ITT-5 Mechanisms of Spermatogenesis in Man (NCT02147964) | Clinical Trial Compass
WithdrawnPhase 2
ITT-5 Mechanisms of Spermatogenesis in Man
Stopped: No funding was obtained for this study.
United States0Started 2019-06
Plain-language summary
The purpose of this investigational drug study is to determine how much male hormone, testosterone, is needed to maintain sperm production in the testis.
Who can participate
Age range18 Years – 55 Years
SexMALE
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Inclusion Criteria:
* Males age 18-55
* In general good health based on normal screening evaluation
* Normal serum testosterone, lutenizing hormone (LH) and follicle stimulating hormone (FSH)
* Prostate Specific Antigen (PSA) \< 3.0
* Agrees not to donate blood or participate in another research study during the study
* Informed consent
* Must be willing to use a reliable form of contraception during the study
Exclusion Criteria:
* Participation in a long-term male contraceptive study within the past three months
* History of testosterone or anabolic steroid abuse in the past
* History of or current skin disorder that will interfere with testosterone gel
* Poor general health or significantly abnormal screening blood results
* History of or current testicular or prostate disease
* History of a bleeding disorder or need for anticoagulation
* History of untreated sleep apnea and/or major psychiatric problems
* BMI \> 32
* History of or current liver disease
* Chronic pain syndrome
* Current use of terfenidine, astemizole, cisapride, budesonide, felodipine, fluticasone, lovastatin, midazolam, sildenafil, or vardenafil
* Use of glucocorticoids or underlying adrenal insufficiency
* Active drug or alcohol abuse within the past year