NCT01167829

Brief Summary

The purpose of this study is to test how the body absorbs a new form of oral testosterone (T). On Day 1 and Day 9 there are overnight stays in the General Clinical Research Center at the University of Washington to monitor blood testosterone levels over a 24-hour period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_1 healthy

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

July 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 23, 2013

Completed
Last Updated

September 6, 2013

Status Verified

August 1, 2013

Enrollment Period

3 months

First QC Date

July 20, 2010

Results QC Date

September 25, 2012

Last Update Submit

August 23, 2013

Conditions

Healthy

Keywords

ExperimentalAcyline plus 27 oral testosterone pillstaken 3x/day

Outcome Measures

Primary Outcomes (2)

  • Maximum Testosterone Concentration

    initial pharmacokinetics \[PK\] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment

    baseline & day 9

  • Mean Testosterone Concentration

    initial 24-hour pharmacokinetics (PK) of oral testosterone dosed 3 times daily and post 24-hour PK after 9 days of treatment

    baseline & day 9

Secondary Outcomes (8)

  • Maximum Dihydrotestosterone (DHT) Concentration

    baseline & day 9

  • Mean Dihydrotestosterone (DHT) Concentration

    baseline & day 9

  • Maximum Sex Hormone-Binding Globulin (SHGB)Concentration

    baseline & day 9

  • Mean SHGB Concentration

    baseline & day 9

  • Maximum Estradiol Concentration

    baseline & day 9

  • +3 more secondary outcomes

Study Arms (1)

Acyline and oral testosterone

EXPERIMENTAL
Drug: Oral TestosteroneDrug: Acyline

Interventions

Oral TestosteroneDRUG

Oral Testosterone: 300 mg, pills, three times daily Day 1 - 10 (total of 27 pills)

Acyline and oral testosterone
AcylineDRUG

300 ug/kg injection on Day 0

Acyline and oral testosterone

Eligibility Criteria

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

You may qualify if:

  • able and willing to
  • not participate in another drug study or donate blood, not take medications
  • use contraception, comply with the protocol

You may not qualify if:

  • abnormal evaluation, based on physical exam, medical history, blood tests (including serum chemistry, hematology, HIV, HCV, hormone levels)
  • history or current use of alcohol, drug, steroid abuse, \>3 alcohol drinks/day
  • history of testicular disease, severe testicular trauma, major psychiatric disorder, bleeding disorders, current use of anti-coagulants or testosterone
  • participation in hormonal drug study within past month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (17)

  • Katznelson L, Finkelstein JS, Schoenfeld DA, Rosenthal DI, Anderson EJ, Klibanski A. Increase in bone density and lean body mass during testosterone administration in men with acquired hypogonadism. J Clin Endocrinol Metab. 1996 Dec;81(12):4358-65. doi: 10.1210/jcem.81.12.8954042.

    PMID: 8954042BACKGROUND

  • Behre HM, Kliesch S, Leifke E, Link TM, Nieschlag E. Long-term effect of testosterone therapy on bone mineral density in hypogonadal men. J Clin Endocrinol Metab. 1997 Aug;82(8):2386-90. doi: 10.1210/jcem.82.8.4163.

    PMID: 9253305BACKGROUND

  • Bhasin S, Bremner WJ. Clinical review 85: Emerging issues in androgen replacement therapy. J Clin Endocrinol Metab. 1997 Jan;82(1):3-8. doi: 10.1210/jcem.82.1.3640. No abstract available.

    PMID: 8989221BACKGROUND

  • Wang C, Alexander G, Berman N, Salehian B, Davidson T, McDonald V, Steiner B, Hull L, Callegari C, Swerdloff RS. Testosterone replacement therapy improves mood in hypogonadal men--a clinical research center study. J Clin Endocrinol Metab. 1996 Oct;81(10):3578-83. doi: 10.1210/jcem.81.10.8855804.

    PMID: 8855804BACKGROUND

  • Snyder PJ, Peachey H, Berlin JA, Hannoush P, Haddad G, Dlewati A, Santanna J, Loh L, Lenrow DA, Holmes JH, Kapoor SC, Atkinson LE, Strom BL. Effects of testosterone replacement in hypogonadal men. J Clin Endocrinol Metab. 2000 Aug;85(8):2670-7. doi: 10.1210/jcem.85.8.6731.

