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Estrogen and Platelet Rich Plasma in Treatment of Atrophic Vaginitis

NCT05118685 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-05-01

No results posted yet for this study

Summary

This study is designed to compare the efficacy, acceptability, and safety of vaginal estrogen cream and platelet-rich plasma in pt. complaining of atrophic vaginitis.

Conditions

  • Atrophic Vaginitis
  • Postmenopausal Atrophic Vaginitis

Interventions

DRUG

Conjugated Estrogens vaginal cream 0,625mg

the particepant will receive vaginal estrogen cream one tube every night for 14 nights; then, one tube for 2 nights in 1 week (two tubes every week) for 10 weeks.

COMBINATION_PRODUCT

platelet rich plasma

First, a topical anesthetic cream will be applied to the vaginal wall. Delaying the PRP injection for 20 minutes after anesthetics application achieved complete or near-complete analgesia for the procedure. Peripheral blood will be drawn from the arm and centrifuged to yield 5 cc of PRP. then PRP will be administered to the anterior vaginal wall using 27-G needles once every 3 weeks for 4 times and PRP is mainly injected into the anterior wall of the vagina to increase the tactile sensitivity of the injection site.

Sponsors & Collaborators

  • Fayoum University

    lead OTHER

Principal Investigators

  • rehab A aboshama, lectuer · Fayoum University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-13
Primary Completion
2023-08-31
Completion
2023-09-30

Countries

  • Egypt

Study Locations

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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 NCT05118685 on ClinicalTrials.gov