NCT05381831

Natesto Spermatogenesis Reboot

The Effects of Intranasal Testosterone (NatestoTM) for Treatment of Hypogonadism on Maintenance of Spermatogenesis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, non-blinded study of hypogonadal men with a history of testosterone therapy who became azoospermic or severely oligospermic and wish to avoid symptoms of hypogonadism during their recovery of spermatogenesis in an effort to establish paternity. The study will determine if Natesto can alleviate hypogonadal symptoms while preserving the recovery of spermatogenesis

Conditions

• Hypogonadism, Male

Interventions

Type	Name	Description
DRUG	NatestoTM	Administering daily intranasal testosterone, Natesto nasal gel is available as a metered-dose pump. One pump actuation delivers 5.5 mg of testosterone

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-04-21
• Completion: 2025-04-21
• First posted: 2022-05-19
• Last updated: 2025-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study