Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age40+
SponsorEMS
About this trial
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
Eligibility criteria
Qualifiers
men aged 40 years and older.
Sexually active men, with a defined partner, who have engaged in an average of 1 attempt at sexual intercourse per week in the last month.
Participants under stable treatment with dutasteride + tamsulosin combination therapy.
Diagnosis of erectile dysfunction, according to criteria established by the Guideline of the Brazilian Society of Urology and the American Society of Urology (2017);
Disqualifiers
Any clinical or physical observation noted during evaluation by the investigating physician, or any laboratory condition, which is interpreted as posing a risk to participation in the clinical trial;
Presence of uncontrolled chronic diseases;
History of alcohol or illicit drug use disorder within the past 2 years;
Men who are planning to impregnate their partners, or fertile men who are not using a reliable contraceptive method;
Trial design
Treatments tested in this trial
- DTT106
- Dutasteride-Tamsulosin
Treatment groups
262 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov