A Phase 1 interventional study of Conjugated Estrogens vaginal cream 0,625mg and platelet rich plasma in Atrophic Vaginitis and Postmenopausal Atrophic Vaginitis, sponsored by Fayoum University. Status unknown at 2 sites in Egypt. Open to female participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-05-01.
Sponsored by Fayoum University · Phase 1, Interventional, and Treatment
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.
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.
45 studies on the registry are indexed under Atrophic Vaginitis; 7 are open to participants now.
This study's planned enrollment of 100 is above the median of 69 across 40 interventional studies indexed under Atrophic Vaginitis.
Browse Atrophic Vaginitis studies →Fayoum University is the lead sponsor of 148 studies on the registry; 44 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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
Time frame: 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.
Time frame: 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.
Time frame: 12 week
Assessment of tolerability and safety of Platelet rich plasma (PRP).
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
Time frame: 12 weeks
Assessment of tolerability and safety of estrogen vaginal cream
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
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2021 (actual). Primary completion is estimated for Aug 2023, 21 months after the start.
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This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Platelet rich plasma