NCT05118685

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 12, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

November 13, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

1.7 years

First QC Date

September 29, 2021

Last Update Submit

April 27, 2023

Conditions

Atrophic VaginitisPostmenopausal Atrophic Vaginitis

Keywords

atrophic vaginitisPlatelet rich plasmapostmenopausal symptoms

Outcome Measures

Primary Outcomes (3)

  • improvement in Vaginal Health Index (VHI).

    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

    12 weeks

  • improvement in Vulvovaginal atrophy (VVA) symptoms using the Visual analog scale (VAS).

    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.

    12 week

  • Assessment of quality of sexual function using the validated Portuguese version of the Female Sexual Function Index (FSFI)

    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.

    12 week

Secondary Outcomes (2)

  • Assessment of tolerability and safety of Platelet rich plasma (PRP).

    12 weeks

  • Assessment of tolerability and safety of estrogen vaginal cream

    12 weeks

Study Arms (2)

the first group estrogen group

ACTIVE COMPARATOR

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 second group PRP group

EXPERIMENTAL

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

Interventions

Conjugated Estrogens vaginal cream 0,625mgDRUG

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.

Also known as: Premarin cream
the first group estrogen group
platelet rich plasmaCOMBINATION_PRODUCT

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.

the second group PRP group

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostmenopausal atrophic vaginitis
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fayoum university faculity of medicine

Al Fayyum, Fayoum University Zone, 63514, Egypt

RECRUITING

Fayoum university

Al Fayyum, 63514, Egypt

NOT YET RECRUITING

MeSH Terms

Conditions

Atrophic Vaginitis

Condition Hierarchy (Ancestors)

VaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • rehab A aboshama, lectuer

    Fayoum University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

rehab A aboshama, lecturer

CONTACT

01156608221ras07@fayoum.edu.eg

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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 pt
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

September 29, 2021

First Posted

November 12, 2021

Study Start

November 13, 2021

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

May 1, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)