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Testosterone Undecanoate and/or PDE-5
Testosterone undecanoate replaces deficient testosterone while PDE-5 inhibitors enhance erectile function by increasing nitric oxide signaling in penile vasculature.
Testosterone undecanoate replaces deficient testosterone while PDE-5 inhibitors enhance erectile function by increasing nitric oxide signaling in penile vasculature. Used for Hypogonadism with erectile dysfunction, Testosterone deficiency in adult males.
At a glance
| Generic name | Testosterone Undecanoate and/or PDE-5 |
|---|---|
| Also known as | Nebido, Levitra |
| Sponsor | Hospital Santa Fe |
| Drug class | Androgen replacement therapy combined with PDE-5 inhibitor |
| Target | Androgen receptor (testosterone undecanoate); phosphodiesterase-5 (PDE-5 inhibitor component) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Urology |
| Phase | FDA-approved |
Mechanism of action
Testosterone undecanoate is a long-acting androgen replacement therapy that restores physiological testosterone levels in hypogonadal men. PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) block phosphodiesterase-5 enzyme, preventing degradation of cGMP and promoting smooth muscle relaxation and vasodilation in the corpus cavernosum. The combination addresses both hormonal deficiency and erectile dysfunction.
Approved indications
- Hypogonadism with erectile dysfunction
- Testosterone deficiency in adult males
Common side effects
- Headache
- Flushing
- Dyspepsia
- Nasal congestion
- Polycythemia
- Gynecomastia
- Acne
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Testosterone Undecanoate and/or PDE-5 CI brief — competitive landscape report
- Testosterone Undecanoate and/or PDE-5 updates RSS · CI watch RSS
- Hospital Santa Fe portfolio CI