Vaginal AtrophyNCT04659668
Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and Atrophy of the Vagina.
A study testing MMG-23-04-2019 in people with Vaginal Atrophy and Vulvovaginal Signs and Symptoms, run by Mesoestetic Pharma Group S.L. at 1 site in Bulgaria.
Trial summary
The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMG-23-04-2019" on the female genital area for the medicinal, functional and reconstructive indications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Atrophy, Vulvovaginal Signs and Symptoms, Dyspareunia
- What is being tested?
- MMG-23-04-2019
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteBulgaria
- Study dates
- 11 Nov 2019to 17 Aug 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subject aged ≥18;
- Subject presenting vaginal atrophy, dryness, dyspareunia or discomfort in the intimate area;
- Subject who presents no other type of pathology of the area to be treated;
- Subject who is willing to abstain from any cosmetic or surgical procedures in the treatment area during the clinical investigation;
- Subject who is willing to participate in all study related activities and who is available for the duration of their participation in the investigation for follow-up;
- Absence of a history of significant hypersensitivity to food and drugs or known sensitivity to hyaluronic acid;
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- Clinically and anamnestic healthy individual;
- Arterial blood pressure (BP) (after 5 min. at rest in the supine position) systolic 90 - 140 mmHg and diastolic 50 - 90 mmHg;
- Heart rate (HR) (after 5 min. at rest in the supine position) over 50 beats/min and less than 90 beats/min;
- Respiratory rate between 12 - 24 breaths/min;
- An axillar body temperature of up to 37 degrees celsius;
- Clinical-laboratory examinations within the reference ranges or with no clinically significant abnormalities;
- Negative AIDS/HIV test;
- Negative pregnancy test for the women with reproductive potential;
- A reliable and acceptable method of contraception for the women of child-bearing potential:
- Signed written Informed Consent Form
Who cannot join
- Subject with known sensitivity to hyaluronic acid or significant hypersensitivity to food and drugs;
- Subject with a history of vulvar cancer and/or previous regional radiotherapy;
- Subject with genital prolapse with a surgical indication or stress incontinence with a surgical indication;
- A subject who suffers from vaginism;
- Subject with genital bleeding of unknown origin;
- Subject with frequent or present active herpes simplex or herpes zoster local infection or active herpes simplex or herpes zoster infection in other sites;
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- Subject with a history of frequent or active local dermatitis (of the injection site), vulvar scaly papilloma, mycosis; bacterial infection or laboratory tests indicating for such;
- A subject suffering from autoimmune diseases or who are undergoing treatment with immunosuppressors or immunotherapy;
- Subject with uncontrolled systemic diseases or who are undergoing current treatment with antihypertensives, steroid anti-inflammatory drugs anticoagulants, aspirin, major antidepressants;
- Pregnancy, postpartum period (6 months), lactation or post-lactation period (6 months);
- Absence of a reliable and effective method of contraception for a subject with childbearing potential;
- Subjects who are currently receiving another investigational treatment or who had participated in another clinical investigation within 30 days prior to study enrollment;
- A subject who suffer from another medical condition or who are receiving medication that in the Principal Investigator's judgment would prohibit the inclusion in the study;
- Subject with limited mental activity and consistent comprehension ability; sportsmen and individuals on strenuous physical loading; prisoners;
- Refusal to sign the Informed Consent Form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Uncontrolled Single Centre Study for the Evaluation of the Performance Characteristics (Efficacy and Safety) of the Dermal Filler MMG-23-04-2019 (Hyaluronic Acid 2,0%) for Female Intimate Area Hydration and Atrophy of the Vagina.
The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMG-23-04-2019" on the female genital area for the medicinal, functional and reconstructive indications.
Read the detailed description
The Dermal Filler is recommended for the female intimate areas, especially the internal area of the vagina (vaginal vestibule, introitus, vaginal walls, clitoris, "G" spot) for the following indications: vaginal dryness or discomfort, vaginal atrophy.
The main functional ingredient is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation.
The MMG-23-04-2019 is contained in pre-filled, graduated and disposable sterile syringe with Luer Lock adapter with 1 ml of net content and 20 mg/ml hyaluronic acid.
