HealthyPhase 1Oral T8NCT01167829

ORAL T-8 Oral Testosterone for Male Hormonal Contraception

A Phase 1 study testing Oral Testosterone and Acyline in people with Healthy, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Oral Testosterone and Acyline
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Jul 2010to Jun 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington
Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Pharmacokinetics of Modified Slow-Release Oral Testosterone Over 10 Days in Normal Men With Experimental Hypogonadism

Read the detailed description

We will administer two experimental drugs, acyline and oral testosterone. Acyline shots will be given on Day 0 to turn off the body's testosterone production for about 10-14 days.

The next day, Day 1, subjects begin taking 300 mg modified slow-release testosterone pill by mouth, three times a day, around 9 AM, 1 PM, and 7 PM for a total of 27 pills.

There are overnight stays on Day 1 and Day 9 to allow monitoring of blood testosterone levels over a 24 hour period, from @9 AM to 9 AM the next morning. At those visits, blood is drawn at baseline (before taking the pill) and at 1, 2, 4, 5, 6, 8, 10, 11, 12, 14, 16, and 24 hours after the morning dose.

Acyline is an experimental drug. The FDA allows its use only in research with a small number of volunteers. We have used acyline in over 125 men without serious side effects. The use of testosterone in this study is experimental and there may be unknown or unanticipated risks.

Conditions: Healthy
Being tested: Oral Testosterone, Acyline
Keywords: Experimental, Acyline plus 27 oral testosterone pills, taken 3x/day

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral TestosteroneDrug
Oral Testosterone: 300 mg, pills, three times daily Day 1 - 10 (total of 27 pills)
AcylineDrug
300 ug/kg injection on Day 0

Study groups in NCT01167829
Study group	Role	What they receive
Acyline and oral testosterone	Experimental	Not described Receives: Drug: Oral Testosterone; Drug: Acyline

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Testosterone Concentration
initial pharmacokinetics [PK] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment
Measured: 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
Measured: baseline & day 9

Secondary outcomes (8)

Maximum Dihydrotestosterone (DHT) Concentration
Measured: baseline & day 9
Mean Dihydrotestosterone (DHT) Concentration
Measured: baseline & day 9
Maximum Sex Hormone-Binding Globulin (SHGB)Concentration
Measured: baseline & day 9
Mean SHGB Concentration
Measured: baseline & day 9
Maximum Estradiol Concentration
Measured: baseline & day 9
Mean Estradiol Concentration
Measured: baseline & day 9
Free T Maximum Concentration
Free T normal range 4.7-18 ng/dL
Measured: baseline & day 9
Free Testosterone Mean Concentration
Free T normal range 4.7-18 ng/dL
Measured: baseline & day 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Jun 2012

First posted22 Jul 2010 (estimated)
Study startJul 2010
Primary completionOct 2010
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01167829
Sponsor's protocol ID: 38636-D
Acronym: Oral T8
Status last verified: Aug 2013
First submitted: 20 Jul 2010
Last updated: 6 Sep 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 8954042
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.
PubMed 9253305
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.
PubMed 8989221
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.
PubMed 8855804
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.
PubMed 10946864
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.
PubMed 4259253
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.
PubMed 4271572
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.
PubMed 12107227
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.
PubMed 15579744
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.
PubMed 8594431
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.
PubMed 10615233
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.
PubMed 11134099
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.
PubMed 20378927
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.
PubMed 18948313
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.
PubMed 16025298

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of Modified Slow-Release Oral Testosterone Over 10 Days in Normal Men With Experimental Hypogonadism
ClinicalTrials.gov ID: NCT01167829
Acronym / sponsor ID: Oral T8 / 38636-D
Conditions: Healthy
Keywords: Experimental, Acyline plus 27 oral testosterone pills, taken 3x/day
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: Jul 2010
Primary completion: Oct 2010 (actual)
Study completion: Jun 2012 (actual)
First posted: 22 Jul 2010 (estimated)
Results: Posted 23 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

We will administer two experimental drugs, acyline and oral testosterone. Acyline shots will be given on Day 0 to turn off the body's testosterone production for about 10-14 days.

The next day, Day 1, subjects begin taking 300 mg modified slow-release testosterone pill by mouth, three times a day, around 9 AM, 1 PM, and 7 PM for a total of 27 pills.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Acyline and oral testosterone	Experimental	Drug: Oral Testosterone, Drug: Acyline

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral TestosteroneOral Testosterone: 300 mg, pills, three times daily Day 1 - 10 (total of 27 pills)	Drug	Acyline and oral testosterone
Acyline300 ug/kg injection on Day 0	Drug	Acyline and oral testosterone

Primary outcome

Maximum Testosterone Concentration
Time frame: baseline & day 9
initial pharmacokinetics [PK] (day 1) of oral testosterone dosed 3 times daily and the PK after 9 days of treatment
Mean Testosterone Concentration
Time frame: baseline & day 9
initial 24-hour pharmacokinetics (PK) of oral testosterone dosed 3 times daily and post 24-hour PK after 9 days of treatment

8 secondary outcomes

Maximum Dihydrotestosterone (DHT) Concentration
Time frame: baseline & day 9
Mean Dihydrotestosterone (DHT) Concentration
Time frame: baseline & day 9
Maximum Sex Hormone-Binding Globulin (SHGB)Concentration
Time frame: baseline & day 9
Mean SHGB Concentration
Time frame: baseline & day 9
Maximum Estradiol Concentration
Time frame: baseline & day 9
Mean Estradiol Concentration
Time frame: baseline & day 9
Free T Maximum Concentration
Time frame: baseline & day 9
Free Testosterone Mean Concentration
Time frame: baseline & day 9

Results and safety

Results posted to the registry on 23 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acyline and 0ral Testosterone	12	12

Primary outcome: Maximum Testosterone Concentration

Time frame: baseline & day 9. Geometric mean (Geometric Coefficient of Variation). Unit: ng/dL

Measure	Acyline and 300 mg Oral Testosterone n = 12
Day 1	924 (44)
Day 9	741 (71)

Acyline and 300 mg Oral Testosterone: Mean Difference (Net): 183, p = 0.05, t-test, 2 sided

Population analysed: per protocol

Primary outcome: Mean Testosterone Concentration

Time frame: baseline & day 9. Geometric mean (Geometric Coefficient of Variation). Unit: ng/dL

Measure	Acyine and 300 mg Oral Testosterone n = 12
Day 1	378 (45)
Day 9	315 (41)

Population analysed: per protocol

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 months, July - October 2010. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acyline and Oral Testosterone	0 of 12 (0%)	8 of 12 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8954042Katznelson 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.
Background: PubMed 9253305Behre 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.
Background: PubMed 8989221Bhasin 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.
Background: PubMed 8855804Wang 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.
Background: PubMed 10946864Snyder 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.
Background: PubMed 4259253Kelch 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.
Background: PubMed 4271572Weinstein 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.
Background: PubMed 12107227Herbst 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.
Background: PubMed 15579744Herbst 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.
Background: PubMed 8594431Bagatell 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.
Background: PubMed 10615233Fossa 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.
Background: PubMed 11134099Swerdloff 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John K Amory, MD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oral Testosterone and Acyline in people with Healthy, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Testosterone Concentration (time frame: baseline & day 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01167829, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2013.