ITT-5 Mechanisms of Spermatogenesis in Man

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Gonadotropin Deficiency

In brief

The purpose of this investigational drug study is to determine how much male hormone, testosterone, is needed to maintain sperm production in the testis.

Key facts

Study ID

NCT02147964

Run by

University of Washington

People needed

0

Starts

2019-06-01

Expected to finish

2026-12-01

Last updated by the study team

2019-12-18

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Washington Medical Center (Health Sciences) — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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