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NCT01215292 · ClinicalTrials.gov registry record · Phase 1

ITT4 Intratesticular Hormonal Milieu in Man (ITT4)

A Phase 1 study, sponsored by University of Washington.

Completed
Registry status
Phase 1
Development phase
46
Enrollment target

NCT01215292 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 46 participants.

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The verdict

NCT01215292, a Phase 1 study, has completed, sponsored by University of Washington.

COMPLETED
Registry status
Phase 1
Development phase
46 participants
Enrollment target

Study Summary

The purpose of this research study is to determine how much male hormone, testosterone, is necessary to maintain sperm production in the testis. This knowledge will be used to help in the development of a safe male hormonal contraception. Specific Aims: 1. to determine if ketoconazole plus acyline will suppress intratesticular testosterone(ITT) to a greater degree than acyline alone. 2. to determine if dutasteride plus acyline will suppress intratesticular dihydrotestosterone (IT-DHT) to a greater degree than acyline alone. 3. to determine if anastrazole plus acyline will suppress intratesticular estradiol(IT-E2) to a greater degree than acyline alone.

Interventions

  • DRUG Dutasteride
  • DRUG Acyline
  • DRUG Testosterone gel
  • DRUG ketoconazole 400
  • DRUG Ketoconazole 800

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2011-01
Est. Completion 2012-03
Phase Phase 1

Sponsor

University of Washington

1,048 total trials

What the Registry Record Tells You About NCT01215292

The ClinicalTrials.gov registry entry for NCT01215292 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Dutasteride is the first listed.

NCT01215292 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01215292 about?

NCT01215292 is a clinical study titled "ITT4 Intratesticular Hormonal Milieu in Man (ITT4)". The purpose of this research study is to determine how much male hormone, testosterone, is necessary to maintain sperm production in the testis. This knowledge will be used to help in the development of a safe male hormonal contraception. Specific Aims: 1. to determine if ketoconazole plus acyline...

What is the current status of trial NCT01215292?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2011-01. Estimated completion is 2012-03.

What interventions are being tested in trial NCT01215292?

The interventions under investigation include: Dutasteride (DRUG), Acyline (DRUG), Testosterone gel (DRUG), ketoconazole 400 (DRUG), Ketoconazole 800 (DRUG).

Who is sponsoring clinical trial NCT01215292?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.