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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
DTT106
Drugoral route
Dutasteride-Tamsulosin
Drugoral route
Treatment groups
262 Participants
are divided into 2 treatment groupsGroup A: DTT106Experimental treatment 1 intervention
Group B: dutasteride and tamsulosinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF) at the end of treatment, from baseline.
The IIEF (International Index of Erectile Function) is a quantitative measure used in the diagnostic assessment of erectile dysfunction. The IIEF is the sum of the scores assigned to each question, with scores ranging from 1 to 5, where 1=never and 5=always. The questionnaire covers five domains
Time frame
baseline and 12 weeksSecondary outcomes
1
Change in maximum urinary flow rate (Qmax)
The maximum urinary flow rate (Qmax) will be measured by a flowmeter, compared to the baseline value, at the end of treatment
Time frame
baseline and 12 weeks2
Decrease in post-void residual volume (PVR)
Change in post-void residual (PVR) volume, measured through prostate ultrasound
Time frame
baseline and 12 weeks3
Improvement in urinary symptoms.
Change in the total International Prostate Symptom Score (IPSS) in patients.The IPSS relies upon the responses to seven questions regarding urinary symptoms and one question related to the patient's quality of life. Each question about urinary symptoms allows the patient to select one of six responses indicating the severity of the particular symptom. These responses are assigned points from 0 to 5. Consequently, the total score can vary from 0 to 35, with higher scores representing more severe symptoms. A higher score on the IPSS implies a poorer outcome.
Time frame
baseline and 12 weeks4
Improvement in urinary emptying symptoms
Change in the score of the emptying domain of the IPSS (obstructive symptoms, questions 1, 3, 5, and 6). The IPSS relies upon the responses to seven questions regarding urinary symptoms and one question related to the patient's quality of life. Each question about urinary symptoms allows the patient to select one of six responses indicating the severity of the particular symptom. These responses are assigned points from 0 to 5. Consequently, the total score can vary from 0 to 35, with higher scores representing more severe symptoms. A higher score on the IPSS implies a poorer outcome.
Time frame
baseline and 12 weeks Source ClinicalTrials.gov
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