ITT-5 Mechanisms of Spermatogenesis in Man

• Status: Withdrawn
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Treatments: Acyline; Chorionic Gonadotropin; Dutasteride; Ketoconazole; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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