NCT01716104 is a Phase 3 clinical trial of Afalaza in Benign Prostatic Hyperplasia, sponsored by Materia Medica Holding.

Who is sponsoring NCT01716104?

NCT01716104 is sponsored by Materia Medica Holding.

What drugs are being tested in NCT01716104?

Interventions in NCT01716104: Afalaza, Placebo.

What condition does NCT01716104 study?

NCT01716104 studies Benign Prostatic Hyperplasia.

Is NCT01716104 still recruiting?

NCT01716104 is currently completed. Last updated 1 November 2018.

Are results published for NCT01716104?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-11-01 · How we verify

NCT01716104

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression

Completed Phase 3 Results posted Last updated 1 November 2018

What this trial tests

Phase 3 trial testing Afalaza in Benign Prostatic Hyperplasia in 260 participants. Completed in 1 November 2016.

Timeline

1 November 2012

Primary endpoint
1 November 2016

1 November 2016

Quick facts

Lead sponsor	Materia Medica Holding
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	260
Start date	1 November 2012
Primary completion	1 November 2016
Estimated completion	1 November 2016
Sites	16 locations across Russia, Ukraine

Drugs / interventions tested

Afalaza — full drug profile →
Placebo

Conditions studied

Benign Prostatic Hyperplasia — all drugs for Benign Prostatic Hyperplasia →

Sponsor

Materia Medica Holding — full company profile →

Who can join

Adults 45 to 60, male only, with Benign Prostatic Hyperplasia. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline.
Time frame: Baseline, 1, 3, 6 and 12 months
The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in thi

Sponsor's own description

The purpose of this study is: * To assess safety of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia (BPH) and risk of progression. * To assess efficacy of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia and risk of progression.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy and safety of Afalaza in men with symptomatic benign prostatic hyperplasia at risk of progression: a multicenter, double-blind, placebo-controlled, randomized clinical trial.
Pushkar D, Vinarov A, Spivak L, Kolontarev K, et al · · 2018 · cited 7× · PMID 30680237 · DOI 10.5173/ceju.2018.1803

Verify or expand the search:

Other recruiting trials for Benign Prostatic Hyperplasia

Currently open trials in the same condition.

NCT07444385 — A Study to Evaluate the Safety and Pharmacokinetics of AD-116 and AD-1161 in Healthy Adult Male Subjects · Phase 1 · recruiting
NCT07293442 — Pelvic Floor Muscle Exercise for Lower Urinary Tract Symptoms After Surgery for Benign Prostatic Hyperplasia. · NA · recruiting
NCT06657872 — Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial · NA · recruiting
NCT06852859 — Patient-reported Pain and Symptom Relief During Three Months After Surgery for Benign Prostatic Hyperplasia · recruiting
NCT06849258 — A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms · NA · recruiting

Other Materia Medica Holding trials

Trials by the same sponsor.

NCT07171099 — Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children · Phase 3 · recruiting
NCT06901297 — The Efficacy and Safety of Raphamin in the Treatment of Acute Rhinosinusitis in Adult Patients · Phase 3 · recruiting
NCT06715891 — Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of ARVI in Children Aged 3-12 Years · Phase 3 · recruiting
NCT06263881 — Clinical Trial of the Efficacy and Safety of Raphamin in Combined Treatment of Community-acquired Pneumonia · Phase 3 · completed
NCT06284265 — Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis · Phase 3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01716104 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Materia Medica Holding
Last refreshed: 1 November 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01716104.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing