Postmenopausal Vulvovaginal AtrophyNCT04657536
Evaluating the Efficacy of Temperature-controlled Radiofrequency (TRF) in the Treatment of Vulvovaginal Atrophy.
A study testing high frequency fulguration equipment and promestriene vaginal soft capsules in people with Postmenopausal Vulvovaginal Atrophy, run by Peking University People's Hospital at 1 site in China.
Trial summary
This project will be a prospective, multicenter, randomized cohort study. The investigators will select patients with vulvovaginal atrophy who have indications for treatment, and set up the experimental group (Peninsula temperature-controlled radiofrequency therapeutic apparatus group) and the control group… Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Postmenopausal Vulvovaginal Atrophy
- What is being tested?
- high frequency fulguration equipment and promestriene vaginal soft capsules
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2020to Dec 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 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Menopausal time at least one year.
- Genitourinary Syndrome of Menopause (GSM) related symptoms with moderate or severe intensity, such as dryness and dyspareunia, etc.
- Blood FSH≥30 IU/L (30mIU/mL)。
- Clinical symptoms and signs of vaginal atrophy score≥15.
- Breast ultrasound examination was grade 1-3 within 9 months before the study.
- Voluntary participation in clinical trials and signed informed consent.
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- Patients followed the treatment regimen and completed the study.
- Exclusion Criteria (one of the following criteria is excluded) :
- The patients who did not meet the inclusion criteria
- Received Estrogen replacement therapy (including local and systemic medication) within 3 months.
- Received any medicine (such as Baofukang suppository) to treat vulvovaginal atrophy within 3 months.
- Corticosteroids were used within 6 weeks. Long-term corticosteroids were used (intermittent nasal or skin application, eye drops and ears are allowed).
- Other experimental drugs were used within 1 month.
- Received vaginal laser therapy within 6 months.
- Patients with acute urinary tract infection;
- Patients with acute genital tract infection (genital herpes, trichomonad, fungal vaginitis; gonococcus, mycoplasma, chlamydia infection and bacterial vaginosis, etc.);
- Patients with pelvic organ prolapse greater than or equal to stage II;
- Patients with metal intrauterine device (IUD)；
- Patients with precancerous lesions or malignant tumors of vagina and cervix;
- Patients with serious heart, liver, brain, kidney, endocrine diseases, etc.
- Allergic to control drug and excipients.
- Other malignancies are known or suspected.
- With estrogen-dependent neoplasm.
- Confirm a history of depression or serious mental illness.
- There were consciousness barriers and communication barriers that could not cooperate with the experiment.
- Patients considered unsuitable for this clinical trial.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's University
Beijing, Beijing Municipality, 100044
Lijun Zhao, Dr., lilyzhaopku@163.com
About this study
Official title: Randomized Multicenter Clinical Trial for Evaluating the Efficacy of Temperature-controlled Radiofrequency Compared With Topical Estriol in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women
This project will be a prospective, multicenter, randomized cohort study. The investigators will select patients with vulvovaginal atrophy who have indications for treatment, and set up the experimental group (Peninsula temperature-controlled radiofrequency therapeutic apparatus group) and the control group (promestriene vaginal soft capsules group). Changes in vaginal exfoliated cell maturity index (MV), score of vaginal symptoms and signs, vaginal health index score (VHIS), female sexual function index score (FSFI), visual analogue score (VAS) before and after treatment, and adverse effects will be observed to analyze the safety and efficacy of temperature-controlled radiofrequency therapy for vulvovaginal atrophy in postmenopausal women.
- Conditions
- Postmenopausal Vulvovaginal Atrophy
- Being tested
- high frequency fulguration equipment, promestriene vaginal soft capsules
- Keywords
- vulvovaginal atrophy, temperature-controlled radiofrequency, postmenopausal woman, Genitourinary Syndrome of Menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high frequency fulguration equipmentDevice
Also called temperature controlled radiofrequency
All subjects will be carried out with 3 standard protocol TRF treatments to the vulvovaginal tissue using the high frequency fulguration equipment (Shenzhen Peninsula Medical co., Ltd) at 10-day to 15-day intervals. Radiofrequency energy was applied to the vaginal canal through a specialized probe combining monopolar and bipolar treatment modes. Monopolar treatment mode is for 15 minutes. Aim the three indication points A, B and C on the probe to the direction of 12 o'clock in turn. Each area should be treated for about 5 minutes. Rotate the probe clockwise when changing the area for treatment.Bipolar treatment mode is for 10 minutes. Firstly, indication point A is aimed to 12 o'clock for 5-minutes treatment and then the probe is rotated 90°clockwise for another 5-minutes treatment. The power setting will be 35-40w, and the target temperature setting will be 40 to 45℃, titrated to subject tolerance.
promestriene vaginal soft capsulesDrug
Also called Estriol
Promestriene vaginal soft capsules（Zhejiang Anbao Pharmaceutical Co. LTD）will be used 10mg once a day for continuous 20 days.
