Prostatic Hyperplasia, BenignPhase 3AUSTRÁLIANCT06264414
Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia
A Phase 3 study testing DTT106 and Dutasteride-Tamsulosin in people with Prostatic Hyperplasia, Benign and Erectile Dysfunction, run by EMS at 1 site in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia, Benign, Erectile Dysfunction
- What is being tested?
- DTT106 and Dutasteride-Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2025to Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 28Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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
Read the 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).
- Being tested
- DTT106, Dutasteride-Tamsulosin
- Medical subject headings
- Prostatic Hyperplasia, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTT106Drug
oral route
Dutasteride-TamsulosinDrug
oral route
| Study group | Role | What they receive |
|---|---|---|
| DTT106 | Experimental | 1 hard capsule once a day, consistently 30 minutes after the same meal each day Receives: Drug: DTT106 |
| dutasteride and tamsulosin | Active comparator | 1 hard capsule once a day, consistently 30 minutes after the same meal each day Receives: Drug: Dutasteride-Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 12 weeks
Secondary outcomes (11)
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
Measured: baseline and 12 weeks
Decrease in post-void residual volume (PVR)
Change in post-void residual (PVR) volume, measured through prostate ultrasound
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
Improvement in urinary storage symptoms.
Change in the score of the storage domain of the IPSS (irritative symptoms, questions 2, 4, and 7). 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.
Measured: baseline and 12 weeks
Improvement in the participant's quality of life in relation to their urinary condition
Change in the score of the quality-of-life item of the IPSS (IPSS-QoL). 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.
Measured: baseline and 12 weeks
Improvement in the participant's sexual function
Change in the total IIEF score. The 15-question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment and treatment of erectile dysfunction. It examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. Each question is scored between 0 and 5, resulting in a total score range of 0-75 (higher score = less dysfunction). Higher scores indicate a better outcome.
Measured: baseline and 12 weeks
Improvement in the participant's orgasmic function.
Change in the Orgasmic Function domain of the IIEF (IIEF-OF, questions 9 and 10). The 15-question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment and treatment of erectile dysfunction. It examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. Each question is scored between 0 and 5, resulting in a total score range of 0-75 (higher score = less dysfunction). Higher scores indicate a better outcome.
Measured: baseline and 12 weeks
Effectiveness of the treatment in improving the participant's sexual desire
Change in the Sexual Desire domain of the IIEF (IIEF-SD, questions 11 and 12). The 15-question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment and treatment of erectile dysfunction. It examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. Each question is scored between 0 and 5, resulting in a total score range of 0-75 (higher score = less dysfunction). Higher scores indicate a better outcome.
Measured: baseline and 12 weeks
Effectiveness in improving the participant's satisfaction with sexual relations
Change in the Satisfaction domain of Sexual Intercourse of the IIEF (IIEF-IS, questions 6, 7, and 8). The 15-question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment and treatment of erectile dysfunction. It examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. Each question is scored between 0 and 5, resulting in a total score range of 0-75 (higher score = less dysfunction). Higher scores indicate a better outcome.
Measured: baseline and 12 weeks
Overall satisfaction of the participant regarding their sex life.
Change in the General Satisfaction domain of the IIEF (IIEF-OS, questions 13 and 14). The 15-question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment and treatment of erectile dysfunction. It examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. Each question is scored between 0 and 5, resulting in a total score range of 0-75 (higher score = less dysfunction). Higher scores indicate a better outcome.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study startFeb 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Hyperplasia, BenignStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264414
- Sponsor's protocol ID
- DTT106-III-0123
- Acronym
- AUSTRÁLIA
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06264414
- Acronym / sponsor ID
- AUSTRÁLIA / DTT106-III-0123
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DTT106 | Experimental | Drug: DTT1061 hard capsule once a day, consistently 30 minutes after the same meal each day |
| dutasteride and tamsulosin | Active comparator | Drug: Dutasteride-Tamsulosin1 hard capsule once a day, consistently 30 minutes after the same meal each day |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (28 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTT106oral route | Drug | DTT106 |
| Dutasteride-Tamsulosinoral route | Drug | dutasteride and tamsulosin |
Primary outcome
Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF) at the end of treatment, from baseline.
Time frame: baseline and 12 weeks
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
11 secondary outcomes
Change in maximum urinary flow rate (Qmax)
Time frame: baseline and 12 weeks
Decrease in post-void residual volume (PVR)
Time frame: baseline and 12 weeks
Improvement in urinary symptoms.
Time frame: baseline and 12 weeks
Improvement in urinary emptying symptoms
Time frame: baseline and 12 weeks
Improvement in urinary storage symptoms.
Time frame: baseline and 12 weeks
Improvement in the participant's quality of life in relation to their urinary condition
Time frame: baseline and 12 weeks
Improvement in the participant's sexual function
Time frame: baseline and 12 weeks
Improvement in the participant's orgasmic function.
Time frame: baseline and 12 weeks
Effectiveness of the treatment in improving the participant's sexual desire
Time frame: baseline and 12 weeks
Effectiveness in improving the participant's satisfaction with sexual relations
Time frame: baseline and 12 weeks
Overall satisfaction of the participant regarding their sex life.
Time frame: baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DTT106 and Dutasteride-Tamsulosin in people with Prostatic Hyperplasia, Benign and Erectile Dysfunction, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cassiano Berto (+551938877724, pesquisa.clinica@ncfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Erectile Function domain score of the International Index of Erectile Function (IIEF-EF) at the end of treatment, from baseline. (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.