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Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

HOP-3 Manipulation of the Intratesticular Hormonal Milieu With Exogenous Testosterone

Short name HOP-3

NCTNCT00839319 (opens ClinicalTrials.gov in a new tab)Other id27158-DOther idU54HD012629
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States

Start
Mar 2009
Primary completion
Sept 2010
Completion
Nov 2010
First posted
9 Feb 2009 (estimated)
Last update posted
11 Jan 2016 (estimated)
Conditions
Healthy Males

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011
  1. Ph 1/2

    HOP-3

    NCT00839319

    Mar 2009 to Nov 2010

Registry summary

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

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.

Interventions

  • AcylineDrug
  • placebo hCG (no active ingredient)Other
  • hCG (human chorionic gonadotropin)Drug
  • hCG (human chorionic gonadotropin)Drug
  • hCG (human chorionic gonadotropin)Drug
  • Testosterone gelDrug

Arms5

  • Experimental

    Acyline plus Placebo

    Acyline 300 ug/kg subcutaneous (SQ) injections on Day 1 plus subcutaneous placebo hCG injection (inj) every other day (5 doses) for 10 days

  • Experimental

    Acyline plus 15 IU hCG

    Acyline 300 ug/kg (SQ) inj(s) on Day 1 plus subcutaneous 15 IU hCG injection (inj) every other day (5 doses) for 10 days

  • Experimental

    Acyline plus 60 IU hCG

    Acyline 300 ug/kg subcutaneous (SQ) injections on Day 1 plus subcutaneous 60 IU hCG injection (inj) every other day (5 doses) for 10 days

  • Experimental

    Acyline plus 125 IU hCG

    Acyline 300 ug/kg subcutaneous (SQ) injections on Day 1 plus subcutaneous 125 IU hCG injection (inj) every other day (5 doses) for 10 days

  • Experimental

    Acyline plus Testosterone gel

    Acyline 300 ug/kg subcutaneous (SQ) injections on Day 1 plus Testosterone gel 75 mg/day daily for 10 days

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Serum Testosterone (T)

    Time frame · 10 days

  2. Serum Luteinizing Hormone (LH)

    Time frame · 10 days

  3. Serum Follicle Stimulating Hormone (FSH)

    Time frame · 10 days

  4. Intratesticular Testosterone (ITT-T)

    Time frame · 10 days

Posted results

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

Primary outcome results

Primary outcomeMedian· 10 days

Serum Testosterone (T)

GroupValue (nmol/liter)
Acyline Plus Placebo0.43
Acyline Plus 15 IU hCG1.5
Acyline Plus 60 IU hCG3.7
Acyline Plus 125 IU hCG8.4
Acyline Plus Testosterone Gel16
Primary outcomeMedian· 10 days

Serum Luteinizing Hormone (LH)

GroupValue (IU/L)
Acyline Plus Placebo0.13
Acyline Plus 15 IU hCG0.28
Acyline Plus 60 IU hCG0.49
Acyline Plus 125 IU hCG0.39
Acyline Plus Testosterone Gel0.14
Primary outcomeMedian· 10 days

Serum Follicle Stimulating Hormone (FSH)

GroupValue (IU/L)
Acyline Plus Placebo0.41
Acyline Plus 15 IU hCG0.41
Acyline Plus 60 IU hCG0.29
Acyline Plus 125 IU hCG0.28
Acyline Plus Testosterone Gel0.21
Primary outcomeMedian· 10 days

Intratesticular Testosterone (ITT-T)

GroupValue (IU/L)
Acyline Plus Placebo77
Acyline Plus 15 IU hCG136
Acyline Plus 60 IU hCG319
Acyline Plus 125 IU hCG987
Acyline Plus Testosterone Gel73

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Acyline Plus PlaceboAcyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days–0 / 61 / 6
Acyline Plus 15 IU hCGACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days–0 / 71 / 7
Acyline Plus 60 IU hCGACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days–0 / 53 / 5
Acyline Plus 125 IU hCGACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days–0 / 52 / 5
Acyline Plus Testosterone GelACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days–0 / 81 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

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

Studies3

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)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2013

Serum insulin-like factor 3 is highly correlated with intratesticular testosterone in normal men with acute, experimental gonadotropin deficiency stimulated with low-dose human chorionic gonadotropin: a randomized, controlled trial.

Roth et al. 2013Fertility and sterilitycited by 35

PMID 23040523PMC3534941DOI 10.1016/j.fertnstert.2012.09.009PUB-23040523

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 50 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Males age 18-50 * Normal serum testosterone, LH and FSH * PSA \< 4.0 * Agrees not to donate blood or participate in another research study during the study * Informed consent * In general good health based on normal screening evaluation (consisting of a medical history, physical exam, normal sperm count, normal serum chemistry and hematology) * Must be willing to use a reliable form of contraception during the study Exclusion Criteria: * Oligospermia (sperm count \< 15 million/mL after 48 hours of abstinence) and/or abnormal motility or morphology. * Participation in a long-term male contraceptive study within the past three months * History of testosterone or anabolic steroid abuse in the past * Poor general health with significantly abnormal blood results * History of or current testicular disease * History of a bleeding disorder or need for anticoagulation * History of sleep apnea and/or major psychiatric problems * BMI \> 32 * Subjects with a skin condition that might interfere or be exacerbated by testosterone gel use * Subject's with alcohol or drug use

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