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Testosterone Therapy for Late-Onset Hypogonadism: A Clinical, Biological, and Analytical Approach Using Compounded
Daniel Banov1, Bruce Biundo1, Kendice Ip1
1Professional Compounding Centers of America (PCCA), Houston, TX 77099, USA.
Pharmaceutics
|May 25, 2024
Summary
Topical testosterone gel effectively treats hypogonadal symptoms in aging men, improving testosterone levels. Compounded formulations demonstrate stability and skin permeation, offering a promising personalized therapy option.
Area of Science:
- Endocrinology
- Dermatology
- Pharmaceutical Sciences
Background:
- Testosterone is crucial for male health, declining with age.
- Hypogonadism presents symptoms that impact quality of life.
- Topical testosterone offers a therapeutic route for hormone replacement.
Purpose of the Study:
- To assess the clinical efficacy and stability of compounded topical testosterone gel.
- To evaluate testosterone's skin permeation characteristics.
- To determine the suitability of topical testosterone for long-term hypogonadism management.
Main Methods:
- Retrospective analysis of a patient receiving 5% compounded testosterone gel.
- Evaluation of serum total testosterone levels and androgen deficiency questionnaire results.
- In vitro skin permeation studies using the Franz finite dose model and human cadaver skin.
- Analytical testing for stability-indicating assay methods for 0.5% and 20% testosterone gels.
Main Results:
- The patient experienced improved hypogonadal symptoms and achieved optimal serum testosterone levels.
- In vitro studies confirmed testosterone penetration through human cadaver skin.
- Compounded testosterone gels (0.5% and 20%) exhibited extended stability.
Conclusions:
- Topical testosterone gel is clinically effective for alleviating hypogonadal symptoms.
- Compounded topical testosterone formulations are stable and demonstrate adequate skin permeation.
- Personalized topical testosterone therapy is a viable therapeutic option for hypogonadal patients.
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