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Prostatic Hyperplasia Treatment and Cancer Prevention

Primary Purpose

Prostatic Hyperplasia

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
papaverine
Sponsored by
Manchanda Medical Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    group two- papaverine arm

    Arm Description

    Drug free base as placebo

    papaverine in a suitable base

    Outcomes

    Primary Outcome Measures

    Laboratory tests to measure regression of symptoms
    patients follow-up on regular intervals

    Secondary Outcome Measures

    Full Information

    First Posted
    December 12, 2016
    Last Updated
    February 24, 2021
    Sponsor
    Manchanda Medical Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03064282
    Brief Title
    Prostatic Hyperplasia Treatment and Cancer Prevention
    Official Title
    Treatment of Prostatic Hyperplasia With Topical Papaverine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 30, 2021 (Anticipated)
    Primary Completion Date
    September 30, 2021 (Anticipated)
    Study Completion Date
    December 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Manchanda Medical Clinic

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostatic Hyperplasia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Drug free base as placebo
    Arm Title
    group two- papaverine arm
    Arm Type
    Experimental
    Arm Description
    papaverine in a suitable base
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    drug free base
    Intervention Description
    observation of skin changes if any
    Intervention Type
    Drug
    Intervention Name(s)
    papaverine
    Intervention Description
    observation of symptoms
    Primary Outcome Measure Information:
    Title
    Laboratory tests to measure regression of symptoms
    Description
    patients follow-up on regular intervals
    Time Frame
    every 4 weeks up to 16 weeks

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    14761837
    Citation
    Hafez B, Hafez ES. Andropause: endocrinology, erectile dysfunction, and prostate pathophysiology. Arch Androl. 2004 Mar-Apr;50(2):45-68.
    Results Reference
    background

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    Prostatic Hyperplasia Treatment and Cancer Prevention

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