XYOSTED, as testosterone replacement therapy, on adolescent males with either primary or secondary hypogonadism.
The study aims to determine the effectiveness of XYOSTED measured by continuation or induction of puberty in addition to XYOSTED dosage, safety and testosterone levels.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 17
Sex:Male
Key Eligibility Criteria
Disqualifiers:Thyroid Dysfunction, Hypertension, Tumors, Others
Must Be Taking:Testosterone
100 Participants Needed
PDE5 Inhibitor + Testosterone Therapy for Erectile Dysfunction
Newport Beach, CaliforniaTo assess endothelial dysfunction in young men (aged 30-50) with vasculogenic ED identified through penile Doppler ultrasound.
To evaluate changes in endothelial function using EndoPAT before and 3-6 months after daily low-dose phosphodiesterase type 5 (PDE5) inhibitor therapy.
To investigate endothelial function alterations in hypogonadal patients before and 3-6 months after initiating testosterone (T) therapy
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18+
Sex:Male
120 Participants Needed
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Frequently Asked Questions
How much do Hypogonadism clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Hypogonadism clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Hypogonadism trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Hypogonadism is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Hypogonadism medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Hypogonadism clinical trials ?
Most recently, we added Opioid Antagonist Therapy for Low Testosterone, Testosterone Replacement for Hypogonadism and PDE5 Inhibitor + Testosterone Therapy for Erectile Dysfunction to the Power online platform.