NCT00399165

Brief Summary

The protocol was designed to address the hypothesis that oral testosterone enanthate plus dutasteride can suppress the secretion of LH and FSH after four weeks of administration. In addition, we will compare the gonadotropin suppression mediated by a dose of testosterone enanthate (400 mg twice daily) that would be expected to maintain the serum testosterone in the normal range throughout the day, with the same dose (800 mg once daily) administered once daily. This larger once-daily dose is expected to result in a higher peak and lower trough by the end of the dosing interval

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2006

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

November 1, 2006

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

September 22, 2008

Status Verified

September 1, 2008

Enrollment Period

6 months

First QC Date

November 9, 2006

Last Update Submit

September 18, 2008

Conditions

Contraception

Keywords

Oral Contraception for MenContraceptive agent

Outcome Measures

Primary Outcomes (1)

  • Dutasteride can suppress the secretion of LH and FSH after four weeks of administration.

    4 weeks

Secondary Outcomes (1)

  • The ability of oral testosterone enanthate plus dutasteride to maintain short-term androgen-medicated endpoints such as mood and sexual function over the 4-week treatment period

    4 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Oral Testosterone enanthate in sesame oil, 400 mg po (orally), BID (twice daily) + dutasteride 0.5 mg orally, qd (once daily) for 28 days + dutasteride load 24.5 mg po once

Drug: Testosterone EnanthateDrug: Dutasteride

2

ACTIVE COMPARATOR

Oral Testosterone sesame oil, 800 mg po (orally), qd (in am daily) + placebo sesame oil (in pm daily) + dutasteride 0.5 mg orally, qd (once daily) for 28 days + dutasteride load 24.5 mg po once

Drug: Testosterone EnanthateDrug: DutasterideOther: placebo sesame oil

Interventions

Testosterone EnanthateDRUG

Oral Testosterone 400 mg orally for 28 days

Also known as: Delatestryl
1
DutasterideDRUG

dutasteride 0.5 mg orally, once daily for 28 days

Also known as: Avodart
12
placebo sesame oilOTHER

placebo sesame oil

2

Eligibility Criteria

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

You may qualify if:

  • Males between 18 to 55 years of age
  • In good general health based on normal screening evaluation (consisting of a medical history, physical exam, normal serum chemistry, hematology, and baseline hormone levels)
  • Subject must agree not to participate in another research drug study for the duration of the study
  • Subject must agree to not donate blood during the study
  • Subject must be willing to comply with the study protocol and procedures

You may not qualify if:

  • Men in poor general health, with abnormal blood results (clinical laboratory tests or hormone values)
  • A known history of alcohol or drug abuse
  • A history of testicular disease or severe testicular trauma,
  • A history of bleeding disorders or current use of anti-coagulants
  • A history of sleep apnea and/or major psychiatric disorders
  • A body-mass index greater than 35,
  • A history of or current use of testosterone
  • Infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (9)

  • Martin CW, Anderson RA, Cheng L, Ho PC, van der Spuy Z, Smith KB, Glasier AF, Everington D, Baird DT. Potential impact of hormonal male contraception: cross-cultural implications for development of novel preparations. Hum Reprod. 2000 Mar;15(3):637-45. doi: 10.1093/humrep/15.3.637.

    PMID: 10686211BACKGROUND

  • Weston GC, Schlipalius ML, Bhuinneain MN, Vollenhoven BJ. Will Australian men use male hormonal contraception? A survey of a postpartum population. Med J Aust. 2002 Mar 4;176(5):208-10. doi: 10.5694/j.1326-5377.2002.tb04374.x.

    PMID: 11999235BACKGROUND

  • Heinemann K, Saad F, Wiesemes M, White S, Heinemann L. Attitudes toward male fertility control: results of a multinational survey on four continents. Hum Reprod. 2005 Feb;20(2):549-56. doi: 10.1093/humrep/deh574. Epub 2004 Dec 17.

    PMID: 15608042BACKGROUND

  • Amory JK, Bremner WJ. Oral testosterone in oil plus dutasteride in men: a pharmacokinetic study. J Clin Endocrinol Metab. 2005 May;90(5):2610-7. doi: 10.1210/jc.2004-1221. Epub 2005 Feb 15.

    PMID: 15713724BACKGROUND

  • Amory JK, Page ST, Bremner WJ. Oral testosterone in oil: pharmacokinetic effects of 5alpha reduction by finasteride or dutasteride and food intake in men. J Androl. 2006 Jan-Feb;27(1):72-8. doi: 10.2164/jandrol.05058.

    PMID: 16400081BACKGROUND

  • Bebb RA, Anawalt BD, Christensen RB, Paulsen CA, Bremner WJ, Matsumoto AM. Combined administration of levonorgestrel and testosterone induces more rapid and effective suppression of spermatogenesis than testosterone alone: a promising male contraceptive approach. J Clin Endocrinol Metab. 1996 Feb;81(2):757-62. doi: 10.1210/jcem.81.2.8636300.

    PMID: 8636300BACKGROUND

  • Anawalt BD, Bebb RA, Bremner WJ, Matsumoto AM. A lower dosage levonorgestrel and testosterone combination effectively suppresses spermatogenesis and circulating gonadotropin levels with fewer metabolic effects than higher dosage combinations. J Androl. 1999 May-Jun;20(3):407-14.

    PMID: 10386821BACKGROUND

  • Anawalt BD, Amory JK, Herbst KL, Coviello AD, Page ST, Bremner WJ, Matsumoto AM. Intramuscular testosterone enanthate plus very low dosage oral levonorgestrel suppresses spermatogenesis without causing weight gain in normal young men: a randomized clinical trial. J Androl. 2005 May-Jun;26(3):405-13. doi: 10.2164/jandrol.04135.

    PMID: 15867009BACKGROUND

  • Amory JK, Kalhorn TF, Page ST. Pharmacokinetics and pharmacodynamics of oral testosterone enanthate plus dutasteride for 4 weeks in normal men: implications for male hormonal contraception. J Androl. 2008 May-Jun;29(3):260-71. doi: 10.2164/jandrol.107.004226. Epub 2007 Nov 28.

    PMID: 18046048RESULT

MeSH Terms

Interventions

testosterone enanthateDutasteride

Intervention Hierarchy (Ancestors)

AzasteroidsSteroids, HeterocyclicSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • John K Amory, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2006

First Posted

November 14, 2006

Study Start

November 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

September 22, 2008

Record last verified: 2008-09

Locations

US(1)