MedDataX Logo

Oral Androgens in Man-4: (Short Title: Oral T-4)

NCT ID: NCT00399165

Last Updated: 2008-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will be carried out in a double-blinded fashion, so neither the subject nor the investigator will be aware of treatment assignment during the study. This protocol is 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. Secondary endpoints in this study include the ability of oral testosterone enanthate plus dutasteride to maintain short-term androgen-mediated endpoints such as mood and sexual function over the 4-week treatment period as well as weekly measures of safety, including blood counts, PSA and liver and kidney function.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraception

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Oral Contraception for Men Contraceptive agent

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type ACTIVE_COMPARATOR

Testosterone Enanthate

Intervention Type DRUG

Oral Testosterone 400 mg orally for 28 days

Dutasteride

Intervention Type DRUG

dutasteride 0.5 mg orally, once daily for 28 days

Dutasteride

Intervention Type DRUG

24.5 mg po once (Day 0)

2

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

Group Type ACTIVE_COMPARATOR

Testosterone Enanthate

Intervention Type DRUG

Oral Testosterone 800 mg orally for 28 days

Dutasteride

Intervention Type DRUG

dutasteride 0.5 mg orally, once daily for 28 days

placebo sesame oil

Intervention Type OTHER

placebo sesame oil

Dutasteride

Intervention Type DRUG

24.5 mg po once (Day 0)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Testosterone Enanthate

Oral Testosterone 400 mg orally for 28 days

Intervention Type DRUG

Testosterone Enanthate

Oral Testosterone 800 mg orally for 28 days

Intervention Type DRUG

Dutasteride

dutasteride 0.5 mg orally, once daily for 28 days

Intervention Type DRUG

placebo sesame oil

placebo sesame oil

Intervention Type OTHER

Dutasteride

24.5 mg po once (Day 0)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Delatestryl Delatestryl Avodart Avodart

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Washington

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John K Amory, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Washington

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 10686211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11999235 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15608042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15713724 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16400081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8636300 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10386821 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15867009 (View on PubMed)

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.

Reference Type RESULT
PMID: 18046048 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U54HD042454

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23HD045386

Identifier Type: NIH

Identifier Source: secondary_id

View Link

06-2962-A

Identifier Type: -

Identifier Source: org_study_id