Atrophic VaginitisPhase 1NCT05118685
Estrogen and Platelet Rich Plasma in Treatment of Atrophic Vaginitis
A Phase 1 study testing Conjugated Estrogens vaginal cream 0,625mg and platelet rich plasma in people with Atrophic Vaginitis and Postmenopausal Atrophic Vaginitis, run by Fayoum University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Atrophic Vaginitis, Postmenopausal Atrophic Vaginitis
- What is being tested?
- Conjugated Estrogens vaginal cream 0,625mg and platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 13 Nov 2021to Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Fayoum university faculity of medicine
Al Fayyum, Fayoum University Zone, 63514
rehab A aboshama, MD, 084 2114059 ext. +20, ras07@fayoum.edu.eg
- Not yet recruiting
Fayoum university
Al Fayyum, 63514
rehab A aboshama, lecturer, 01156608221, ras07@fayoum.edu.eg
About this study
Official title: A Comparative Study of Vaginal Oestrogen Cream and Platelet Rich Plasma in Treatment of Atrophic Vaginitis in Fayoum University Hospital
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.
Read the 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.
- Being tested
- Conjugated Estrogens vaginal cream 0,625mg, platelet rich plasma
- Keywords
- atrophic vaginitis, Platelet rich plasma, postmenopausal symptoms
- Medical subject headings
- Atrophic Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjugated Estrogens vaginal cream 0,625mgDrug
Also called Premarin cream
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 12 week
Secondary outcomes (2)
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
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start13 Nov 2021
- Primary completionAug 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic VaginitisStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab abdelhamid aboshama, Fayoum University
- Investigators
- rehab A aboshama, lectuer, Principal investigator, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118685
- Sponsor's protocol ID
- R 180
- Status last verified
- Apr 2023
- First submitted
- 29 Sep 2021
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Vaginal Oestrogen Cream and Platelet Rich Plasma in Treatment of Atrophic Vaginitis in Fayoum University Hospital
- ClinicalTrials.gov ID
- NCT05118685
- Acronym / sponsor ID
- R 180
- Keywords
- atrophic vaginitis, Platelet rich plasma, postmenopausal symptoms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 13 Nov 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| the first group estrogen group | Active comparator | Drug: Conjugated Estrogens vaginal cream 0,625mgthey 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. |
| the second group PRP group | Experimental | Combination Product: platelet rich plasmathey 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conjugated Estrogens vaginal cream 0,625mgAlso: Premarin creamthe 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. | Drug | the first group estrogen group |
| platelet rich plasmaFirst, 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. | Combination product | the second group PRP group |
Primary outcome
improvement in Vaginal Health Index (VHI).
Time frame: 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
improvement in Vulvovaginal atrophy (VVA) symptoms using the Visual analog scale (VAS).
Time frame: 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.
Assessment of quality of sexual function using the validated Portuguese version of the Female Sexual Function Index (FSFI)
Time frame: 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.
2 secondary outcomes
Assessment of tolerability and safety of Platelet rich plasma (PRP).
Time frame: 12 weeks
Assessment of tolerability and safety of estrogen vaginal cream
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No
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Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV
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VALOR: Vaginal Atrophy & Long-term Observation of Recovery
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Difference in Serum Estrogen Level Based on Methods of Vaginal Estrogen Application (fingertip Vs Applicator Use) in Post-menopausal Women
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
rehab A aboshama, lectuer principal investigator
Fayoum University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Conjugated Estrogens vaginal cream 0,625mg and platelet rich plasma in people with Atrophic Vaginitis and Postmenopausal Atrophic Vaginitis, run by Fayoum University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rehab A aboshama, lecturer (01156608221 ext. +2, ras07@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in Vaginal Health Index (VHI). (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.