Prostatic Hyperplasia Treatment and Cancer Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03064282
Recruitment Status : Not yet recruiting
First Posted : February 27, 2017
Last Update Posted : August 15, 2018
Information provided by (Responsible Party):
DR. VINOD C TAWAR, Manchanda Medical Clinic

Brief Summary:
Treatment of patients with prostatic hyperplasia with topical papaverine.

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Other: Placebo Drug: papaverine Early Phase 1

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Prostatic Hyperplasia With Topical Papaverine
Estimated Study Start Date : October 30, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Drug free base as placebo
Other: Placebo
observation of skin changes if any
Other Name: drug free base

Experimental: group two- papaverine arm
papaverine in a suitable base
Drug: papaverine
observation of symptoms

Primary Outcome Measures :
  1. Laboratory tests to measure regression of symptoms [ Time Frame: every 4 weeks up to 16 weeks ]
    patients follow-up on regular intervals

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Responsible Party: DR. VINOD C TAWAR, Principal Investigator, Manchanda Medical Clinic Identifier: NCT03064282     History of Changes
Other Study ID Numbers: Tawar - 2
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Prostatic Hyperplasia
Prostatic Diseases
Pathologic Processes
Genital Diseases, Male
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Urological Agents