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Phase 1 N=16 Treatment

ORAL T-6: Oral Androgens in Man-6

Contraception · Hypogonadism

Bottom Line

View on ClinicalTrials.gov: NCT00663793 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcome: Primary: Area Under the Curve-Serum T — 143; 198; 144; 384 nmol*h/L — p=<0.05

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
Acyline (Drug); Testosterone (Drug); Finasteride (Drug)
Age
Adult · 18+ yrs
Sex
Male
Sponsor
University of Washington
Primary completion
May 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Area Under the Curve-Serum T		 143; 198; 144; 384; 162; 237 <0.05 sig
SECONDARY
Area Under the Curve-serum DHT		 36; 23; 42; 26; 39; 26 <0.05 sig
SECONDARY
Area Under the Curve-E2		 1812; 2241; 1961; 2002; 1944; 3129 0.05

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00663793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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