Gonadotropin Deficiency Clinical Trial
— ITT-5Official title:
Mechanisms of Hormonal Control of Spermatogenesis in Man
| Verified date | December 2019 |
| Source | University of Washington |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this investigational drug study is to determine how much male hormone, testosterone, is needed to maintain sperm production in the testis.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2026 |
| Est. primary completion date | December 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 55 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Washington Medical Center (Health Sciences) | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| University of Washington |
United States,
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Roth MY, Lin K, Amory JK, Matsumoto AM, Anawalt BD, Snyder CN, Kalhorn TF, Bremner WJ, Page ST. Serum LH correlates highly with intratesticular steroid levels in normal men. J Androl. 2010 Mar-Apr;31(2):138-45. doi: 10.2164/jandrol.109.008391. Epub 2009 Sep 24. — View Citation
Roth MY, Nya-Ngatchou JJ, Lin K, Page ST, Anawalt BD, Matsumoto AM, Marck BT, Bremner WJ, Amory JK. Androgen synthesis in the gonadotropin-suppressed human testes can be markedly suppressed by ketoconazole. J Clin Endocrinol Metab. 2013 Mar;98(3):1198-206. doi: 10.1210/jc.2012-3527. Epub 2013 Jan 24. — View Citation
Roth MY, Page ST, Lin K, Anawalt BD, Matsumoto AM, Snyder CN, Marck BT, Bremner WJ, Amory JK. Dose-dependent increase in intratesticular testosterone by very low-dose human chorionic gonadotropin in normal men with experimental gonadotropin deficiency. J Clin Endocrinol Metab. 2010 Aug;95(8):3806-13. doi: 10.1210/jc.2010-0360. Epub 2010 May 19. — View Citation
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Wu FC, Farley TM, Peregoudov A, Waites GM. Effects of testosterone enanthate in normal men: experience from a multicenter contraceptive efficacy study. World Health Organization Task Force on Methods for the Regulation of Male Fertility. Fertil Steril. 1996 Mar;65(3):626-36. — View Citation
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* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sperm concentration | Difference in sperm concentration at week 16 between 4 treatment groups | 16 weeks | |
| Secondary | IT steroid concentration | It steroid concentration at week 16 between the 4 treatment groups | 16 weeks |