Phase 2 Completed N=16 Randomized Treatment

Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

Source: ClinicalTrials.gov NCT00924612 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcomePrimary: Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet — 6.38; 6.73; 6.88; 7.00 ng/dL — p=0.0025

Summary

The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean T Cavg25 Following Meals Containing Various Amounts of Dietary Fat Compared to Normal Fat Diet	6.38; 6.73; 6.88; 7.00; 7.18	0.0025 sig

Eligibility Criteria

Inclusion Criteria

Male
Age 18-65
Morning serum testosterone (T) 15 or history of prostate cancer.
Serum transaminases >2 times upper limit of normal
Serum bilirubin >2.0 mg/dL
Hematocrit 50%
BMI >36
Untreated, obstructive sleep apnea.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00924612). 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. Informational only — not medical advice.