Genitourinary Syndrome of MenopauseNCT05782920
Management of Cancer Therapy Related Vulvovaginal Atrophy
A study testing Platelet rich plasma, non cross-linked hyaluronic acid and topical HA gel in people with Genitourinary Syndrome of Menopause, run by Alexandria University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to: 1. evaluate the efficacy of PRP injection and PRP injection mixed with non-cross-linked hyaluronic acid compared to the control group receiving standard therapy with topical non-cross-linked hyaluronic acid gel in the treatment of cancer therapy-induced or worsened vulvovaginal… Read more about this study
- Who is it for?
- Ages Up to 70 years, women only
- Conditions the study is for
- Genitourinary Syndrome of Menopause
- What is being tested?
- Platelet rich plasma, non cross-linked hyaluronic acid and topical HA gel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2020to 31 Mar 2021
- Phase
- Interventional
- 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 Up to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients have symptoms of VVA (vaginal dryness, burning, itching or dyspareunia)
- Patients with vaginal health index < 15.
- All patients have already finished cancer therapy or are on anti-estrogen treatment.
- Married sexually active
- Patients who are not receiving any VVA treatment for at least 30 days before starting therapy.
Who cannot join
- Active or recent history of vulvovaginal inflammation or infection
- History of vulvar or vaginal cancer.
- Suspicious lesion in the vulvovaginal area on the gynecological examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Platelet-rich Plasma (PRP) and Hyaluronic Acid (HA) in the Treatment of Cancer-therapy Related Vulvovaginal Atrophy and Its Impact on Sexual Satisfaction
The goal of this clinical trial is to:
- evaluate the efficacy of PRP injection and PRP injection mixed with non-cross-linked hyaluronic acid compared to the control group receiving standard therapy with topical non-cross-linked hyaluronic acid gel in the treatment of cancer therapy-induced or worsened vulvovaginal atrophy.
- To evaluate the impact of vulvovaginal atrophy treatment on the sexual satisfaction of both partners.
Read more
Patients will be divided randomly into 3 groups:
Group 1: 15 female patients will receive vaginal PRP injections. Group 2: 15 female patients will receive vaginal PRP injections combined with non-cross-linked hyaluronic acid.
Group 3: 15 female patients will receive topical non-cross-linked hyaluronic acid gel as a control group.
Read the detailed description
- The first group will receive two treatment of sub-mucosal PRP injection at the outer 3 cm of the vagina with one month interval in between. (17)
- The second group will receive two treatment of PRP injection mixed with non-cross linked hyaluronic acid at the outer 3 cm of the vagina with one month interval in between.
- 3-The third group will receive one applicator (5gm) three times per week of topical hyaluronic acid gel for vaginal application which will be prepared in the faculty of pharmacy for 2 months.
Clinical assessment Patients will be assessed for symptoms and signs of vulvovaginal atrophy (VVA) at baseline, one month, two months, and, three months after the end of treatment.
- Vulvovaginal atrophy (VVA) symptoms (dryness, dyspareunia) will be assessed on a subjective 10-point scale. Also, patient satisfaction with each type of treatment will be assessed with a questionnaire at the end of treatment and they will be asked if they wish to repeat the treatment to maintain effectiveness over time (yes or No).
- For assessment of VVA signs on physical examination, vaginal health index including assessment of pH, overall elasticity, epithelial mucosa, fluid secretion type, and consistency and moisture will be used as an objective method of evaluation of therapy.
- Assessment of sexual satisfaction of both male and female partners:
Sexual satisfaction was measured using the Arabic version of the Index of Sexual Satisfaction (ISS) and female sexual function index (FSFI) questionnaire.
- Conditions
- Genitourinary Syndrome of Menopause
- Being tested
- Platelet rich plasma, non cross-linked hyaluronic acid, topical HA gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet rich plasmaDevice
PRP can be considered a concentrate of autologous platelet-derived growth factors with known efficacy in tissue regeneration and wound healing.
