Vaginal DiseaseNCT04245293
Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®
A study testing Ainara and HyaloGin in people with Vaginal Disease, run by Italfarmaco at 1 site in Romania.
Trial summary
This study evaluates treatment with the medical device Ainara® compared to a HA-based gel (Hyalogin) on the improvement of vaginal dryness Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Vaginal Disease
- What is being tested?
- Ainara and HyaloGin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRomania
- Study dates
- 11 Apr 2019to 22 Nov 2019
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Non-pregnant and in menopausal transition period (late peri-menopause) women following the STRAW criteria and with a break in menstrual periods of at least 60 days, aged ≥ 45 to ≤ 55 years.
- Diagnosis of vaginal dryness by subjective dryness, any objective sign of VVA, pH>5 as reported in the AGATA study and VHI < 15.
- Body mass index of ≥ 18.5 to ≤ 36 kg/m2.
- Females of child bearing potential who agree to use only lubricated condoms or spiral as contraceptives methods, during the full duration of the study.
- Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
- Capable of and freely willing to provide written informed consent prior to participating in the study.
Who cannot join
- Women in post-menopausal (total cessation of menses for ≥ 1 year from the date of the screening visit).
- Malignancy (also leukemic infiltrates) within 5 years prior to day 0 (except for treated basal cell/squamous cell carcinoma of the skin).
- Genital bleeding.
- Estrogen vaginal treatment during the study period (permitted only if terminated at least 6 months before study).
- Systemic estrogen therapy (permitted only if terminated at least 6 months before study).
- Subjects with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
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- Clinical evidence of acute infection currently requiring treatment (syphilis, herpes simplex, human papilloma virus, gonorrhoea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (i.e. tuberculosis).
- Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except for intermittent anxiety).
- Known allergy to tested IMDs or its excipients.
- Drug or alcohol abuse within 12 months of Day 0.
- Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
- Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open, Comparative Study To Evaluate The Performance And Safety Of The Medical Device AINARA® Vaginal Gel Versus A Hyaluronic Acid-Based Gel In Late Menopausal Transition Women Affected By Vaginal Dryness
This study evaluates treatment with the medical device Ainara® compared to a HA-based gel (Hyalogin) on the improvement of vaginal dryness
Read the detailed description
This is an open, comparative, multicenter study that evaluates the performance and safety of the medical device Ainara®.
In this study we use polycarbophilic vaginal moisturizing gel (Ainara®) compared with a HA-based gel (Hyalogin) for symptomatic treatment of vaginal dryness and we will monitor its impact on vaginal dryness symptoms evaluated by Vaginal Health Index and Vaginal Analogue Scale.
- Conditions
- Vaginal Disease
- Being tested
- Ainara, HyaloGin
- Medical subject headings
- Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AinaraDevice
Each administration kit (subject kit) for patients of Ainara® will contain a box with 1 tube with 30 g gel, 1 cannula and 1 plunger. The gel quantity is enough for one subject over the course of the study (1 g at each administration).
HyaloGinDevice
Active Comparator: HyaloGin Each administration kit (subject kit) for patients allocated to HyaloGyn® group will contain a box with: 1 tube with 30g gel and 10 single-use applicators consisting of a piston and one opaque plastic plunger.
The gel quantity is enough for one subject (3g application every three days over the course of the study).
| Study group | Role | What they receive |
|---|---|---|
| Ainara | Experimental | Experimental: Ainara Each administration kit (subject kit) for patients of Ainara® will contain a box with 1 tube with 30 g gel, 1 cannula and 1 plunger. The gel quantity is enough for one subject over the course of the study (1 g at each administration). Receives: Device: Ainara |
| HyaloGin | Active comparator | Active Comparator: HyaloGin Each administration kit (subject kit) for patients allocated to HyaloGyn® group will contain a box with: 1 tube with 30g gel and 10 single-use applicators consisting of a piston and one opaque plastic plunger.
The gel quantity is enough for one subject (3g application every three days over the course of the study). Receives: Device: HyaloGin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Vaginal Health Index (VHI)
The changing from baseline to day 30 (final visit) for VHI mean value in each group separately and the changing in the Ainara® group in comparison with that occurred in HyaloGyn® group; The minim score is 5 and the maxim is is 25
Measured: 30 days
Visual Analogue Scale (VAS)
The changing from baseline to day 3, 7, 21, 30 (final visit) for VAS mean value in each group separately and in the Ainara® group in comparison with that occurred in HyaloGyn® group. The minim score is 0 and the maxim score is 5, where 0 represents no symptoms and 3 represents severe symptoms
Measured: 30 days
Secondary outcomes (10)
subjective symptoms
Subjective symptoms dryness, itching, burning, dyspareunia, and dysuria reported on patient diary and scored as reported in the AGATA study as follows:
0 = absence, 1 = slight, 2 = moderate, and 3 = severe intensity. The change in these variables will be evaluated from baseline to day 3, 7, 21, 30 (final visit).
