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ITT-5 Mechanisms of Spermatogenesis in Man

NCT02147964 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-12-18

No results posted yet for this study

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.

Conditions

  • Gonadotropin Deficiency

Interventions

DRUG

Testosterone 1% Gel

Testosterone 1% gel 5g daily for 4 months \[all subjects\]

DRUG

Acyline

Acyline 300 ug/kg SQ injections every 2-weeks for 4 months \[all subjects\]

DRUG

Dutasteride

Dutasteride 2.5 mg (day 1) followed by 0.5 mg daily for 4 months

DRUG

Ketoconazole

ketoconazole 400 mg PO daily for 4 months

DRUG

HCG

HCG 60 IU injection Subcutaneously, every other day for 4 months

DRUG

placebo dutasteride

placebo oral dutasteride PO daily for 4 months

DRUG

placebo ketoconazole

placebo ketoconazole daily for 4 months

Sponsors & Collaborators

Principal Investigators

  • Mara Roth, MD · University of Washington

  • William J Bremner, MD, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2021-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02147964 on ClinicalTrials.gov