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Vaginal Biorevitalization With Polydeoxyribonucleotides for the Improvement of the Genitourinary Syndrome of Menopause

NCT05464654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2023-04-11

No results posted yet for this study

Summary

The aim of the study was to compare the efficacy of vaginal biorevitalization to improve the genitourinary syndrome of menopause (GSM) between the gold-standard treatment with local estrogen-based hormone therapy versus local salmon polydeoxyribonucleotide (PDRN) therapy.

Conditions

  • Genitourinary Syndrome of Menopause
  • Postmenopausal Disorder
  • Menopause
  • Vagina Atrophy

Interventions

DRUG

3 g Polynucleotide vaginal suppositories

3 g polynucleotide vaginal suppositories were administered nightly for 6 days.

DRUG

Conjugated estrogens cream 1g Tube

Conjugated estrogen cream 1g was applied intravaginally on Monday, Wednesday and Friday for three months.

Sponsors & Collaborators

  • Hospital General Regional No. 1 IMSS

    collaborator OTHER_GOV

  • Universidad Nacional Autonoma de Mexico

    collaborator OTHER

  • National Polytechnic Institute, Mexico

    collaborator OTHER

  • Hospital Regional 1o de Octubre

    lead OTHER

Principal Investigators

  • Juan M Ocampo-Godinez, M.D., Ph.D. · Laboratorio de Bioingenieria de Tejidos, UNAM

  • Patricia Loranca-Moreno, M.D., M.Sc. · Hospital Regional 1o de Octubre, ISSSTE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-23
Primary Completion
2021-11-23
Completion
2022-12-31

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05464654 on ClinicalTrials.gov