Vulvovaginal AtrophyNCT03557398
Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
A study testing Hydeal-D vaginal pessaries in people with Vulvovaginal Atrophy, run by Fidia Farmaceutici s.p.a. at 2 sites in Slovakia.
Trial summary
This study evaluates the efficacy and safety of hyaluronic acid derivative based vaginal pessaries for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Vulvovaginal Atrophy
- What is being tested?
- Hydeal-D vaginal pessaries
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSlovakia
- Study dates
- 29 Nov 2017to 29 May 2018
- 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 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum FSH levels >40 IU/L, or had been surgically postmenopausal for more than 6 months)
- Women between 45 and 75 years of age.
- Vaginal pH ≥5
- Vulvovaginal atrophy with VHI < 15
- At least one of the following symptoms of vulvar and vaginal atrophy, assessed as moderate to severe: vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity
- Women with active sex lives
- Patients who give written informed consent to participate in the trial
Who cannot join
- Enrollment in other clinical trials within the previous 1 month.
- Patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week
- Patients in previous treatment with either oral or topical hormonal products within 1 month.
- Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV); or history of vulgovaginal contact allergy.
- Patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors.
- Positive history of hypersensitivity hyaluronic acid or to any component of the medical device.
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- Women with no active sex lives
- Women who do not give informed consent;
- Any condition in the investigator's opinion not suitable for the inclusion were condition for not eligibility of the patient
Trial locations and contacts
2 sites in 1 country.
Slovakia2 sites
Gynkomed s.r.o.
Bratislava, 83107
ULMUS, s r.o.
Hlohovec, 920 01
About this study
Official title: Prospective Clinical Study to Assess the Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
This study evaluates the efficacy and safety of hyaluronic acid derivative based vaginal pessaries for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.
- Conditions
- Vulvovaginal Atrophy
- Being tested
- Hydeal-D vaginal pessaries
- Keywords
- Hyaluronic acid, Post-menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydeal-D vaginal pessariesDevice
Also called Hyalogyn vaginal pessaries
One vaginal application of Hydeal-D vaginal pessaries every 3 days to a total of 12 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hydeal-D vaginal pessaries | Experimental | Vaginal application of Hydeal-D vaginal pessaries Receives: Device: Hydeal-D vaginal pessaries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the average score of Vaginal Health Index (VHI)
Change of Vaginal Health Index (VHI) calculated on the basis of vaginal elasticity, vaginal fluid volume, vaginal pH, vaginal mucosa epithelial integrity, and vaginal moisture on a scale ranging from 1 (poorest) to 5 (best). VHI assigned score is the sum of subscores and ranges from 5 to 25. A lower score corresponds to a greater atrophy.
Measured: From baseline to 12 weeks of treatment
Secondary outcomes (9)
Change of the average score of Vaginal Health Index (VHI)
Change of Vaginal Health Index (VHI) calculated on the basis of vaginal elasticity, vaginal fluid volume, vaginal pH, vaginal mucosa epithelial integrity, and vaginal moisture on a scale ranging from 1 (poorest) to 5 (best). VHI assigned score is the sum of subscores and ranges from 5 to 25. A lower score corresponds to a greater atrophy.
Measured: From baseline to 4 weeks of treatment
Change of vaginal pH
The pH values are grouped on a four-point scale and scored respectively: pH lower than 5 = 0; pH between 5 and 5.49 = 1; pH between 5.5 and 6.49 = 2; pH higher than 6.49 =3.
Measured: From baseline to 4 and 12 weeks of treatment
Change of patient's perception of vulvovaginal symptoms
Symptoms associated with vulvovaginal atrophy (dryness, irritation/itching, soreness, dysuria, dyspareunia) are reported on a four-point scale (0=absent, 1=mild, 2=moderate, 3=severe).
Measured: From baseline to 4 and 12 weeks of treatment
Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI)
Female Sexual Function Index (FSFI) questionnaire consists of six domains - desire (two items), arousal (four items), lubrication (four items), orgasm (three items), satisfaction (three items), and pain (three items) - answered on a five-point Likert scale (0, no sexual activity; 1, never/very low; 5, always/very high). A score is calculated for each of the six domains, and the total score is obtained by summing all of the items. Total score ranges from 2 to 36. A lower score corresponds to a greater sexual dysfunction.
Measured: From baseline to 4 and 12 weeks of treatment
Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R)
Female Sexual Distress Scale-Revised (FSDS-R) questionnaire consists of 13 items scored on a five-point scale (0, never; 1, rarely; 2, occasionally; 2, frequently; 4, always). The total score is obtained by summing all of the items. Total score ranges from 0 to 52. A higher score corresponds to a greater sexual dysfunction.
Measured: From baseline to 4 and 12 weeks of treatment
Amelioration of the vaginal maturation (VM) index
Vaginal maturation (VM) index is calculated quantifying the percentages of parabasal, intermediate, and superficial cells. The following formula is used: VMI = [1(% superficial cells)] + [0.6(% intermediate cells)] + [0.2(% parabasal cells)]. The index ranges from 0% to 100%.The higher the maturation index, the higher the number of mature cells (0%-49%, low stimulation of the vaginal epithelium; 50%-64%, moderate stimulation of the vaginal epithelium; 65%-100%, high stimulation of the vaginal epithelium).
