Estrogen and Platelet Rich Plasma in Treatment of Atrophic Vaginitis

Last updated: April 27, 2023
Sponsor: Fayoum University
Overall Status: Active - Recruiting

Phase

1

Condition

Vaginitis

Vaginal Atrophy

Treatment

platelet rich plasma

Conjugated Estrogens vaginal cream 0,625mg

Clinical Study ID

NCT05118685
R 180
  • Ages 50-70
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • postmenopausal women aged 50-70 years old
  • with a clinical diagnosis of vaginal atrophy who will not need systemic estrogentherapy for the treatment of vasomotor symptoms or prophylaxis of osteoporosis
  • Any parity.

Exclusion

Exclusion Criteria:

  • Women with any history of carcinoma of the breast or endometrium,
  • abnormal genital bleeding, acute thrombophlebitis, or thromboembolic disordersassociated with previous estrogen use,
  • or current urinary.
  • In addition, women who underwent hormone replacement therapy, treated with systemic orvaginal estrogen within 6 months prior to the study,
  • or had any contraindication for estrogen therapy will be excluded from the study.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: platelet rich plasma
Phase: 1
Study Start date:
November 13, 2021
Estimated Completion Date:
September 30, 2023

Study Description

Oestrogen deficiency affects many organs such as the genitourinary system. Genitourinary involvement causes untoward symptoms of atrophic vaginitis including dryness, burning, dyspareunia, vulvar pruritus, and discharge For this reason, many investigations have been performed to find out effective, safe, and acceptable therapeutic methods for atrophic vaginitis. Although systemic administration of estrogen can improve the localized symptoms of atrophic vaginitis, women are often reluctant to use systemic hormone replacement therapy and prefer local administration of estrogen. Vaginal application of estrogen has been considered an effective treatment of atrophic vaginitis.

The effects of PRP treatment have been evaluated in many clinical conditions, including wound healing, hair repair, skin regeneration [9], vulvar lichen sclerosis, stress urinary incontinence, episiotomy scars, and lubrication aging in the vagina. It can take at least 12 weeks to determine the final effects of treatment with PRP Population of Study It includes 100 pt. complaining of atrophic vaginitis it will be divided into two groups, each group will contain 50 pt

Methodology in detail:

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

The second group will receive PRP injection every 3 weeks for 4 times. 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 clitoris or the anterior wall of the vagina to increase the tactile sensitivity of the injection site.

Connect with a study center

  • Fayoum university faculity of medicine

    Fayoum, Fayoum University Zone 63514
    Egypt

    Active - Recruiting

  • Fayoum university

    Fayoum, 63514
    Egypt

    Site Not Available

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