Efficacy and Safety of the DTT106 in the Treatment of Ere... | NCT06264414

NCT06264414

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
DTT106	Experimental	1 hard capsule once a day, consistently 30 minutes after the same meal each day	Drug: DTT106
dutasteride and tamsulosin	Active Comparator	1 hard capsule once a day, consistently 30 minutes after the same meal each day	Drug: Dutasteride-Tamsulosin

Name	Type	Description	Arm Group Labels	Other Names
DTT106	Drug	oral route	DTT106
Dutasteride-Tamsulosin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	baseline and 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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	baseline and 12 weeks
Decrease in post-void residual volume (PVR)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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);
Erectile Function domain score of IIEF ≤ 25 and ≥ 6 points at the time of screening.

Exclusion Criteria:

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;
Known allergy or hypersensitivity to the components of the medicinal products used during the clinical trial;
History of pelvic surgery, prostatectomy, radiation therapy, penile implant placement surgery, urinary tract trauma, or invasive procedures for BPH treatment.
Diagnosis of other diseases or conditions in the urinary tract, including, but not limited to: cancer, neurogenic bladder, urinary incontinence, recurrent infection, urethral stenosis, bacterial prostatitis.
Clinical evidence of prostate cancer;
Severe renal failure;
Severe liver failure;
Hypogonadism (supported by values below normal, as established by the local laboratory, for total testosterone) or absent libido (sex drive);
Severe psychiatric or psychosocial disorders;
Primary erectile dysfunction;
Polyneuropathy, neurodegenerative diseases, spinal cord trauma or injury, tumors in the central nervous system, or other conditions that may affect erections;
History of orthostatic hypotension.
Expected to undergo cataract or glaucoma surgery;
Concomitant use of any form of organic nitrate;
Concomitant use of guanylate cyclase stimulators such as riociguat;
Anatomical deformation of the penis that can significantly impair erection, including, but not limited to: angulation, cavernous fibrosis, and Peyronie's disease.
Conditions that may predispose to priapism, including but not limited to: sickle cell anemia, multiple myeloma, leukemia;
Prior diagnosis of pulmonary hypertension;
Presence of anterior ischemic optic neuropathy, or degenerative diseases of the retina, including retinitis pigmentosa;
Diagnosis of dysautonomia.
Cardiovascular disease for which sexual activity is inadvisable, including but not limited to: Myocardial infarction in the last 90 days; Unstable angina or angina that occurs during sexual intercourse; Class 2 or higher heart failure according to the New York Heart Association in the last 6 months; Arrhythmias not controlled; Hypotension (< 90/50 mmHg) or uncontrolled hypertension; Stroke in the last six months.
Diabetics with HbA1c greater than or equal to 10%, or with a history of retinopathy and/or neuropathy;
Use of prohibited medications as per the protocol;
Erectile dysfunction that has not responded to phosphodiesterase inhibitors type 5 (including but not limited to: sildenafil, tadalafil, vardenafil) at the time of screening.
Participation in clinical trial protocols within the last 12 (twelve) months.

ID	Term
D011470	Prostatic Hyperplasia
D007172	Erectile Dysfunction

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases