Phase 2 Completed N=15 Treatment

Pharmacokinetic Study to Determine Time to Steady-state

Male hypogonadism · Primary Hypogonadism · Secondary Hypogonadism

Source: ClinicalTrials.gov NCT00911586 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcomePrimary: Serum T Concentration at Steady State — -4.077 ng/dL — p=0.8060

Summary

The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum T Concentration at Steady State	-4.077	0.8060
PRIMARY Serum T Concentration at Steady-State	4.114	0.8286

Eligibility Criteria

Inclusion Criteria

Male, age 18-75
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 (NCT00911586). 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.