non cross-linked hyaluronic acidDevice
HA filling is a known modality for rejuvenation
topical HA gelDevice
the standard treatment of vaginal atrophy and dryness
| Study group | Role | What they receive |
|---|---|---|
| PRP- treated Group A | Active comparator | 15 female patients will receive 2 vaginal PRP injections one month apart. Receives: Device: Platelet rich plasma |
| PRP-HA treated Group B | Active comparator | 15 female patients will receive 2 vaginal PRP-non-cross-linked HA injections spaced a month apart. Receives: Device: Platelet rich plasma; Device: non cross-linked hyaluronic acid |
| Control Group C | Active comparator | 15 female patients will receive topical non-cross-linked hyaluronic acid gel applied every three days for 2 months as a control group Receives: Device: topical HA gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vulvovaginal atrophy vaginal dryness severity scores
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Measured: before treatment
Vulvovaginal atrophy vaginal dryness severity scores
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Measured: after 1 month
Vulvovaginal atrophy vaginal dryness severity scores
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Measured: after 2 months
Vulvovaginal atrophy vaginal dryness severity scores
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Measured: 3 months follow up
Vulvovaginal atrophy dyspareunia severity scores
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Measured: before treatment
Vulvovaginal atrophy dyspareunia severity scores
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Measured: after 1 month
Vulvovaginal atrophy dyspareunia severity scores
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Measured: after 2 months
Vulvovaginal atrophy dyspareunia severity scores
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Measured: 3 months follow up
Vaginal health index total score
scores range from 5-25 with lower scores signifying greater atrophy
Measured: before treatment
Vaginal health index total score
scores range from 5-25 with lower scores signifying greater atrophy
Measured: after 1 month
Vaginal health index total score
scores range from 5-25 with lower scores signifying greater atrophy
Measured: after 2 months
Vaginal health index total score
scores range from 5-25 with lower scores signifying greater atrophy
Measured: 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start30 Jun 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Genitourinary Syndrome of MenopauseStudies of the same condition, open and under way.
- More trials run by Alexandria 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma samir, Alexandria University
- Investigators
- Salma Omar, MD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782920
- Sponsor's protocol ID
- 0201349
- Status last verified
- Mar 2023
- First submitted
- 19 Feb 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hersant B, SidAhmed-Mezi M, Belkacemi Y, Darmon F, Bastuji-Garin S, Werkoff G, Bosc R, Niddam J, Hermeziu O, La Padula S, Meningaud JP. Efficacy of injecting platelet concentrate combined with hyaluronic acid for the treatment of vulvovaginal atrophy in postmenopausal women with history of breast cancer: a phase 2 pilot study. Menopause. 2018 Oct;25(10):1124-1130. doi: 10.1097/GME.0000000000001122.
PubMed 29738415Omar SS, Elmulla KF, AboKhadr NA, Badawy AA, Ramadan EN, Hassouna AM, Heikal LA, Arafat WO. Comparable Efficacy of Submucosal Platelet-Rich Plasma and Combined Platelet-Rich Plasma Noncrosslinked Hyaluronic Acid Injections in Vulvovaginal Atrophy: A Cancer Survivorship Issue. J Womens Health (Larchmt). 2023 Sep;32(9):1006-1020. doi: 10.1089/jwh.2023.0144. Epub 2023 Jul 7.
PubMed 37417970
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Platelet-rich Plasma (PRP) and Hyaluronic Acid (HA) in the Treatment of Cancer-therapy Related Vulvovaginal Atrophy and Its Impact on Sexual Satisfaction
- ClinicalTrials.gov ID
- NCT05782920
- Acronym / sponsor ID
- 0201349
- Conditions
- Genitourinary Syndrome of Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 24 Mar 2023 (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.
The goal of this clinical trial is to:
- evaluate the efficacy of PRP injection and PRP injection mixed with non-cross-linked hyaluronic acid compared to the control group receiving standard therapy with topical non-cross-linked hyaluronic acid gel in the treatment of cancer therapy-induced or worsened vulvovaginal atrophy.
- To evaluate the impact of vulvovaginal atrophy treatment on the sexual satisfaction of both partners.
Patients will be divided randomly into 3 groups:
Group 1: 15 female patients will receive vaginal PRP injections. Group 2: 15 female patients will receive vaginal PRP injections combined with non-cross-linked hyaluronic acid.
Group 3: 15 female patients will receive topical non-cross-linked hyaluronic acid gel as a control group.
Detailed description
- The first group will receive two treatment of sub-mucosal PRP injection at the outer 3 cm of the vagina with one month interval in between. (17)
- The second group will receive two treatment of PRP injection mixed with non-cross linked hyaluronic acid at the outer 3 cm of the vagina with one month interval in between.
- 3-The third group will receive one applicator (5gm) three times per week of topical hyaluronic acid gel for vaginal application which will be prepared in the faculty of pharmacy for 2 months.
Clinical assessment Patients will be assessed for symptoms and signs of vulvovaginal atrophy (VVA) at baseline, one month, two months, and, three months after the end of treatment.