| Study group | Role | What they receive |
|---|---|---|
| TRF group | Experimental | the group who treated with temperature controlled radiofrequency Receives: Device: high frequency fulguration equipment |
| Estriol group | Active comparator | the group who treated with promestriene vaginal soft capsules Receives: Drug: promestriene vaginal soft capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change value of vaginal maturation index (VMI) compared with baseline
The Vaginal Maturation Index (VMI) is an assessment done to establish the oestrogen effect in the body. The vaginal cytology specimens were collected from the mid-vaginal-wall before treatment and fixed in ThinPrep solution. The VMI is a ratio obtained with three main cell types found in the vaginal walls: parabasal cells(P), Intermediate cells (I) and superficial cells(S). The findings will be presented in a 0/0/0 format. VMI = [1 × (% superficial cells)] + [0.6 × (% intermediate cells)] + [0.2 × (% parabasal cells)]. This index enabled us to objectively evaluate the differential count of each cell group expressed as a percentage. The greater the degree of vaginal atrophy, the greater the estrogen deficiency. When at most 30% of the deep cells were present in the vaginal smears, mild hypoestrogenism was diagnosed. A deep cell percentage between 30% and 49% indicated moderate hypoestrogenism and a more than 50% deep cell percentage indicated hypoestrogenism.
Measured: The two groups will be visited on day 0, 1 month and 3 months after the last treatment.
the changes of vaginal symptoms and signs scores compared with baseline
Symptoms (vaginal dryness, pruritus, burning, pain, shallow dyspareunia, deep dyspareunia) will be individually scored by women and signs (vaginal mucosa and petechia, vaginal elasticity, mucosal luster) will be individually scored by the investigators as 0 = absence, 1 = mild, 2 = moderate, and 3 = severe alteration. In addition, a composite score of symptoms and signs will calculated by the addition of the intensity scores of all individual symptoms and signs (range, 0-27: The higher the score is, the more severe the genitourinary atrophy is.). Symptoms and signs score (SSC) will be obtained at each visiting to assess the effect of treatment on all individual.
Measured: The two groups will be visited on day 0, day 20（the control group is day 21），1 month and 3 months after the last treatment.
Secondary outcomes (3)
The changes of vaginal health index score (VHI) compared with baseline
VHI scores accounted for the following five parameters: elasticity, fluid volume, pH, epithelial integrity, and moisture. Each parameter will be graded from 1 (worst condition) to 5 (best condition) with a maximum possible score of 25 points. Scores less than 15 are indicative of vaginal atrophy.
Measured: The two groups will be visited on day 0, day 20（the control group is day 21），1 month and 3 months after the last treatment.
The changes of female sexual function index score (FSFI) compared with baseline
Sexual function will be measured using the Female Sexual Function Index (FSFI). This questionnaire, which contains 19 items, was developed as a brief, but multidimensional, self-reporting instrument to assess the key dimensions of female sexual function. It was developed based on a group of normal female controls and age-matched women who met the DSM-IV-TR criteria for female sexual arousal disorder (FSAD). The FSFI addresses six domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain) and provides full-scale scores ranging from 2.0 (severe dysfunction) to 36.0 (absence of dysfunction). The validated FSFI version for the Chinese language will be used. A cutoff score of 26.55 will be used to differentiate the presence or absence of sexual dysfunction.
Measured: The two groups will be visited on day 0, 1 month and 3 months after the last treatment.
The changes of visual analogue score (VAS) compared with baseline
The Visual Analogue Scale (VAS) is a popular tool for the measurement of pain. The pain is represented by 11 Numbers from 0 to 10, 0 is painless and 10 is the most painful. The patient chooses one of these 11 Numbers to represent the pain level according to her own pain level.
Measured: The two groups will be visited on day 0, day 20（the control group is day 21），1 month and 3 months after the last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start8 Dec 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Vulvovaginal AtrophyStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Association of Plastics and Aesthetics
- Responsible party
- Principal investigator, Zhaolijun, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657536
- Sponsor's protocol ID
- Version 2.0；20200221
- Status last verified
- Mar 2021
- First submitted
- 8 Oct 2020
- Last updated
- 22 Mar 2021
- 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 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Clinical Trial for Evaluating the Efficacy of Temperature-controlled Radiofrequency Compared With Topical Estriol in the Treatment of Vulvovaginal Atrophy in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04657536
- Acronym / sponsor ID
- Version 2.0；20200221
- Conditions
- Postmenopausal Vulvovaginal Atrophy
- Keywords
- vulvovaginal atrophy, temperature-controlled radiofrequency, postmenopausal woman, Genitourinary Syndrome of Menopause
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Chinese Association of Plastics and Aesthetics
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Dec 2020 (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 project will be a prospective, multicenter, randomized cohort study. The investigators will select patients with vulvovaginal atrophy who have indications for treatment, and set up the experimental group (Peninsula temperature-controlled radiofrequency therapeutic apparatus group) and the control group (promestriene vaginal soft capsules group). Changes in vaginal exfoliated cell maturity index (MV), score of vaginal symptoms and signs, vaginal health index score (VHIS), female sexual function index score (FSFI), visual analogue score (VAS) before and after treatment, and adverse effects will be observed to analyze the safety and efficacy of temperature-controlled radiofrequency therapy for vulvovaginal atrophy in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRF group | Experimental | Device: high frequency fulguration equipmentthe group who treated with temperature controlled radiofrequency |
| Estriol group | Active comparator | Drug: promestriene vaginal soft capsulesthe group who treated with promestriene vaginal soft capsules |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Menopausal time at least one year.
