Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy
Completed
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 hypogonadal men during inpatient rehabilitation; (2) Document the natural history of neuroendocrine dysfunction and recovery in men during inpatient rehabilitation after TBI; (3) Obtain data to validate the NIH toolbox, a novel assessment of neurological function for use i... Read More
Gender:
MALE
Ages:
Between 16 years and 65 years
Trial Updated:
07/06/2021
Locations: Craig Hospital, Englewood, Colorado
Conditions: Trauma, Brain Injury, Endocrine Dysfunction
Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men
Completed
The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007.
Gender:
MALE
Ages:
Between 18 years and 75 years
Trial Updated:
06/25/2021
Locations: Alabama Clinical Therapeutics, Inc., Birmingham, Alabama +29 locations
Conditions: Male Hypogonadism
Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men
Completed
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.
Gender:
MALE
Ages:
Between 18 years and 68 years
Trial Updated:
06/23/2021
Locations: Alabama Clinical Therapeutics, Birmingham, Alabama +3 locations
Conditions: Hypogonadism
Ambulatory Blood Pressure Monitoring in Oral Testosterone Undecanoate (TU, LPCN 1021) Treated Hypogonadal Men
Completed
This is an open-label, multi-center, single arm study evaluating the blood pressure (BP) changes from baseline (Visit 3) to post-treatment (Visit 5) assessed by ambulatory blood pressure monitoring (ABPM) in LPCN 1021 treated adult hypogonadal male subjects.
Gender:
MALE
Ages:
Between 18 years and 80 years
Trial Updated:
05/17/2021
Locations: Alabama Clinical Therapeutics, Birmingham, Alabama +15 locations
Conditions: Hypogonadism, Male
Hormones and Decision Making
Completed
An investigation of the neuropsychological processes underlying ethical decision making.
Gender:
MALE
Ages:
Between 18 years and 25 years
Trial Updated:
04/28/2021
Locations: Robert Josephs, Austin, Texas
Conditions: Dyssocial Behavior
Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency
Completed
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.
Gender:
MALE
Ages:
50 years and above
Trial Updated:
04/26/2021
Locations: Urological Sciences Research Foundation, Culver City, California
Conditions: Men With Low Testosterone Levels
Effects of Fast Acting Testosterone Nasal Spray on Anxiety
Completed
The proposed study will test the effects of a fast-acting testosterone nasal spray on the fear reactions of young men to two distinct anxiety challenges (social and nonsocial) using a double-blind randomized experimental design.
Gender:
MALE
Ages:
18 years and above
Trial Updated:
04/26/2021
Locations: University of Texas at Austin Department of Psychology, Austin, Texas
Conditions: Anxiety
Long-term Lifestyle Change and Testosterone Replacement
Completed
Older hypogonadal obese veterans previously participated in a 6 month lifestyle change (diet-induced weight loss and exercise) study with or without testosterone replacement therapy before being followed for the following year at the clinic while receiving standard of care consisting of diet and exercise counseling (for healthy lifestyle change) and testosterone replacement therapy. This study will determine if long-term lifestyle change and testosterone replacement therapy with associated impro... Read More
Gender:
MALE
Ages:
Between 65 years and 85 years
Trial Updated:
03/08/2021
Locations: Michael E DeBakey VA Medical Center, Houston, Texas
Conditions: Hypogonadism, Aging, Overweight and Obesity
Pharmacokinetic Study to Determine Time to Steady-state
Completed
The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.
Gender:
MALE
Ages:
Between 18 years and 75 years
Trial Updated:
12/10/2020
Locations: Alabama Clinical Therapeutics, Birmingham, Alabama
Conditions: Male Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism
Effect of Testosterone Treatment on Embryo Quality
Unknown
The purpose of this study is to determine the effect of treatment with trans-dermal testosterone cream compared to placebo on measures of ovarian reserve, oocyte and embryo quality, and pregnancy rates among women with evidence of diminished ovarian reserve that have persistently low serum testosterone and free testosterone after completing six previous weeks of DHEA supplementation.
Gender:
FEMALE
Ages:
Between 38 years and 44 years
Trial Updated:
11/09/2020
Locations: Center For Human Reproduction, New York, New York +1 locations
Conditions: Primary Ovarian Insufficiency, Female Infertility Due to Diminished Ovarian Reserve
Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation
Completed
The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.
Gender:
MALE
Ages:
Between 18 years and 65 years
Trial Updated:
11/06/2020
Locations: LABiomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California +1 locations
Conditions: Male Hypogonadism
Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance
Completed
Asymptomatic men with progressive metastatic Castration-resistant prostate cancer (CRPC) post- treatment with abiraterone acetate (pre-chemotherapy for metastatic disease) will be treated on a randomized, multi-Institutional open label study to determine if treatment with intramuscular T given on a dose/schedule designed to result in rapid cycling from the polar extremes of supraphysiologic to near castrate levels \[i.e. Bipolar Androgen Therapy (BAT)\] will improve primary and secondary objecti... Read More
Gender:
MALE
Ages:
Between 18 years and 80 years
Trial Updated:
10/09/2020
Locations: Unversity of Alabama, Birmingham, Alabama +16 locations
Conditions: Castration Resistant Metastatic Prostate Cancer