ITT-5 Mechanisms of Spermatogenesis in Man

Phase 2

Withdrawn

• Conditions: Gonadotropin Deficiency
• Interventions: Drug: Testosterone 1% Gel; Drug: Acyline; Drug: HCG; Drug: placebo dutasteride; Drug: Ketoconazole; Drug: Dutasteride; Drug: placebo ketoconazole

• Registration Number: NCT02147964
• Lead Sponsor: University of Washington

Brief 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.

Detailed Description

This is a nine-month research study examining the effects on androgen treatment on sperm production in healthy men. There are three phase to the study, a 2-month screening phase, 4-month treatment and 3-month follow-up. In this study, the investigators aim to define a quantitative relationship between intra-testicular testosterone (IT-T) and spermatogenesis in man. Hormone levels will be measured in a small amount of testicular fluid at the beginning and end of treatment and sperm concentration will be measured.

Study Timeline

• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-28
• Study Start: 2019-06
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-18
• Primary Completion: 2021-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acyline; T Gel; placebo dutasteride, placebo ketoconazole	Testosterone 1% Gel	All men will receive Acyline 300 ug/kg subcutaneous (SQ) injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 1: placebo oral ketoconazole + placebo oral dutasteride for 4 months
Acyline; T gel; Ketoconazole; placebo	Testosterone 1% Gel	All men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 2: oral ketoconazole 400 mg + placebo oral dutasteride for 4 months
Acyline; T Gel; placebo dutasteride, placebo ketoconazole	placebo ketoconazole	All men will receive Acyline 300 ug/kg subcutaneous (SQ) injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 1: placebo oral ketoconazole + placebo oral dutasteride for 4 months
Acyline; Tgel; HCG	HCG	All men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 4: Human Chorionic gonadotropin (HCG) 60 IU injection every other day for 4 months.
Acyline; T Gel; placebo dutasteride, placebo ketoconazole	placebo dutasteride	All men will receive Acyline 300 ug/kg subcutaneous (SQ) injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 1: placebo oral ketoconazole + placebo oral dutasteride for 4 months
Acyline; Tgel; Ketoconazole; Dutasteride	Testosterone 1% Gel	All men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 3: Ketoconazole 400mg orally daily + Dutasteride 2.5 mg orally on day 1, followed by 0.5mg daily for 4 months
Acyline; T gel; Ketoconazole; placebo	placebo dutasteride	All men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 2: oral ketoconazole 400 mg + placebo oral dutasteride for 4 months
Acyline; Tgel; HCG	Testosterone 1% Gel	All men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 4: Human Chorionic gonadotropin (HCG) 60 IU injection every other day for 4 months.
Acyline; T gel; Ketoconazole; placebo	Ketoconazole	All men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 2: oral ketoconazole 400 mg + placebo oral dutasteride for 4 months
Acyline; Tgel; Ketoconazole; Dutasteride	Dutasteride	All men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 3: Ketoconazole 400mg orally daily + Dutasteride 2.5 mg orally on day 1, followed by 0.5mg daily for 4 months
Acyline; Tgel; Ketoconazole; Dutasteride	Ketoconazole	All men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 3: Ketoconazole 400mg orally daily + Dutasteride 2.5 mg orally on day 1, followed by 0.5mg daily for 4 months
Acyline; T Gel; placebo dutasteride, placebo ketoconazole	Acyline	All men will receive Acyline 300 ug/kg subcutaneous (SQ) injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 1: placebo oral ketoconazole + placebo oral dutasteride for 4 months
Acyline; T gel; Ketoconazole; placebo	Acyline	All men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 2: oral ketoconazole 400 mg + placebo oral dutasteride for 4 months
Acyline; Tgel; Ketoconazole; Dutasteride	Acyline	All men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 3: Ketoconazole 400mg orally daily + Dutasteride 2.5 mg orally on day 1, followed by 0.5mg daily for 4 months
Acyline; Tgel; HCG	Acyline	All men will receive Acyline 300 ug/kg SQ injections every 2-weeks + Testosterone 1% Gel 5g daily and then randomly assigned. Group 4: Human Chorionic gonadotropin (HCG) 60 IU injection every other day for 4 months.

Primary Outcome Measures

Name	Time	Method
Sperm concentration	16 weeks	Difference in sperm concentration at week 16 between 4 treatment groups

Secondary Outcome Measures

Name	Time	Method
IT steroid concentration	16 weeks	It steroid concentration at week 16 between the 4 treatment groups

Trial Locations

Locations (1)

University of Washington Medical Center (Health Sciences); 🇺🇸 Seattle, Washington, United States