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ORAL T-6: Oral Androgens in Man-6

Oral Androgens in Man-6: Pharmacokinetics of Slow and Fast Release, External Matrix Oral Testosterone Formulations in Normal Men With Experimental Hypogonadism

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00663793
Acronym
ORAL-T-6
Enrollment
16
Registered
2008-04-22
Start date
2008-10-31
Completion date
2009-06-30
Last updated
2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, Hypogonadism

Keywords

Male Contraception, Hypogonadism, Testosterone

Brief summary

We propose a study to determine the single-dose pharmacokinetics of these two novel formulations of testosterone in normal men with experimentally induced hypogonadism.

Detailed description

This is an 2-3 month open-label, two week pharmacokinetic study of two novel formulations of oral testosterone (T), in normal men whose endogenous T production has been temporarily suppressed by the administration of the potent GnRH antagonist Acyline. We will be determining the relative pharmacokinetics of six different oral formulations of T in both rapid and slow release compared to the immediate release preparation studied previously by our group.

Interventions

DRUGAcyline

300 mcg/kg

DRUGTestosterone

24 hours after acyline administration on Day 2 immediate release Testosterone (T) 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once.

DRUGFinasteride

1 mg PO once daily \[day -2 to day 12) 14 days total

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Washington
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* males between 18 to 50 years of age in good general health based on normal screening evaluation * must agree not to participate in another research drug study during participation * must agree to not donate blood during the study * must be willing to comply with the study protocol and procedures * must agree to use an acceptable form of contraception * agrees to not take medications other than the study drugs for the duration of the study

Exclusion criteria

* Subject in poor health, determined by medical history physical and lab results * a known history or current use of alcohol, drug or steroid abuse and/or use of more than 3 alcohol beverages per day * Participation in a long-term contraceptive study within the past two months * History of bleeding disorders or current use of anti-coagulants * History of sleep apnea and/or major psychiatric disorders

Design outcomes

Primary

MeasureTime frame
Area Under the Curve-Serum T14 days

Secondary

MeasureTime frame
Area Under the Curve-serum DHT14-days
Area Under the Curve-E214 Days

Countries

United States

Participant flow

Recruitment details

Subjects were recruited through news media (newspaper, website) and college campus bulletin boards in Seattle WA, between April 2008-March 2009.

Pre-assignment details

19 participants recruited; 19 screened, 2 excluded.

Participants by arm

ArmCount
Testosterone Only
(Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once.
8
Testosterone Plus Finasteride
(Day -2 to Day 12) 1 mg Finasteride PO once daily for 14 days total. (Day 1) Acyline 300 mcg/kg once, followed 24 hours later (Day 2) by immediate release T 300 mg po once (as a control), followed 24 hours later (Day 3) by external matrix fast release T 300 mg once, followed 24 hours later (Day 4) by external matrix slow release T 300 mg once, followed 96 hours later (Day 8) by immediate release T 600 mg, followed 24 hours later (Day 9) by external matrix fast release T 600 mg po once, followed 48 hours later (Day 11) by external matrix slow release T 600 mg once.
8
Total16

Baseline characteristics

CharacteristicTestosterone OnlyTestosterone Plus FinasterideTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
8 Participants8 Participants16 Participants
Body Mass Index (BMI)26 kg/m^2
STANDARD_DEVIATION 4
28 kg/m^2
STANDARD_DEVIATION 8
27 kg/m^2
STANDARD_DEVIATION 4
Estradiol70.1 pmol/L
STANDARD_DEVIATION 16.1
114 pmol/L
STANDARD_DEVIATION 54
92.0 pmol/L
STANDARD_DEVIATION 35
Height178 centimeters
STANDARD_DEVIATION 5
179 centimeters
STANDARD_DEVIATION 7
178.5 centimeters
STANDARD_DEVIATION 6
Region of Enrollment
United States
8 participants8 participants16 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
8 Participants8 Participants16 Participants
Sex Hormone Binding Globulin (SHBG)35.5 nmol/L
STANDARD_DEVIATION 12.8
32.5 nmol/L
STANDARD_DEVIATION 19.6
34 nmol/L
STANDARD_DEVIATION 16.2
Testosterone (T)14.5 nmol/L
STANDARD_DEVIATION 2.5
16.8 nmol/L
STANDARD_DEVIATION 8.9
15.65 nmol/L
STANDARD_DEVIATION 5.7
Weight83 kilogram
STANDARD_DEVIATION 18
89 kilogram
STANDARD_DEVIATION 22
86 kilogram
STANDARD_DEVIATION 20

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
3 / 86 / 8
serious
Total, serious adverse events
0 / 80 / 8

Outcome results

Primary

Area Under the Curve-Serum T

Time frame: 14 days

ArmMeasureGroupValue (MEAN)Dispersion
Testosterone OnlyArea Under the Curve-Serum Texternal matrix 'immediate' release143 nmol*h/LStandard Error 47
Testosterone OnlyArea Under the Curve-Serum Texternal matrix 'fast' release144 nmol*h/LStandard Error 44
Testosterone OnlyArea Under the Curve-Serum Texternal matrix 'slow' release162 nmol*h/LStandard Error 60
Testosterone Plus FinasterideArea Under the Curve-Serum Texternal matrix 'immediate' release198 nmol*h/LStandard Error 86
Testosterone Plus FinasterideArea Under the Curve-Serum Texternal matrix 'fast' release384 nmol*h/LStandard Error 273
Testosterone Plus FinasterideArea Under the Curve-Serum Texternal matrix 'slow' release237 nmol*h/LStandard Error 141
p-value: <0.05Wilcoxon sign-rank
Secondary

Area Under the Curve-E2

Time frame: 14 Days

ArmMeasureGroupValue (MEAN)Dispersion
Testosterone OnlyArea Under the Curve-E2external matrix 'immediate' release1812 nmol*h/LStandard Deviation 405
Testosterone OnlyArea Under the Curve-E2external matrix 'fast' release1961 nmol*h/LStandard Deviation 528
Testosterone OnlyArea Under the Curve-E2external matrix 'slow' release1944 nmol*h/LStandard Deviation 652
Testosterone Plus FinasterideArea Under the Curve-E2external matrix 'immediate' release2241 nmol*h/LStandard Deviation 783
Testosterone Plus FinasterideArea Under the Curve-E2external matrix 'fast' release2002 nmol*h/LStandard Deviation 861
Testosterone Plus FinasterideArea Under the Curve-E2external matrix 'slow' release3129 nmol*h/LStandard Deviation 1574
Comparison: Area-under-the-curve for serum estradiolp-value: 0.05Wilcoxon (Mann-Whitney)
Secondary

Area Under the Curve-serum DHT

Time frame: 14-days

ArmMeasureGroupValue (MEAN)Dispersion
Testosterone OnlyArea Under the Curve-serum DHTexternal matrix 'immediate' release36 nmol*h/LStandard Error 13
Testosterone OnlyArea Under the Curve-serum DHTexternal matrix 'fast' release42 nmol*h/LStandard Error 21
Testosterone OnlyArea Under the Curve-serum DHTexternal matrix 'slow' release39 nmol*h/LStandard Error 16
Testosterone Plus FinasterideArea Under the Curve-serum DHTexternal matrix 'immediate' release23 nmol*h/LStandard Error 10
Testosterone Plus FinasterideArea Under the Curve-serum DHTexternal matrix 'fast' release26 nmol*h/LStandard Error 12
Testosterone Plus FinasterideArea Under the Curve-serum DHTexternal matrix 'slow' release26 nmol*h/LStandard Error 11
p-value: <0.05Wilcoxon sign-rank

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026