- Genitourinary Syndrome of Menopause (GSM) related symptoms with moderate or severe intensity, such as dryness and dyspareunia, etc.
- Blood FSH≥30 IU/L (30mIU/mL)。
- Clinical symptoms and signs of vaginal atrophy score≥15.
- Breast ultrasound examination was grade 1-3 within 9 months before the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| high frequency fulguration equipmentAlso: temperature controlled radiofrequencyAll subjects will be carried out with 3 standard protocol TRF treatments to the vulvovaginal tissue using the high frequency fulguration equipment (Shenzhen Peninsula Medical co., Ltd) at 10-day to 15-day intervals. Radiofrequency energy was applied to the vaginal canal through a specialized probe combining monopolar and bipolar treatment modes. Monopolar treatment mode is for 15 minutes. Aim the three indication points A, B and C on the probe to the direction of 12 o'clock in turn. Each area should be treated for about 5 minutes. Rotate the probe clockwise when changing the area for treatment.Bipolar treatment mode is for 10 minutes. Firstly, indication point A is aimed to 12 o'clock for 5-minutes treatment and then the probe is rotated 90°clockwise for another 5-minutes treatment. The power setting will be 35-40w, and the target temperature setting will be 40 to 45℃, titrated to subject tolerance. | Device | TRF group |
| promestriene vaginal soft capsulesAlso: EstriolPromestriene vaginal soft capsules（Zhejiang Anbao Pharmaceutical Co. LTD）will be used 10mg once a day for continuous 20 days. | Drug | Estriol group |
Primary outcome
The change value of vaginal maturation index (VMI) compared with baseline
Time frame: The two groups will be visited on day 0, 1 month and 3 months after the last treatment.
The Vaginal Maturation Index (VMI) is an assessment done to establish the oestrogen effect in the body. The vaginal cytology specimens were collected from the mid-vaginal-wall before treatment and fixed in ThinPrep solution. The VMI is a ratio obtained with three main cell types found in the vaginal walls: parabasal cells(P), Intermediate cells (I) and superficial cells(S). The findings will be presented in a 0/0/0 format. VMI = [1 × (% superficial cells)] + [0.6 × (% intermediate cells)] + [0.2 × (% parabasal cells)]. This index enabled us to objectively evaluate the differential count of each cell group expressed as a percentage. The greater the degree of vaginal atrophy, the greater the estrogen deficiency. When at most 30% of the deep cells were present in the vaginal smears, mild hypoestrogenism was diagnosed. A deep cell percentage between 30% and 49% indicated moderate hypoestrogenism and a more than 50% deep cell percentage indicated hypoestrogenism.
the changes of vaginal symptoms and signs scores compared with baseline
Time frame: The two groups will be visited on day 0, day 20（the control group is day 21），1 month and 3 months after the last treatment.
Symptoms (vaginal dryness, pruritus, burning, pain, shallow dyspareunia, deep dyspareunia) will be individually scored by women and signs (vaginal mucosa and petechia, vaginal elasticity, mucosal luster) will be individually scored by the investigators as 0 = absence, 1 = mild, 2 = moderate, and 3 = severe alteration. In addition, a composite score of symptoms and signs will calculated by the addition of the intensity scores of all individual symptoms and signs (range, 0-27: The higher the score is, the more severe the genitourinary atrophy is.). Symptoms and signs score (SSC) will be obtained at each visiting to assess the effect of treatment on all individual.
3 secondary outcomes
The changes of vaginal health index score (VHI) compared with baseline
Time frame: The two groups will be visited on day 0, day 20（the control group is day 21），1 month and 3 months after the last treatment.
The changes of female sexual function index score (FSFI) compared with baseline
Time frame: The two groups will be visited on day 0, 1 month and 3 months after the last treatment.
The changes of visual analogue score (VAS) compared with baseline
Time frame: The two groups will be visited on day 0, day 20（the control group is day 21），1 month and 3 months after the last treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high frequency fulguration equipment and promestriene vaginal soft capsules in people with Postmenopausal Vulvovaginal Atrophy, run by Peking University People's Hospital at 1 site in China.
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 26 inclusion and 0 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 22 Mar 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lijun Zhao, Dr. (0086-10-88324384, lilyzhaopku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change value of vaginal maturation index (VMI) compared with baseline (time frame: The two groups will be visited on day 0, 1 month and 3 months after the last treatment.). The study lists 2 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 22 Mar 2021.