NCT03064282

Brief Summary

Treatment of patients with prostatic hyperplasia with topical papaverine.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jun 2021

Shorter than P25 for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
4.3 years until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

December 12, 2016

Last Update Submit

February 24, 2021

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Laboratory tests to measure regression of symptoms

    patients follow-up on regular intervals

    every 4 weeks up to 16 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug free base as placebo

Other: Placebo

group two- papaverine arm

EXPERIMENTAL

papaverine in a suitable base

Drug: papaverine

Interventions

PlaceboOTHER

observation of skin changes if any

Also known as: drug free base
Placebo
papaverineDRUG

observation of symptoms

group two- papaverine arm

Eligibility Criteria

Age50 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hafez B, Hafez ES. Andropause: endocrinology, erectile dysfunction, and prostate pathophysiology. Arch Androl. 2004 Mar-Apr;50(2):45-68.

    PMID: 14761837BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Papaverine

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BenzylisoquinolinesAlkaloidsHeterocyclic CompoundsOpiate AlkaloidsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 12, 2016

First Posted

February 27, 2017

Study Start

June 30, 2021

Primary Completion

September 30, 2021

Study Completion

December 1, 2021

Last Updated

February 25, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share