Treatment Trials

10 Clinical Trials for Various Conditions

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COMPLETED
A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels
Description

The purpose of this study is to see if testosterone solution 2% can impact symptoms of ejaculatory dysfunction in men with low testosterone.

WITHDRAWN
Effect of Testosterone Gel Replacement on Fat Mass in Males With Low Testosterone Levels and Diabetes
Description

The purpose of the study is to find out the effect of replacing testosterone in the form of a gel (Androgel®) on the amount of fat mass in males with low testosterone and diabetes.

COMPLETED
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
Description

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 males with coronary artery disease (CAD) following successful percutaneous coronary intervention.

COMPLETED
Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency
Description

The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels.

COMPLETED
Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer
Description

The purpose of this study is to examine the relationship between testosterone level changes around the time of radical cystectomy.

COMPLETED
Transdermal Testosterone Gel/Effect on Erection Quality as Measured by DIR
Description

Low testosterone may be responsible for "soft" erections in men. The purpose of our study is to see whether the daily application of a testosterone gel to raise testosterone levels will also increase the "hardness" of a man's erection.

Conditions
COMPLETED
A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy
Description

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 low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.

Conditions
COMPLETED
Treatment of Boys With Precocious Puberty
Description

This study is a continuation of two previous studies conducted at the NIH. The first study , "Treatment of True Precocious Puberty with a Long-Acting Lutenizing Hormone Releasing Hormone Analog (D-Trp(6)-Pro(9)-Net-LHRH)" had less than optimal results. Some patients, all of whom were diagnosed with familial isosexual precocious puberty, had an inadequate response to the medication and were observed to have high levels of testosterone, advanced bone aging, and other complications of the disease. As a result these patients were enrolled in a second study In the second study, "Spironolactone Treatment for Boys with Familial Isosexual Precocious Puberty", - the patients received another medication, spironolactone (Aldactone). The drug blocked the effects of testosterone, -but bone age advancement did not improve. Some patients began experiencing gynecomastia (an abnormal growth of the male breasts). Researchers believe these may be the effects of elevated levels of estrodiol (a form of the female hormone, estrogen). In the present study, testolactone is added to the drug regimen to block the production of estrogen. The study therefore uses spironolactone to prevent the action of the male hormones (androgen) and testolactone to block the production of female hormones (estrogen). Deslorelin, an LHRH analog which works by turning off true (central) puberty, is added to the drug regimen once true puberty begins. This is because it is know that boys with familial male precocious puberty go into true puberty too early (despite treatment with spironolactone and testolactone), and when that happens, the spironolactone and testolactone are no longer as effective. The goal of the treatment is to delay sexual development until a more appropriate age and prevent short adult stature (height).

TERMINATED
Testosterone and Cortisol Levels in Infants
Description

Very low birth weight (VLBW) infants have more health and developmental problems than normal birth weight full-term infants. These problems are more common in males than female VLBW preterm infants. Male VLBW infants also experience less positive mother-infant interactions than females, especially when mothers are emotionally distressed. This is a significant problem because positive mother-infant interactions function as an important protective factor against the negative health and developmental outcomes associated with prematurity. The source of the vulnerability of male VLBW infants to health problems, suboptimal mother-infant interactions, and poor development goes beyond gender socialization differences and includes biological factors. Identification of infant and maternal biological markers/predictors of infant health and developmental outcomes could ultimately lead to interventions for VLBW preterm infants. The purpose of this study is to confirm that testosterone rather than cortisol is a more reliable marker/predictor of complications affecting infants' health outcomes, mother-infant interactions, and infant cognitive/motor/language developmental outcomes; and that male infants exhibit a higher sensitivity to testosterone levels than female infants. This longitudinal study will examine the associations of the steroid hormones, testosterone and cortisol, levels with infant health, mother-infant interactions, and infant cognitive/motor/language development ('infant development') in very low birthweight (VLBW, BW \< 1,500 g) preterm (gestational age \< 32 weeks gestation) infants after adjusting for maternal physical and mental health state, infant socioemotional and behavioral development, and characteristics of infants and mothers. Concurrent and repeated measurement of testosterone and cortisol levels both in infants and mothers will be conducted through infancy and early childhood (at birth, 40 weeks postmenstrual age, 12 and 24 months corrected age).

COMPLETED
Evaluation of Prealbumin Levels in Men With Low-T
Description

This is a single-center study intended to evaluate prealbumin (transthyretin), a marker of anabolic metabolism, in men with androgen deficiency (Low-T). There is emerging evidence that prealbumin is an indicator of anabolic, versus catabolic, metabolism, and that lower levels may be associated with hypogonadism.