Efficacy/ Safety of Product DNN.65.21.005 in Patients With Benign Prostatic Hyperplasia
NCT ID: NCT07270432
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE3
218 participants
INTERVENTIONAL
2026-01-31
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment
NCT00090103
(Phosphodiesterase 5 Inhibitors & α-blockers): Single Versus Combined Therapy in Benign Prostatic Hyperplasia
NCT05236634
Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for BPH
NCT04987892
Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia
NCT00969072
Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects
NCT00368979
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Product DNN.65.21.005
Product DNN.65.21.005
One capsule every 24 hours
Combodart®
Combodart®
One capsule every 24 hours
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Product DNN.65.21.005
One capsule every 24 hours
Combodart®
One capsule every 24 hours
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
50 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ache Laboratorios Farmaceuticos S.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACH-DTS-03(03/22)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.