Estrogen and Platelet Rich Plasma in Treatment of Atrophic Vaginitis

Sponsor
Fayoum University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05118685
Collaborator
(none)
100
2
2
5.6
50
9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Conjugated Estrogens vaginal cream 0,625mg
  • Combination Product: platelet rich plasma
Phase 1

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a randomized clinical trial that will be performed in a Fayoum university hospital. It includes 100 pt. complaining of atrophic vaginitis it will be divided into two groups, each group will contain 50 ptThis is a randomized clinical trial that will be performed in a Fayoum university hospital. It includes 100 pt. complaining of atrophic vaginitis it will be divided into two groups, each group will contain 50 pt
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Comparative Study of Vaginal Oestrogen Cream and Platelet Rich Plasma in Treatment of Atrophic Vaginitis in Fayoum University Hospital
Actual Study Start Date :
Nov 13, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: the first group estrogen group

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

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.
Other Names:
  • Premarin cream
  • Experimental: the second group PRP group

    they will receive a Platelet-rich plasma injection every 3 weeks for 4 times. PRP will be administered to the anterior vaginal wall using 27-G needles o and it is mainly injected into the anterior wall of the vagina to increase the tactile sensitivity of the injection site.

    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.

    Outcome Measures

    Primary Outcome Measures

    1. improvement in Vaginal Health Index (VHI). [12 weeks]

      Vaginal Health Index (VHI) will be assessed at weeks 0, 4, 8 and 12. VHI analyzes the following five components on a scale of 1 to 5: elasticity, fluid volume, pH, epithelial integrity, and moisture.A minimal total score of 5 points indicates severe VVA, and a maximal total score of 25 points indicates no clinical signs of VVA

    2. improvement in Vulvovaginal atrophy (VVA) symptoms using the Visual analog scale (VAS). [12 week]

      Vulvovaginal atrophy (VVA) will be assessed at weeks 0, 4, 8 and 12. Participants will report intensity of VVA symptoms using a 10-cm VAS. The scale's left extremity indicates the complete absence of symptoms (0) and the right extremity indicates the worst possible symptom (10). Participants rated VVA symptoms (dyspareunia, dryness, or burning) from 0 to 10.

    3. Assessment of quality of sexual function using the validated Portuguese version of the Female Sexual Function Index (FSFI) [12 week]

      The FSFI will be assessed at weeks 0,4 ,8 and 12 BY FSFI questionnaire addresses six different domains (desire, arousal, lubrication, orgasm, satisfaction, and pain/ discomfort) ranging from 0 (no sexual activity in the past 4 wk) or 1 (very dissatisfied) to 5 (very satisfied). Full scale scores ranging from 2.0 (severe dysfunction) to 36.0 (absence of dysfunction) will be used to evaluate sexual function throughout the study, with increased FSFI scores correlating to an improvement of symptoms. An optimal cut score of 26, reported by Wiegel etal, is currently used to differentiate between women with and without sexual dysfunction.

    Secondary Outcome Measures

    1. Assessment of tolerability and safety of Platelet rich plasma (PRP). [12 weeks]

      it is measured by the rate of "dropouts", or patients that forfeit participation in a study due to adverse effects (pain during application of the medication, vaginal infection, haematoma formation at site of injection, vaginal spotting, vaginal leakage of the medication and need to use sanitary towels to clean leakage

    2. Assessment of tolerability and safety of estrogen vaginal cream [12 weeks]

      it is measured by the rate of "dropouts", or patients that forfeit participation in a study due to adverse effects (pain during application of the medication .vaginal spotting, vaginal leakage of the medication and need to use sanitary towels to clean leakage

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • postmenopausal women aged 50-70 years old

    • with a clinical diagnosis of vaginal atrophy who will not need systemic estrogen therapy for the treatment of vasomotor symptoms or prophylaxis of osteoporosis

    • Any parity.

    Exclusion Criteria:
    • Women with any history of carcinoma of the breast or endometrium,

    • abnormal genital bleeding, acute thrombophlebitis, or thromboembolic disorders associated with previous estrogen use,

    • or current urinary.

    • In addition, women who underwent hormone replacement therapy, treated with systemic or vaginal estrogen within 6 months prior to the study,

    • or had any contraindication for estrogen therapy will be excluded from the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fayoum university faculity of medicine Fayoum Fayoum University Zone Egypt 63514
    2 Fayoum university Fayoum Egypt 63514

    Sponsors and Collaborators

    • Fayoum University

    Investigators

    • Principal Investigator: rehab A aboshama, lectuer, Fayoum University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    rehab abdelhamid aboshama, lecturer of obstetrics and gynecology, Fayoum University
    ClinicalTrials.gov Identifier:
    NCT05118685
    Other Study ID Numbers:
    • R 180
    First Posted:
    Nov 12, 2021
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by rehab abdelhamid aboshama, lecturer of obstetrics and gynecology, Fayoum University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 3, 2021