NCT06264414

Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia

Phase III, Multicenter, Randomized, Double-blind Clinical Trial to Assess the Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 262 (estimated)
• Sponsor: EMS · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of the DTT106 in the treatment of erectile dysfunction associated with benign prostatic hyperplasia

Detailed description

After being informed about all risks and benefits and giving written informed consent, the subjects will undergo a 7-day screening to determine eligibility. After that, at visit 0 (V0), the subjects will be randomized to either the DTT106 or dutasteride + tamsulosin (0,5 mg + 0,4 mg).

Conditions

• Prostatic Hyperplasia, Benign
• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	DTT106	oral route
DRUG	Dutasteride-Tamsulosin	oral route

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-06-01
• Completion: 2027-07-01
• First posted: 2024-02-20
• Last updated: 2024-02-20

Locations

1 site across 1 country: Brazil