Efficacy, Pharmacokinetics and Safety of Testosterone
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | June 2011 |
| End Date: | July 2011 |
A Phase 2 Open-label, Sequential Dose Escalation Study to Evaluate the Efficacy, Pharmacokinetics and Safety of Three Volumes of Topical Testosterone in Hypogonadal Males
This is an open-label study of a single and repeated application of three dose levels of
topical testosterone in hypogonadal males with morning serum T concentrations < 297 ng/dL.
topical testosterone in hypogonadal males with morning serum T concentrations < 297 ng/dL.
Inclusion Criteria:
- Ages 18-65
- History of hypogonadism
- In good health based on medical history, physical examination and clinical laboratory
tests
- Screening morning serum testosterone deficiency (i.e. fatigue, reduced libido or
reduced sexual functioning of non-vasculogenic or neurogenic nature)
- Body mass index (BMI) between 18 and 31
Exclusion Criteria:
- Prostate cancer
- Palpable prostatic mass(es)
- Generalized skin irritation or significant skin disease
- Use of any medications that could be considered anabolic (e.g. dehydroepiandrosterone
(DHEA)) or could interfere with androgen metabolism (e.g. spironolactone,
finasteride, ketoconazole)
- Clinically significant anemia or renal dysfunction
- Hyperparathyroidism or uncontrolled diabetes
- Serum PSA Levels; > 4ng/mL
- History of cardiovascular disease
- Use of estrogens, GnRH agonists/antagonist, human GH (growth hormone), (within
previous 12 months)
- Use of testosterone products (within 8 months for parenteral products, or 6 weeks for
other preparations)
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