Measured: 30 days
objective signs in the vaginal mucosa
Objective signs in the vaginal mucosa: dryness, thinning rugae, pallor, fragility, and petechiae scored as reported in the AGATA study as follows:
0 = absence, 1 = slight, 2 = moderate, and 3 = severe alteration. For these variables will be evaluated the changing from baseline to day 3, 7, 21, 30 (final visit) with comparison intra and inter groups.
Measured: 30 days
Vaginal pH
It will be measured by the Investigators with a test strip delivered by Sponsor. The baseline values can be from 5.0 (this was the minimum value need for vaginal atrophy diagnosis in AGATA study) to 9.0. The Investigator will insert the pH strip into the upper wall of the vagina and will consider the reading made while the strip is still damp. For this outcome will be analysed the changing of mean values from baseline to 30 day (final visit) with comparison intra and inter groups.
Measured: 30 days
Vaginal Trophism Maturation Value (MV)
Vaginal Trophism Maturation Value (MV): this outcome will be obtained from the cellular count of the vaginal smears at baseline and at the 30 days visit. The samples will be fixed, stored, and sent in the local laboratory in Timisoara, Romania (address details in TMF) for staining (Papanicolaou technique) and subsequent analysis. Samples will be evaluated by one independent cytopathologist blinded to the treatment. The MV will be calculated according to the following: MV = [1x (% superficial cells)] + [0.6x (% intermediate cells)] + [0.2x (% parabasal cells)]. The comparison intra and inter groups will be between baseline values and 30 days values.
Measured: 30 days
Female Sexual Function Index (FSFI)
Female Sexual Function Index (FSFI) Romanian version, evaluated by Investigator and analysed considering the changing from baseline to 30 days (final visit) with comparison intra and inter groups.
Measured: 30 days
Sexual Function (SF 12)
SF 12 (Romanian version) evaluated by Investigator and analysed considering the changing from baseline to 30 day (final visit) with comparison intra and inter groups.
Measured: 30 days
Global Symptom Score (GSS)
Global Symptom Score (GSS) a composite score of symptoms, will be obtained to assess the effect of treatment on all individual symptoms taken as a whole. It will be calculated by the addition of the intensity scores of all individual symptoms (range, 1-15: 1 = only mild vaginal dryness, 15 = all five symptoms severe in intensity). This outcome will be compared intra and inter groups, assessing the changing from baseline visit to 30 days visit (final visit).
Measured: 30 days
Patient Global Assessment of Safety (PGAS)
Patient Global Assessment of Safety (PGAS): it will be reported by the subject at all visits and all phone contacts in the patient diary using the 4-point scale:
1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety.
Measured: 30 days
Investigator Global Assessment of Safety (IGAS)
Investigator Global Assessment of Safety (IGAS): it will be reported by the Investigator using the 4-point scale:
1= very good safety, 2 = good safety, 3 = moderate safety and 4 = poor safety. IGAS will be evaluated at the last visit, only.
Measured: 30 days
Adverse Event, Adverse Device Event, Serious Adverse Event, Suspected Adverse Device Event
AE, ADE, SAE, SADE: they will be reported by the Investigators according to the current legislation. All adverse events will be collected by Investigators at all visits and phone contacts and evaluated considering the change from baseline.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start11 Apr 2019
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an open-label, comparative, multicenter study with two parallel group of subjects. The clinical investigation will be performed in three clinical sites. The calculated sample size of subjects is 50 (25 subject for each arm). To obtain this number of evaluable subjects it will be needed to screen about 60 subjects (including 6 potential screening failure) and to enroll 54 subjects (estimating 4 subjects drop out). From the equal distribution per groups of treatment point of view, the minimum and maximum number of patients recommended for each of the three centers will be 8 and 25, respectively. The research question is: in a population of menopausal transition women affected by vaginal dryness, will a 1-month treatment with polycarbophilic vaginal gel (Ainara®) significantly decrease the symptomatology evaluated by VHI and VAS in comparison with that occurred in a group of patients treated with a HA-based gel (HyaloGyn®)?
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Italfarmaco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
- Investigators
- Liviu Cristian PĂTRAȘCU, Dr, Principal investigator, Fizio Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245293
- Sponsor's protocol ID
- DMS/18/AINARA/01
- Status last verified
- Jan 2020
- First submitted
- 27 Jan 2020
- Last updated
- 28 Jan 2020
- 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 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Comparative Study To Evaluate The Performance And Safety Of The Medical Device AINARA® Vaginal Gel Versus A Hyaluronic Acid-Based Gel In Late Menopausal Transition Women Affected By Vaginal Dryness
- ClinicalTrials.gov ID
- NCT04245293
- Acronym / sponsor ID
- DMS/18/AINARA/01
- Conditions
- Vaginal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- ItalfarmacoIndustry (pharma, biotech, devices)
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 28 Jan 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 study evaluates treatment with the medical device Ainara® compared to a HA-based gel (Hyalogin) on the improvement of vaginal dryness
Detailed description
This is an open, comparative, multicenter study that evaluates the performance and safety of the medical device Ainara®.