Measured: From baseline to 12 weeks of treatment
Patient's global assessment of overall satisfaction
Patient's global assessment (PTGA) is evaluated as the patient's overall satisfaction of the treatment scored on a four grade scale, ranging from 0 to 3 (0= dissatisfied or very dissatisfied, 1= moderately satisfied or satisfied, 2= very satisfied and 3= greatly satisfied). A higher score corresponds to a greater satisfaction.
Measured: 4 and 12 weeks of treatment
Local tolerability at the application site
Local tolerability of the product at the application site is evaluated by both the clinician and the patient independently, through a 5-point scale, ranging from 0 to 5 (1 = excellent (no reaction), 2 = good (small reaction that spontaneously resolves), 3 = moderate (reaction tolerated with difficulty by the subject), 4 = poor (reaction needing interruption of treatment), 5 = bad (serious reaction)). A higher score corresponds to a better tolerability.
Measured: 4 and 12 weeks of treatment
Safety of the treatment: Collection of adverse events
Collection of adverse events emerged as consequence of the product application and any other adverse event occurred during the study
Measured: 4 and 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start29 Nov 2017
- Primary completion29 May 2018
- Study completion29 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal AtrophyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557398
- Sponsor's protocol ID
- QQ53-17-01
- Status last verified
- Jun 2018
- First submitted
- 18 May 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study to Assess the Efficacy and Safety of HYDEAL-D Vaginal Pessaries Application on the Treatment of Vaginal Atrophy in Post-menopause Women
- ClinicalTrials.gov ID
- NCT03557398
- Acronym / sponsor ID
- QQ53-17-01
- Conditions
- Vulvovaginal Atrophy
- Keywords
- Hyaluronic acid, Post-menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 29 May 2018 (actual)
- First posted
- 15 Jun 2018 (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 evaluates the efficacy and safety of hyaluronic acid derivative based vaginal pessaries for the treatment of symptoms of vulvo-vaginal atrophy in post-menopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydeal-D vaginal pessaries | Experimental | Device: Hydeal-D vaginal pessariesVaginal application of Hydeal-D vaginal pessaries |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Postmenopausal woman (≥12 months since last spontaneous menstrual period, or having 6 months of spontaneous amenorrhea with serum FSH levels >40 IU/L, or had been surgically postmenopausal for more than 6 months)
- Women between 45 and 75 years of age.
- Vaginal pH ≥5
- Vulvovaginal atrophy with VHI < 15
- At least one of the following symptoms of vulvar and vaginal atrophy, assessed as moderate to severe: vaginal dryness, vaginal and/or vulvar irritation/ itching, dysuria, vaginal pain associated with sexual activity
Key exclusion criteria (9 listed)
- Enrollment in other clinical trials within the previous 1 month.
- Patients in previous treatment with any kind of no-hormonal products for local treatment of vaginal atrophy within 1 week
- Patients in previous treatment with either oral or topical hormonal products within 1 month.
- Patients that present clinical signs of vaginal infections such as trichomonas, candida, and bacterial vaginosis (BV); or history of vulgovaginal contact allergy.
- Patients with acute hepatopathy, embolic disorders, severe primary disease of the kidney and hematopoietic system, and history of malignant tumors.
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 |
|---|---|---|
| Hydeal-D vaginal pessariesAlso: Hyalogyn vaginal pessariesOne vaginal application of Hydeal-D vaginal pessaries every 3 days to a total of 12 consecutive weeks. | Device | Hydeal-D vaginal pessaries |
Primary outcome
Change of the average score of Vaginal Health Index (VHI)
Time frame: From baseline to 12 weeks of treatment
Change of Vaginal Health Index (VHI) calculated on the basis of vaginal elasticity, vaginal fluid volume, vaginal pH, vaginal mucosa epithelial integrity, and vaginal moisture on a scale ranging from 1 (poorest) to 5 (best). VHI assigned score is the sum of subscores and ranges from 5 to 25. A lower score corresponds to a greater atrophy.
9 secondary outcomes
Change of the average score of Vaginal Health Index (VHI)
Time frame: From baseline to 4 weeks of treatment
Change of vaginal pH
Time frame: From baseline to 4 and 12 weeks of treatment
Change of patient's perception of vulvovaginal symptoms
Time frame: From baseline to 4 and 12 weeks of treatment
Improvement of sexual function through questionnaire Female Sexual Function Index (FSFI)
Time frame: From baseline to 4 and 12 weeks of treatment
Improvement of sexual function through questionnaire Female Sexual Distress Scale-Revised (FSDS-R)
Time frame: From baseline to 4 and 12 weeks of treatment
Amelioration of the vaginal maturation (VM) index
Time frame: From baseline to 12 weeks of treatment
Patient's global assessment of overall satisfaction
Time frame: 4 and 12 weeks of treatment
Local tolerability at the application site
Time frame: 4 and 12 weeks of treatment
Safety of the treatment: Collection of adverse events
Time frame: 4 and 12 weeks of treatment
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 15 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydeal-D vaginal pessaries in people with Vulvovaginal Atrophy, run by Fidia Farmaceutici s.p.a. at 2 sites in Slovakia.
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 7 inclusion and 9 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 15 Jun 2018. 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 Slovakia. 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?
Change of the average score of Vaginal Health Index (VHI) (time frame: From baseline to 12 weeks of treatment). 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 15 Jun 2018.