NCT00156650

Brief Summary

This study is being offered to all participants of the ACY-5 study as an optional addition to the male contraceptive study in which they participated. Participation is voluntary. The purpose of this added procedure (Testicular Aspiration-HOP 3) is to determine the amount of testosterone (male hormone) in the testes of men who are on a male contraceptive regimen.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

September 19, 2008

Status Verified

September 1, 2008

Enrollment Period

7 months

First QC Date

September 8, 2005

Last Update Submit

September 18, 2008

Conditions

Contraception

Keywords

Male contraceptionTestosterone

Outcome Measures

Primary Outcomes (1)

  • Intratesticular hormone levels

    One year

Secondary Outcomes (1)

  • sperm count levels

    One year

Study Arms (2)

1

ACTIVE COMPARATOR

Testosterone (T) gel for 6 months + DMPA (Depo-Medroxyprogesterone) (injected into muscle Day 0 \& at Month 3)

Drug: Testosterone GelDrug: Depo-Medroxyprogesterone

2

ACTIVE COMPARATOR

T gel for 6 months + DMPA (Day 0 \& Month 3) + Acyline 300 mcg/kg twice monthly for 12 weeks

Drug: AcylineDrug: Testosterone GelDrug: Depo-Medroxyprogesterone

Interventions

AcylineDRUG

Acyline 300 mcg/kg SQ(Subcutaneously)twice monthly for 12 weeks

2
Testosterone GelDRUG

Testosterone (T) gel 10 g daily for 6 months

Also known as: Testim
12
Depo-MedroxyprogesteroneDRUG

300 mg IM every 3 months

Also known as: DMPA
12

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male between 18-55
  • In good health
  • With normal sperm counts and willing to use an acceptable form of contraception during the study

You may not qualify if:

  • Male in poor health
  • Significant chronic or acute medical illness
  • Skin conditions that might interfere with or be exacerbated by testosterone gel
  • No history of alcohol, illicit drug or anabolic steroid abuse
  • Abnormal reproductive function
  • Participation in a long-term male contraceptive study within three months of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

  • Coviello AD, Bremner WJ, Matsumoto AM, Herbst KL, Amory JK, Anawalt BD, Yan X, Brown TR, Wright WW, Zirkin BR, Jarow JP. Intratesticular testosterone concentrations comparable with serum levels are not sufficient to maintain normal sperm production in men receiving a hormonal contraceptive regimen. J Androl. 2004 Nov-Dec;25(6):931-8. doi: 10.1002/j.1939-4640.2004.tb03164.x.

    PMID: 15477366BACKGROUND

  • Coviello AD, Matsumoto AM, Bremner WJ, Herbst KL, Amory JK, Anawalt BD, Sutton PR, Wright WW, Brown TR, Yan X, Zirkin BR, Jarow JP. Low-dose human chorionic gonadotropin maintains intratesticular testosterone in normal men with testosterone-induced gonadotropin suppression. J Clin Endocrinol Metab. 2005 May;90(5):2595-602. doi: 10.1210/jc.2004-0802. Epub 2005 Feb 15.

    PMID: 15713727BACKGROUND

  • Page ST, Kalhorn TF, Bremner WJ, Anawalt BD, Matsumoto AM, Amory JK. Intratesticular androgens and spermatogenesis during severe gonadotropin suppression induced by male hormonal contraceptive treatment. J Androl. 2007 Sep-Oct;28(5):734-41. doi: 10.2164/jandrol.107.002790. Epub 2007 May 9.

    PMID: 17494097RESULT

MeSH Terms

Interventions

acylineTestosteroneMedroxyprogesterone AcetateN,N-dimethyl-4-anisidine

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsMedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanes

Study Officials

  • William Bremner, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

December 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

September 19, 2008

Record last verified: 2008-09

Locations

US(1)