Prostatic Hyperplasia, BenignPhase 3NICCOLONCT07270432
Efficacy/ Safety of Product DNN.65.21.005 in Patients With Benign Prostatic Hyperplasia
A Phase 3 study testing Product DNN.65.21.005 and Combodart® in people with Prostatic Hyperplasia, Benign, run by Ache Laboratorios Farmaceuticos S.A..
Trial summary
To evaluate the safety and efficacy of DNN.65.21.005 versus Combodart® in the treatment of benign prostatic hyperplasia Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia, Benign
- What is being tested?
- Product DNN.65.21.005 and Combodart®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Apr 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male participants aged 50 years and older.
- Ability to understand the study and provide informed consent, documented by signing the Informed Consent Form (ICF).
- Participants presenting lower urinary tract symptoms (LUTS) associated with prostate enlargement, without neurological or infectious causes.
Who cannot join
- History or evidence of prostate cancer.
- Urinary retention ≥100 mL, as assessed by abdominal prostate ultrasound.
- Previous diagnosis of Parkinson's disease or other neurological disorders that may lead to neurogenic bladder.
- Use of herbal treatments for prostate enlargement within 14 days prior to the screening visit.
- Current use or use of alpha-blocker medications within 7 days prior to the start of study treatment.
- Current use or use of 5-alpha reductase inhibitors (5ARIs) within 180 days prior to the start of study treatment.
- Use of any prohibited medications within the timeframe specified in the study protocol.
- Any clinical findings or observations (clinical or physical evaluation) that, in the investigator's judgment, pose a risk to participation in the study.
About this study
Official title: Randomized Clinical Trial to Evaluate the Safety and Efficacy of Product DNN.65.21.005 in Alleviating Lower Urinary Tract Symptoms in Patients With Benign Prostatic Hyperplasia
To evaluate the safety and efficacy of DNN.65.21.005 versus Combodart® in the treatment of benign prostatic hyperplasia
- Conditions
- Prostatic Hyperplasia, Benign
- Being tested
- Product DNN.65.21.005, Combodart®
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product DNN.65.21.005Drug
One capsule every 24 hours
Combodart®Drug
One capsule every 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Product DNN.65.21.005 | Experimental | Not described Receives: Drug: Product DNN.65.21.005 |
| Combodart® | Active comparator | Not described Receives: Drug: Combodart® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Prostate Symptom Score (IPSS)
Change in International Prostate Symptom Score (IPSS) evaluated 180 days after starting treatment compared to the baseline
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270432
- Sponsor's protocol ID
- ACH-DTS-03(03/22)
- Acronym
- NICCOLO
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Safety and Efficacy of Product DNN.65.21.005 in Alleviating Lower Urinary Tract Symptoms in Patients With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT07270432
- Acronym / sponsor ID
- NICCOLO / ACH-DTS-03(03/22)
- Conditions
- Prostatic Hyperplasia, Benign
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Dec 2025 (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.
To evaluate the safety and efficacy of DNN.65.21.005 versus Combodart® in the treatment of benign prostatic hyperplasia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Product DNN.65.21.005 | Experimental | Drug: Product DNN.65.21.005 |
| Combodart® | Active comparator | Drug: Combodart® |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male participants aged 50 years and older.
- Ability to understand the study and provide informed consent, documented by signing the Informed Consent Form (ICF).
- Participants presenting lower urinary tract symptoms (LUTS) associated with prostate enlargement, without neurological or infectious causes.
Key exclusion criteria (8 listed)
- History or evidence of prostate cancer.
- Urinary retention ≥100 mL, as assessed by abdominal prostate ultrasound.
- Previous diagnosis of Parkinson's disease or other neurological disorders that may lead to neurogenic bladder.
- Use of herbal treatments for prostate enlargement within 14 days prior to the screening visit.
- Current use or use of alpha-blocker medications within 7 days prior to the start of study treatment.
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 |
|---|---|---|
| Product DNN.65.21.005One capsule every 24 hours | Drug | Product DNN.65.21.005 |
| Combodart®One capsule every 24 hours | Drug | Combodart® |
Primary outcome
Change in International Prostate Symptom Score (IPSS)
Time frame: 180 days
Change in International Prostate Symptom Score (IPSS) evaluated 180 days after starting treatment compared to the baseline
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 8 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Product DNN.65.21.005 and Combodart® in people with Prostatic Hyperplasia, Benign, run by Ache Laboratorios Farmaceuticos S.A..
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 3 inclusion and 8 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 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (IPSS) (time frame: 180 days). 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 8 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.