Clinical trial NCT05118685: Estrogen and Platelet Rich Plasma in Treatment of Atrophic Vaginitis
Official title: A Comparative Study of Vaginal Oestrogen Cream and Platelet Rich Plasma in Treatment of Atrophic Vaginitis in Fayoum University Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Atrophic Vaginitis
Postmenopausal Atrophic Vaginitis
Keywords: atrophic vaginitis
Platelet rich plasma
postmenopausal symptoms
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 pt
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: improvement in Vaginal Health Index (VHI).
timeFrame: 12 weeks
measure: improvement in Vulvovaginal atrophy (VVA) symptoms using the Visual analog scale (VAS).
timeFrame: 12 week
measure: Assessment of quality of sexual function using the validated Portuguese version of the Female Sexual Function Index (FSFI)
timeFrame: 12 week
Secondary outcomes:
measure: Assessment of tolerability and safety of Platelet rich plasma (PRP).
timeFrame: 12 weeks
measure: Assessment of tolerability and safety of estrogen vaginal cream
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum university faculity of medicine
state: Fayoum University Zone
city: Fayoum
country: Egypt
facility: Fayoum university
Study officials:
affiliation: Fayoum University
name: rehab A aboshama, lectuer
role: PRINCIPAL_INVESTIGATOR
References: