A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%
Completed
This is a Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men with Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment with 12.5 mg or 25 mg Androxal or AndroGel 1.62%.
Gender:
MALE
Ages:
Between 18 years and 60 years
Trial Updated:
09/29/2014
Locations: Not set, Birmingham, Alabama +8 locations
Conditions: Secondary Hypogonadism
A Study of Axiron® in Healthy Participants
Completed
The study involves application of Axiron to each underarm. The study will evaluate the transfer of testosterone from underarms to the clothing items that the participant is wearing and other fabric items washed with participant's' clothes. The study is approximately 6 days, not including screening. Screening is required within 28 days prior to the start of the study.
Gender:
MALE
Ages:
18 years and above
Trial Updated:
07/29/2014
Locations: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Daytona Beach, Florida
Conditions: Healthy Volunteers
Hormone and Information Processing Study
Completed
The purpose of this study is to examine the effects of testosterone (T) replacement on changes in thinking and memory, as well as mood in older men with mild cognitive impairment (MCI) and low T levels. The study will also examine whether taking testosterone has effects on biological markers related to Alzheimer's disease.
Gender:
MALE
Ages:
Between 60 years and 90 years
Trial Updated:
07/10/2014
Locations: VA Puget Sound Health Care Systems, Seattle, Washington
Conditions: Mild Cognitive Impairment, Alzheimer's Disease
Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
Completed
The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.
Gender:
MALE
Ages:
Between 21 years and 65 years
Trial Updated:
06/27/2014
Locations: Paradigm Clinical Inc., Garden Grove, California +17 locations
Conditions: Secondary Hypogonadism
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
Completed
Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.
Gender:
MALE
Ages:
Between 18 years and 65 years
Trial Updated:
06/25/2014
Locations: Phase One Solutions, Inc., Miami Gardens, Florida
Conditions: Primary Hypogonadism, Hypogonadotropic Hypogonadism
Testosterone and Growth Hormone for Bone Loss in Men
Completed
Deficiency of testosterone, growth hormone, or both hormones can result in osteoporosis. If either hormone is replaced, the condition of the bones improves. The purpose of this study is to determine if dual hormone treatment for men deficient in testosterone and growth hormone improves bone structure more than testosterone treatment alone.
Gender:
MALE
Ages:
18 years and above
Trial Updated:
06/12/2014
Locations: Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
Conditions: Hypopituitarism, Hypogonadism, Growth Hormone Deficiency
Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients
Completed
The purpose of this clinical research study is to determine whether the ESTRING or a special preparation of a testosterone cream inserted vaginally are safe for use in breast cancer patients. This study will also evaluate if either of these treatments can improve symptoms of vaginal dryness or decreased sexual interest that are related to your treatment for breast cancer.
Gender:
FEMALE
Ages:
Between 18 years and 80 years
Trial Updated:
05/27/2014
Locations: UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California
Conditions: Sexual Dysfunction, Physiological
Influence of Male Hormones on Regional Fat Metabolism
Completed
The male sex hormone, testosterone, plays an important role in determining body fat distribution in men. This is especially evident in the dramatic shift in body composition as boys and girls reach sexual maturity. Normal weight women have twice the body fat of a normal weight man (30% vs. 15% on average) and men will have twice the stomach fat as women (10% vs. 5% of fat as intra-abdominal, men vs. women). These are likely sex-steroid linked events. Short and long term changes in regional fat d... Read More
Gender:
MALE
Ages:
Between 18 years and 50 years
Trial Updated:
05/13/2014
Locations: Mayo Clinic, Rochester, Minnesota
Conditions: Obesity
Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate Cancer
Terminated
The purpose of this study is to determine whether prostate cancer growth can be slowed in patients who receive Androgel® 1% at 10 gram dose.
Gender:
MALE
Ages:
18 years and above
Trial Updated:
05/12/2014
Locations: University of Southern California, Los Angeles, California +10 locations
Conditions: Prostate Cancer
Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems
Completed
A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms. In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in healthy female subjects with HSDD and maladaptive activity of sexual inhibitory mechanism(s). Sexual satisfaction and other aspects of sexual... Read More
Gender:
FEMALE
Ages:
Between 21 years and 70 years
Trial Updated:
03/28/2014
Locations: San Diego Sexual Medicine, San Diego, California +11 locations
Conditions: Hypoactive Sexual Desire Disorder
ITT4 Intratesticular Hormonal Milieu in Man (ITT4)
Completed
The purpose of this research study is to determine how much male hormone, testosterone, is necessary to maintain sperm production in the testis. This knowledge will be used to help in the development of a safe male hormonal contraception. Specific Aims: 1. to determine if ketoconazole plus acyline will suppress intratesticular testosterone(ITT) to a greater degree than acyline alone. 2. to determine if dutasteride plus acyline will suppress intratesticular dihydrotestosterone (IT-DHT) to a gre... Read More
Gender:
MALE
Ages:
Between 18 years and 50 years
Trial Updated:
03/03/2014
Locations: University of Washington, Seattle, Washington
Conditions: Healthy Males
Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy
Completed
It is well documented that women who have breast cancer may experience a decrease in quality of life and sexual functioning due to side effects from adjuvant endocrine therapy, typically aromatase inhibitors (AIs). Women taking AIs are more likely to report unpleasant urogenital and vaginal symptoms due to the physiologic suppression of estradiol. This treatment can impair sexual functioning and cause a decreased sexual health quality of life. At the present time, there are no Food and Drug Adm... Read More
Gender:
FEMALE
Ages:
50 years and above
Trial Updated:
12/18/2013
Locations: Nebraska Cancer Specialists/Midwest Cancer Center - Legacy, Omaha, Nebraska
Conditions: Breast Cancer, Vaginal Dryness, Dyspareunia, Sexual Health Quality of Life