Phase 2
Completed N=29
Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men
Source: ClinicalTrials.gov NCT00695110 ↗Enrolled (actual)
29
Serious AEs
3.5%
Results posted
Jun 2021
Primary outcomePrimary: Serum Testosterone Average Concentration (Cavg) (ng/dL) — 792; 654; 541; 765 ng/dL
Summary
The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Testosterone Average Concentration (Cavg) (ng/dL) |
792; 654; 541; 765; 657; 518 | — |
| PRIMARY Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL) |
19009; 15693; 12980; 9179; 7881; 6217 | — |
Eligibility Criteria
Inclusion Criteria
- Male, ages 18-68
- Serum total T less than or equal to 275 ng/dL
Exclusion Criteria
- Significant intercurrent disease of any type, in particular, liver, kidney or heart disease, uncontrolled diabetes mellitus or psychiatric illness.
- Abnormal prostate digital rectal examination, elevated prostate-specific antigen (PSA), American Urological Association (AUA) symptom score of >15, and/or history of prostate cancer.
- Hematocrit of 50%
- Body mass index (BMI) >36
- Serum transaminases > 2 times upper limit of normal or serum bilirubin > 2.0 mg/dL
Data sourced from ClinicalTrials.gov (NCT00695110). 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.