- Vulvovaginal atrophy (VVA) symptoms (dryness, dyspareunia) will be assessed on a subjective 10-point scale. Also, patient satisfaction with each type of treatment will be assessed with a questionnaire at the end of treatment and they will be asked if they wish to repeat the treatment to maintain effectiveness over time (yes or No).
- For assessment of VVA signs on physical examination, vaginal health index including assessment of pH, overall elasticity, epithelial mucosa, fluid secretion type, and consistency and moisture will be used as an objective method of evaluation of therapy.
- Assessment of sexual satisfaction of both male and female partners:
Sexual satisfaction was measured using the Arabic version of the Index of Sexual Satisfaction (ISS) and female sexual function index (FSFI) questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRP- treated Group A | Active comparator | Device: Platelet rich plasma15 female patients will receive 2 vaginal PRP injections one month apart. |
| PRP-HA treated Group B | Active comparator | Device: Platelet rich plasma, Device: non cross-linked hyaluronic acid15 female patients will receive 2 vaginal PRP-non-cross-linked HA injections spaced a month apart. |
| Control Group C | Active comparator | Device: topical HA gel15 female patients will receive topical non-cross-linked hyaluronic acid gel applied every three days for 2 months as a control group |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients have symptoms of VVA (vaginal dryness, burning, itching or dyspareunia)
Key exclusion criteria (3 listed)
- Active or recent history of vulvovaginal inflammation or infection
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 |
|---|---|---|
| Platelet rich plasmaPRP can be considered a concentrate of autologous platelet-derived growth factors with known efficacy in tissue regeneration and wound healing. | Device | PRP- treated Group A, PRP-HA treated Group B |
| non cross-linked hyaluronic acidHA filling is a known modality for rejuvenation | Device | PRP-HA treated Group B |
| topical HA gelthe standard treatment of vaginal atrophy and dryness | Device | Control Group C |
Primary outcome
Vulvovaginal atrophy vaginal dryness severity scores
Time frame: before treatment
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Vulvovaginal atrophy vaginal dryness severity scores
Time frame: after 1 month
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Vulvovaginal atrophy vaginal dryness severity scores
Time frame: after 2 months
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Vulvovaginal atrophy vaginal dryness severity scores
Time frame: 3 months follow up
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Vulvovaginal atrophy dyspareunia severity scores
Time frame: before treatment
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Vulvovaginal atrophy dyspareunia severity scores
Time frame: after 1 month
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Vulvovaginal atrophy dyspareunia severity scores
Time frame: after 2 months
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Vulvovaginal atrophy dyspareunia severity scores
Time frame: 3 months follow up
scores from 0-10 where 0: no symptoms, 1-3: mild symptoms, 4-6: moderate symptoms, 7-10: severe symptoms
Vaginal health index total score
Time frame: before treatment
scores range from 5-25 with lower scores signifying greater atrophy
Vaginal health index total score
Time frame: after 1 month
scores range from 5-25 with lower scores signifying greater atrophy
Vaginal health index total score
Time frame: after 2 months
scores range from 5-25 with lower scores signifying greater atrophy
Vaginal health index total score
Time frame: 3 months follow up
scores range from 5-25 with lower scores signifying greater atrophy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Background: PubMed 29738415Hersant B, SidAhmed-Mezi M, Belkacemi Y, Darmon F, Bastuji-Garin S, Werkoff G, Bosc R, Niddam J, Hermeziu O, La Padula S, Meningaud JP. Efficacy of injecting platelet concentrate combined with hyaluronic acid for the treatment of vulvovaginal atrophy in postmenopausal women with history of breast cancer: a phase 2 pilot study. Menopause. 2018 Oct;25(10):1124-1130. doi: 10.1097/GME.0000000000001122.
- Derived from this study: PubMed 37417970Omar SS, Elmulla KF, AboKhadr NA, Badawy AA, Ramadan EN, Hassouna AM, Heikal LA, Arafat WO. Comparable Efficacy of Submucosal Platelet-Rich Plasma and Combined Platelet-Rich Plasma Noncrosslinked Hyaluronic Acid Injections in Vulvovaginal Atrophy: A Cancer Survivorship Issue. J Womens Health (Larchmt). 2023 Sep;32(9):1006-1020. doi: 10.1089/jwh.2023.0144. Epub 2023 Jul 7.
- Individual participant dataSharing planned: No
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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.
Salma Omar, MD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet rich plasma, non cross-linked hyaluronic acid and topical HA gel in people with Genitourinary Syndrome of Menopause, run by Alexandria University at 1 site 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vulvovaginal atrophy vaginal dryness severity scores (time frame: before treatment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05782920, which also lists 2 linked publications.
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 24 Mar 2023.