In this study we use polycarbophilic vaginal moisturizing gel (Ainara®) compared with a HA-based gel (Hyalogin) for symptomatic treatment of vaginal dryness and we will monitor its impact on vaginal dryness symptoms evaluated by Vaginal Health Index and Vaginal Analogue Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, comparative, multicenter study with two parallel group of subjects. The clinical investigation will be performed in three clinical sites. The calculated sample size of subjects is 50 (25 subject for each arm). To obtain this number of evaluable subjects it will be needed to screen about 60 subjects (including 6 potential screening failure) and to enroll 54 subjects (estimating 4 subjects drop out). From the equal distribution per groups of treatment point of view, the minimum and maximum number of patients recommended for each of the three centers will be 8 and 25, respectively. The research question is: in a population of menopausal transition women affected by vaginal dryness, will a 1-month treatment with polycarbophilic vaginal gel (Ainara®) significantly decrease the symptomatology evaluated by VHI and VAS in comparison with that occurred in a group of patients treated with a HA-based gel (HyaloGyn®)?
| Arm | Type | Receives |
|---|---|---|
| Ainara | Experimental | Device: AinaraExperimental: Ainara Each administration kit (subject kit) for patients of Ainara® will contain a box with 1 tube with 30 g gel, 1 cannula and 1 plunger. The gel quantity is enough for one subject over the course of the study (1 g at each administration). |
| HyaloGin | Active comparator | Device: HyaloGinActive Comparator: HyaloGin Each administration kit (subject kit) for patients allocated to HyaloGyn® group will contain a box with: 1 tube with 30g gel and 10 single-use applicators consisting of a piston and one opaque plastic plunger. The gel quantity is enough for one subject (3g application every three days over the course of the study). |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-pregnant and in menopausal transition period (late peri-menopause) women following the STRAW criteria and with a break in menstrual periods of at least 60 days, aged ≥ 45 to ≤ 55 years.
- Diagnosis of vaginal dryness by subjective dryness, any objective sign of VVA, pH>5 as reported in the AGATA study and VHI < 15.
- Body mass index of ≥ 18.5 to ≤ 36 kg/m2.
- Females of child bearing potential who agree to use only lubricated condoms or spiral as contraceptives methods, during the full duration of the study.
- Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.
Key exclusion criteria (12 listed)
- Women in post-menopausal (total cessation of menses for ≥ 1 year from the date of the screening visit).
- Malignancy (also leukemic infiltrates) within 5 years prior to day 0 (except for treated basal cell/squamous cell carcinoma of the skin).
- Genital bleeding.
- Estrogen vaginal treatment during the study period (permitted only if terminated at least 6 months before study).
- Systemic estrogen therapy (permitted only if terminated at least 6 months before 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 |
|---|---|---|
| AinaraEach administration kit (subject kit) for patients of Ainara® will contain a box with 1 tube with 30 g gel, 1 cannula and 1 plunger. The gel quantity is enough for one subject over the course of the study (1 g at each administration). | Device | Ainara |
| HyaloGinActive Comparator: HyaloGin Each administration kit (subject kit) for patients allocated to HyaloGyn® group will contain a box with: 1 tube with 30g gel and 10 single-use applicators consisting of a piston and one opaque plastic plunger. The gel quantity is enough for one subject (3g application every three days over the course of the study). | Device | HyaloGin |
Primary outcome
The Vaginal Health Index (VHI)
Time frame: 30 days
The changing from baseline to day 30 (final visit) for VHI mean value in each group separately and the changing in the Ainara® group in comparison with that occurred in HyaloGyn® group; The minim score is 5 and the maxim is is 25
Visual Analogue Scale (VAS)
Time frame: 30 days
The changing from baseline to day 3, 7, 21, 30 (final visit) for VAS mean value in each group separately and in the Ainara® group in comparison with that occurred in HyaloGyn® group. The minim score is 0 and the maxim score is 5, where 0 represents no symptoms and 3 represents severe symptoms
10 secondary outcomes
subjective symptoms
Time frame: 30 days
objective signs in the vaginal mucosa
Time frame: 30 days
Vaginal pH
Time frame: 30 days
Vaginal Trophism Maturation Value (MV)
Time frame: 30 days
Female Sexual Function Index (FSFI)
Time frame: 30 days
Sexual Function (SF 12)
Time frame: 30 days
Global Symptom Score (GSS)
Time frame: 30 days
Patient Global Assessment of Safety (PGAS)
Time frame: 30 days
Investigator Global Assessment of Safety (IGAS)
Time frame: 30 days
Adverse Event, Adverse Device Event, Serious Adverse Event, Suspected Adverse Device Event
Time frame: 30 days
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 28 Jan 2020.
- 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.
Liviu Cristian PĂTRAȘCU, Dr principal investigator
Fizio Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ainara and HyaloGin in people with Vaginal Disease, run by Italfarmaco at 1 site in Romania.
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 6 inclusion and 12 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 28 Jan 2020. 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 Romania. 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?
The Vaginal Health Index (VHI) (time frame: 30 days). 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 28 Jan 2020; AzTrials last refreshed its copy on 3 Nov 2026.