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Trial · Interventional

WithdrawnPhase 2Registry data

ITT-5 Mechanisms of Spermatogenesis in Man

Short name ITT-5

NCTNCT02147964 (opens ClinicalTrials.gov in a new tab)Other idSTUDY00001449
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 2
Enrollment
0 participants (actual)
Sponsor
University of Washington · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jun 2019 (estimated)
Primary completion
Dec 2021 (estimated)
Completion
Dec 2026 (estimated)
First posted
28 May 2014 (estimated)
Last update posted
18 Dec 2019
Conditions
Gonadotropin Deficiency

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202220242026
  1. Ph 2

    ITT-5

    NCT02147964

    est. Jun 2019 to est. Dec 2026

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Testosterone 1% GelDrug
  • AcylineDrug
  • DutasterideDrug
  • KetoconazoleDrug
  • HCGDrug
  • placebo dutasterideDrug
  • placebo ketoconazoleDrug

Arms4

  • 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

  • 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

  • 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

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Sperm concentration

    Time frame · 16 weeks

    Registry description

    Difference in sperm concentration at week 16 between 4 treatment groups

Secondary outcomes(1)

  1. IT steroid concentration

    Time frame · 16 weeks

    Registry description

    It steroid concentration at week 16 between the 4 treatment groups

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2010

3 results

Dose-dependent increase in intratesticular testosterone by very low-dose human chorionic gonadotropin in normal men with experimental gonadotropin deficiency.

Roth et al. 2010The Journal of clinical endocrinology and metabolismcited by 49

PMID 20484472PMC2913032DOI 10.1210/jc.2010-0360PUB-20484472

Rights unknown3 results
Source linkSee results (3)

Indexing hint: Randomized controlled trial · 2005

4 results

Low-dose human chorionic gonadotropin maintains intratesticular testosterone in normal men with testosterone-induced gonadotropin suppression.

Coviello et al. 2005The Journal of clinical endocrinology and metabolismcited by 96

PMID 15713727DOI 10.1210/jc.2004-0802PUB-15713727

Rights unknown4 results
Source linkSee results (4)

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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