Estrogen and Platelet Rich Plasma in Treatment of Atrophic Vaginitis

NCT ID: NCT05118685

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-13
• Study Completion Date: 2023-09-30

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.

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.

Conditions

Atrophic Vaginitis; Postmenopausal Atrophic Vaginitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Conjugated Estrogens vaginal cream 0,625mg

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

platelet rich plasma

Intervention Type: COMBINATION_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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Premarin cream

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University

OTHER

Sponsor Role: lead

Responsible Party

rehab abdelhamid aboshama

lecturer of obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

rehab A aboshama, lectuer

Role: PRINCIPAL_INVESTIGATOR

Fayoum University

Locations

Fayoum university faculity of medicine

Al Fayyum, Fayoum University Zone, Egypt

Site Status: RECRUITING

Fayoum university

Al Fayyum, , Egypt

Site Status: NOT_YET_RECRUITING

Countries

Egypt

Central Contacts

rehab A aboshama, lecturer

Role: CONTACT

ras07@fayoum.edu.eg

01156608221 ext. +2

Facility Contacts

rehab A aboshama, MD

Role: primary

ras07@fayoum.edu.eg

084 2114059 ext. +20

rehab A aboshama, lecturer

Role: primary

ras07@fayoum.edu.eg

01156608221

Other Identifiers

R 180

Identifier Type: -

Identifier Source: org_study_id