MenopauseNCT05483634
Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
An observational study of Menopause and Platelet-rich Plasma, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
The definition of Genitourinary Syndrome of Menopause (GSM) is the decline of estrogens during menopause results in symptoms and clinical signs from both systems. Estrogen and other hormones production decrease after menopause because the ovaries lose their effectiveness, leading to mucosal atrophy, reduced vaginal… Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Menopause, Platelet-rich Plasma, Estrogen Replacement Therapy
- What is being tested?
- Vaginal estrogen supplement and Platelet-rich plasma injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Menopause for one year Age above 45 with symptoms of GSM
Who may be able to join
- Women with menopause
- Patients with symptoms of genitourinary syndrome of menopause
Who cannot join
- Genitourinary bleeding or infection without definitive diagnosis
- Coagulopathy
- Allergy to medication or therapy related with the treatment
- Chronic disease that might influence outcome
- Using medication that might influence outcome in 30 days
- Using hormone or steroid within 8 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
MacKay Memorial Hospital
Taipei, 104
Hui-Hsuan Lau, MD, +88625433535, huihsuan1220@gmail.com
About this study
Official title: Compare the Effectiveness and Side Effects of Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
The definition of Genitourinary Syndrome of Menopause (GSM) is the decline of estrogens during menopause results in symptoms and clinical signs from both systems. Estrogen and other hormones production decrease after menopause because the ovaries lose their effectiveness, leading to mucosal atrophy, reduced vaginal moisture, dysuria, urgency, recurrent infection, burning, pruritus and dyspareunia.
The treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet rich plasma, etc. Observational cohort study will be used for study design, and questionnaire, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used for evaluation of the effectiveness and side effects.
- Being tested
- Vaginal estrogen supplement, Platelet-rich plasma injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal estrogen supplementDrug
Daily vaginal estrogen supplement, then twice per week. Continue for three months.
Platelet-rich plasma injectionProcedure or surgery
Monthly platelet-rich plasma injection for three months
| Study group | Role | What they receive |
|---|---|---|
| Genital urinary symptoms of menopause | Menopause for one year, or age above 45 with symptoms of GSM Receives: Drug: Vaginal estrogen supplement; Procedure: Platelet-rich plasma injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS)
Changes in GSM symptoms include vaginal dryness, dyspareunia, itching, burning, dysuria
Measured: 2022/8/10-2024/2/28
Vaginal health index score (VHIS)
One of the most commonly used scores for the evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration
Measured: 2022/8/10-2024/2/28
Female Sexual Function Index (FSFI)
A brief multidimensional scale for assessing sexual function in women.
Measured: 2022/8/10-2024/2/28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start1 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Hsuan Lau, MD, Mackay Memorial Hospital
- Investigators
- Hui-Hsuan Lau, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483634
- Sponsor's protocol ID
- 19MMHIS340e
- Status last verified
- May 2025
- First submitted
- 31 Jul 2022
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gandhi J, Chen A, Dagur G, Suh Y, Smith N, Cali B, Khan SA. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. Am J Obstet Gynecol. 2016 Dec;215(6):704-711. doi: 10.1016/j.ajog.2016.07.045. Epub 2016 Jul 26.
PubMed 27472999Pitsouni E, Grigoriadis T, Falagas ME, Salvatore S, Athanasiou S. Laser therapy for the genitourinary syndrome of menopause. A systematic review and meta-analysis. Maturitas. 2017 Sep;103:78-88. doi: 10.1016/j.maturitas.2017.06.029. Epub 2017 Jun 27.
PubMed 28778337Pitsouni E, Grigoriadis T, Douskos A, Kyriakidou M, Falagas ME, Athanasiou S. Efficacy of vaginal therapies alternative to vaginal estrogens on sexual function and orgasm of menopausal women: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:45-56. doi: 10.1016/j.ejogrb.2018.08.008. Epub 2018 Aug 6.
PubMed 30103082Najjarzadeh M, Mohammad Alizadeh Charandabi S, Mohammadi M, Mirghafourvand M. Comparison of the effect of hyaluronic acid and estrogen on atrophic vaginitis in menopausal women: A systematic review. Post Reprod Health. 2019 Jun;25(2):100-108. doi: 10.1177/2053369119830818. Epub 2019 Feb 24. No abstract available.
PubMed 30798700Saleh DM, Abdelghani R. Clinical evaluation of autologous platelet rich plasma injection in postmenopausal vulvovaginal atrophy: A pilot study. J Cosmet Dermatol. 2022 Oct;21(10):4269-4275. doi: 10.1111/jocd.14873. Epub 2022 Mar 7.