    PMID: 10946864BACKGROUND

  • Kelch RP, Jenner MR, Weinstein R, Kaplan SL, Grumbach MM. Estradiol and testosterone secretion by human, simian, and canine testes, in males with hypogonadism and in male pseudohermaphrodites with the feminizing testes syndrome. J Clin Invest. 1972 Apr;51(4):824-30. doi: 10.1172/JCI106877.

    PMID: 4259253BACKGROUND

  • Weinstein RL, Kelch RP, Jenner MR, Kaplan SL, Grumbach MM. Secretion of unconjugated androgens and estrogens by the normal and abnormal human testis before and after human chorionic gonadotropin. J Clin Invest. 1974 Jan;53(1):1-6. doi: 10.1172/JCI107526.

    PMID: 4271572BACKGROUND

  • Herbst KL, Anawalt BD, Amory JK, Bremner WJ. Acyline: the first study in humans of a potent, new gonadotropin-releasing hormone antagonist. J Clin Endocrinol Metab. 2002 Jul;87(7):3215-20. doi: 10.1210/jcem.87.7.8675.

    PMID: 12107227BACKGROUND

  • Herbst KL, Coviello AD, Page S, Amory JK, Anawalt BD, Bremner WJ. A single dose of the potent gonadotropin-releasing hormone antagonist acyline suppresses gonadotropins and testosterone for 2 weeks in healthy young men. J Clin Endocrinol Metab. 2004 Dec;89(12):5959-65. doi: 10.1210/jc.2003-032123.

    PMID: 15579744BACKGROUND

  • Bagatell CJ, Bremner WJ. Androgens in men--uses and abuses. N Engl J Med. 1996 Mar 14;334(11):707-14. doi: 10.1056/NEJM199603143341107. No abstract available.

    PMID: 8594431BACKGROUND

  • Fossa SD, Opjordsmoen S, Haug E. Androgen replacement and quality of life in patients treated for bilateral testicular cancer. Eur J Cancer. 1999 Aug;35(8):1220-5. doi: 10.1016/s0959-8049(99)00123-9.

    PMID: 10615233BACKGROUND

  • Swerdloff RS, Wang C, Cunningham G, Dobs A, Iranmanesh A, Matsumoto AM, Snyder PJ, Weber T, Longstreth J, Berman N. Long-term pharmacokinetics of transdermal testosterone gel in hypogonadal men. J Clin Endocrinol Metab. 2000 Dec;85(12):4500-10. doi: 10.1210/jcem.85.12.7045.

    PMID: 11134099BACKGROUND

  • Snyder CN, Clark RV, Caricofe RB, Bush MA, Roth MY, Page ST, Bremner WJ, Amory JK. Pharmacokinetics of 2 novel formulations of modified-release oral testosterone alone and with finasteride in normal men with experimental hypogonadism. J Androl. 2010 Nov-Dec;31(6):527-35. doi: 10.2164/jandrol.109.009746. Epub 2010 Apr 8.

    PMID: 20378927BACKGROUND

  • de Ronde W. Hyperandrogenism after transfer of topical testosterone gel: case report and review of published and unpublished studies. Hum Reprod. 2009 Feb;24(2):425-8. doi: 10.1093/humrep/den372. Epub 2008 Oct 23.

    PMID: 18948313BACKGROUND

  • Brachet C, Vermeulen J, Heinrichs C. Children's virilization and the use of a testosterone gel by their fathers. Eur J Pediatr. 2005 Oct;164(10):646-7. doi: 10.1007/s00431-005-1714-z. Epub 2005 Jul 16.

    PMID: 16025298BACKGROUND

  • Amory JK, Matsumoto AM. The therapeutic potential of testosterone patches. Expert Opin Investig Drugs. 1998 Dec;7(12):1977-85. doi: 10.1517/13543784.7.12.1977.

    PMID: 15991940BACKGROUND

  • 1. Plymate SR "Male Hypogonadism" in Principles and Practice of Endocrinology and Metabolism (3rd. Ed). Ed. Kenneth Becker, pp:1125-1150

    BACKGROUND

MeSH Terms

Interventions

Testosteroneacyline

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
John Amory, MD
Organization
University of Washington, Dept. of Medicine
jamory@u.washington.edu
(206) 616-1727

Study Officials

  • John K Amory, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 20, 2010

First Posted

July 22, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2010

Study Completion

June 1, 2012

Last Updated

September 6, 2013

Results First Posted

August 23, 2013

Record last verified: 2013-08

Locations

US(1)