CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
Acyline +5 moredrug
Likely dose
hCG (human chorionic gonadotropin) 15 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00839319
NCT00839319Phase 2Completed
CompareCT.gov

Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone (Short Title (HOP-3)

University of Washington·interventional·Posted Feb 9, 2009·Updated Jan 11, 2016

In Brief

A Phase 2 clinical trial evaluating Acyline, placebo hCG (no active ingredient), and 2 other interventions for Healthy Males. Completed, enrolled 59 participants across 1 site.

Detailed Summary

The purpose of this investigational 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Males
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 9, 2009
Enrollment StartMar 1, 2009
Primary CompletionSep 1, 2010
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.4 years ago

Interventions

Acylinedrug

300 ug/kg subcutaneous injections on Day 1.

placebo hCG (no active ingredient)other

placebo hCG

hCG (human chorionic gonadotropin)drug

15 IU subcutaneous injection every other day for 10 days (5 doses)

hCG (human chorionic gonadotropin)drug

60 IU subcutaneous injection

hCG (human chorionic gonadotropin)drug

125 IU subcutaneous injection

Testosterone geldrug

75 mg testosterone gel applied transdermally for 10 days