PubMed 35194935
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Effectiveness and Side Effects of Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause
- ClinicalTrials.gov ID
- NCT05483634
- Acronym / sponsor ID
- 19MMHIS340e
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Aug 2022 (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 definition of Genitourinary Syndrome of Menopause (GSM) is the decline of estrogens during menopause results in symptoms and clinical signs from both systems. Estrogen and other hormones production decrease after menopause because the ovaries lose their effectiveness, leading to mucosal atrophy, reduced vaginal moisture, dysuria, urgency, recurrent infection, burning, pruritus and dyspareunia.
The treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet rich plasma, etc. Observational cohort study will be used for study design, and questionnaire, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used for evaluation of the effectiveness and side effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genital urinary symptoms of menopause | – | Drug: Vaginal estrogen supplement, Procedure: Platelet-rich plasma injectionMenopause for one year, or age above 45 with symptoms of GSM |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Menopause for one year Age above 45 with symptoms of GSM
Key inclusion criteria (2 listed)
- Women with menopause
- Patients with symptoms of genitourinary syndrome of menopause
Key exclusion criteria (6 listed)
- Genitourinary bleeding or infection without definitive diagnosis
- Coagulopathy
- Allergy to medication or therapy related with the treatment
- Chronic disease that might influence outcome
- Using medication that might influence outcome in 30 days
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 |
|---|---|---|
| Vaginal estrogen supplementDaily vaginal estrogen supplement, then twice per week. Continue for three months. | Drug | Genital urinary symptoms of menopause |
| Platelet-rich plasma injectionMonthly platelet-rich plasma injection for three months | Procedure or surgery | Genital urinary symptoms of menopause |
Primary outcome
Visual analogue scale (VAS)
Time frame: 2022/8/10-2024/2/28
Changes in GSM symptoms include vaginal dryness, dyspareunia, itching, burning, dysuria
Vaginal health index score (VHIS)
Time frame: 2022/8/10-2024/2/28
One of the most commonly used scores for the evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration
Female Sexual Function Index (FSFI)
Time frame: 2022/8/10-2024/2/28
A brief multidimensional scale for assessing sexual function in women.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Background: PubMed 27472999Gandhi J, Chen A, Dagur G, Suh Y, Smith N, Cali B, Khan SA. Genitourinary syndrome of menopause: an overview of clinical manifestations, pathophysiology, etiology, evaluation, and management. Am J Obstet Gynecol. 2016 Dec;215(6):704-711. doi: 10.1016/j.ajog.2016.07.045. Epub 2016 Jul 26.
- Background: PubMed 28778337Pitsouni E, Grigoriadis T, Falagas ME, Salvatore S, Athanasiou S. Laser therapy for the genitourinary syndrome of menopause. A systematic review and meta-analysis. Maturitas. 2017 Sep;103:78-88. doi: 10.1016/j.maturitas.2017.06.029. Epub 2017 Jun 27.
- Background: PubMed 30103082Pitsouni E, Grigoriadis T, Douskos A, Kyriakidou M, Falagas ME, Athanasiou S. Efficacy of vaginal therapies alternative to vaginal estrogens on sexual function and orgasm of menopausal women: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:45-56. doi: 10.1016/j.ejogrb.2018.08.008. Epub 2018 Aug 6.
- Background: PubMed 30798700Najjarzadeh M, Mohammad Alizadeh Charandabi S, Mohammadi M, Mirghafourvand M. Comparison of the effect of hyaluronic acid and estrogen on atrophic vaginitis in menopausal women: A systematic review. Post Reprod Health. 2019 Jun;25(2):100-108. doi: 10.1177/2053369119830818. Epub 2019 Feb 24. No abstract available.
- Background: PubMed 35194935Saleh DM, Abdelghani R. Clinical evaluation of autologous platelet rich plasma injection in postmenopausal vulvovaginal atrophy: A pilot study. J Cosmet Dermatol. 2022 Oct;21(10):4269-4275. doi: 10.1111/jocd.14873. Epub 2022 Mar 7.
- Individual participant dataSharing planned: Undecided
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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.
Hui-Hsuan Lau principal investigator
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Platelet-rich Plasma, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 9 May 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui-Hsuan Lau (+886-25433535, huihsuan1220@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) (time frame: 2022/8/10-2024/2/28). 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?
On the ClinicalTrials.gov record for NCT05483634, which also lists 5 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 9 May 2025.