Prostatic Hyperplasia Treatment and Cancer Prevention

Early Phase 1

• Conditions: Prostatic Hyperplasia
• Interventions: Other: Placebo; Drug: papaverine

• Registration Number: NCT03064282
• Lead Sponsor: Manchanda Medical Clinic

Brief Summary

Treatment of patients with prostatic hyperplasia with topical papaverine.

Detailed Description

Patients with obstructive voiding and high PSA to be studied for the regression of symptoms and declining PSA.

Study Timeline

• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-24
• Last Update Posted: 2021-02-25
• Study Start: 2021-06-30
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• patients with symptoms e.g. obstructive voiding, hyperplasia and high PSA

Exclusion Criteria

• patients on chemotherapy
• abnormal lab values e.g. liver function, GFR and CAD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Drug free base as placebo
group two- papaverine arm	papaverine	papaverine in a suitable base

Primary Outcome Measures

Name	Time	Method
Laboratory tests to measure regression of symptoms	every 4 weeks up to 16 weeks	patients follow-up on regular intervals