Clinical trial NCT06264414: Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Prostatic Hyperplasia, Benign
Erectile Dysfunction
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 262
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Primary outcomes:
measure: Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF) at the end of treatment, from baseline.
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change in maximum urinary flow rate (Qmax)
timeFrame: baseline and 12 weeks
measure: Decrease in post-void residual volume (PVR)
timeFrame: baseline and 12 weeks
measure: Improvement in urinary symptoms.
timeFrame: baseline and 12 weeks
measure: Improvement in urinary emptying symptoms
timeFrame: baseline and 12 weeks
measure: Improvement in urinary storage symptoms.
timeFrame: baseline and 12 weeks
measure: Improvement in the participant's quality of life in relation to their urinary condition
timeFrame: baseline and 12 weeks
measure: Improvement in the participant's sexual function
timeFrame: baseline and 12 weeks
measure: Improvement in the participant's orgasmic function.
timeFrame: baseline and 12 weeks
measure: Effectiveness of the treatment in improving the participant's sexual desire
timeFrame: baseline and 12 weeks
measure: Effectiveness in improving the participant's satisfaction with sexual relations
timeFrame: baseline and 12 weeks
measure: Overall satisfaction of the participant regarding their sex life.
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Hortolândia
country: Brazil
facility: EMS
state: São Paulo
Study officials:
References: