A Phase 3 interventional study of Product DNN.65.21.005 and Combodart® in Prostatic Hyperplasia, Benign, sponsored by Ache Laboratorios Farmaceuticos S.A.. Not yet recruiting. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Ache Laboratorios Farmaceuticos S.A. · Phase 3, Interventional, and Treatment
To evaluate the safety and efficacy of DNN.65.21.005 versus Combodart® in the treatment of benign prostatic hyperplasia
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 218 is above the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Ache Laboratorios Farmaceuticos S.A. is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Product DNN.65.21.005
Drug: Combodart®
One capsule every 24 hours
One capsule every 24 hours
Change in International Prostate Symptom Score (IPSS)
Change in International Prostate Symptom Score (IPSS) evaluated 180 days after starting treatment compared to the baseline
Time frame: 180 days
No study locations are listed for this record.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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