ITT-5 Mechanisms of Spermatogenesis in Man (ITT-5)

December 16, 2019 updated by: William Bremner, University of Washington

Mechanisms of Hormonal Control of Spermatogenesis in Man

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center (Health Sciences)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acyline; T Gel; placebo dutasteride, 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
Drug: Testosterone 1% Gel
Testosterone 1% gel 5g daily for 4 months [all subjects]
Other Names:
  • Testosterone gel
  • AndroGel
  • T gel
Drug: Acyline
Acyline 300 ug/kg SQ injections every 2-weeks for 4 months [all subjects]
Drug: placebo dutasteride
placebo oral dutasteride PO daily for 4 months
Drug: placebo ketoconazole
placebo ketoconazole daily for 4 months
Experimental: Acyline; T gel; Ketoconazole; placebo

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
Drug: Testosterone 1% Gel
Testosterone 1% gel 5g daily for 4 months [all subjects]
Other Names:
  • Testosterone gel
  • AndroGel
  • T gel
Drug: Acyline
Acyline 300 ug/kg SQ injections every 2-weeks for 4 months [all subjects]
Drug: placebo dutasteride
placebo oral dutasteride PO daily for 4 months
Drug: Ketoconazole
ketoconazole 400 mg PO daily for 4 months
Experimental: Acyline; Tgel; Ketoconazole; 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
Drug: Testosterone 1% Gel
Testosterone 1% gel 5g daily for 4 months [all subjects]
Other Names:
  • Testosterone gel
  • AndroGel
  • T gel
Drug: Acyline
Acyline 300 ug/kg SQ injections every 2-weeks for 4 months [all subjects]
Drug: Ketoconazole
ketoconazole 400 mg PO daily for 4 months
Drug: Dutasteride
Dutasteride 2.5 mg (day 1) followed by 0.5 mg daily for 4 months
Other Names:
  • Avodart
Experimental: Acyline; Tgel; 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.
Drug: Testosterone 1% Gel
Testosterone 1% gel 5g daily for 4 months [all subjects]
Other Names:
  • Testosterone gel
  • AndroGel
  • T gel
Drug: Acyline
Acyline 300 ug/kg SQ injections every 2-weeks for 4 months [all subjects]
Drug: HCG
HCG 60 IU injection Subcutaneously, every other day for 4 months
Other Names:
  • Human chorionic gonadotropin (HCG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sperm concentration
Time Frame: 16 weeks
Difference in sperm concentration at week 16 between 4 treatment groups
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IT steroid concentration
Time Frame: 16 weeks
It steroid concentration at week 16 between the 4 treatment groups
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Mara Roth, MD, University of Washington
  • Study Director: William J Bremner, MD, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimate)

May 28, 2014

Study Record Updates

Last Update Posted (Actual)

December 18, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001449

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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