The MMG-23-04-2019 has been classified as a Class III medical device under Annex IX of Directive MDD 93/42 EEC since it is a long-term, invasive and absorbable medical device.
- Being tested
- MMG-23-04-2019
- Medical subject headings
- Dyspareunia, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMG-23-04-2019Device
The dermal filler MMG-23-04-2019 is applied to the female intimate area (intramucosal administration) of vaginal vestibule, vaginal walls, clitoris, "G" spot.
| Study group | Role | What they receive |
|---|---|---|
| MMG-23-04-2019 | Experimental | MMG-23-04-2019 is composed by sodium hyaluronate at concentration of 2% (20 mg/ml) with 1,4-Butanediol diglycidyl ether (BDDE) acting as a cross-linking agent, in aqueous solution at physiological pH. The filler of 1ml is administered once or twice depending on the individual necessity. Receives: Device: MMG-23-04-2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Maturation Index (VMI) absolute change
Improvement in the properties of the vaginal wall, measured by the VMI.
Measured: From baseline to Day 60 (up to 8 weeks).
Treatment-Emergent Adverse Events [Safety and Tolerability]
Frequency and severity of adverse events (AEs) and adverse device effect
Measured: From screening through study completion, an average of 60 days - daily.
Secondary outcomes (8)
The change in the Gloria Bachmann Vaginal Health Index (VHI)
The VHI is a score formed by 5 parameters (vaginal elasticity, vaginal secretions, pH, epithelial mucous membrane, vaginal hydration). The final score defines the degree of atrophy in the genitourinary tract by assigning a single score to each parameter. The maximum possible score is 25, while the minimum possible score is 5.
Measured: From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks).
The absolute change in Visual Analogous Scale (VAS).
The absolute change in VAS, ranged between 0 (no pain) and 10 (worst possible pain), judged by the Principal Investigator.
Measured: From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks).
The absolute change in Visual Analogous Scale (VAS)
The absolute change in VAS ranged between 0 (no pain) and 10 (worst possible pain), judged by the subject.
Measured: From Day 0 to Day 30 (4 weeks) and Day 60 (up to 8 weeks).
The change of the Female Sexual Function Index (FSFI) score.
The FSFI is a validated questionnaire to measure the sexual functioning of women. The score ranges between 2 (minimum) and 36 (maximum).
Measured: From Day 0 to Day 30 and Day 60 (up to 4 weeks and 8 weeks respectively).
Subject satisfaction evaluated by the Global Impression of Improvement (PGI-I) questionnaire
The PGI-I is a transition single question scale, asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better) to 7 (Very much worse)
Measured: From Day 30 (4 weeks) to Day 60 (up to 8 weeks).
The change if the Nugent Score
The Nugent Score is a Gram stain scoring system for vaginal swabs to diagnose bacterial vaginosis, relying on scoring of individual types of organisms; a score of 0 to 10 is derived from a weighted combination of the following: large Gram-positive rods (lactobacilli; decrease in Lactobacillus scored as 0 to 4), small Gram-negative or Gram-variable rods (G. vaginalis or other anaerobes; scored as 0 to 4), and curved Gram-negative or Gram-variable rods (Mobiluncus spp.; scored as 0 to 2).
Measured: From baseline to Day 60 (up to 8 weeks).
Viganal biopsy (optional)
Evaluation of the mitotic activity of the mucosa (Ki-67 proliferation marker - %).
Measured: From Day 0 up to Day 60 (up to 8 weeks).
Participant's Questionnaire
To register the overall discomfort and satisfaction of the subjects.
Measured: From Day 0 to Day 30 and Day 60 (up to week 4 and 8 respectively).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start11 Nov 2019
- Primary completion12 Jun 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal 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
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoestetic Pharma Group S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659668
- Sponsor's protocol ID
- MD/MMG-23-04-2019
- Status last verified
- Dec 2020
- First submitted
- 20 Nov 2020
- Last updated
- 9 Dec 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 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Uncontrolled Single Centre Study for the Evaluation of the Performance Characteristics (Efficacy and Safety) of the Dermal Filler MMG-23-04-2019 (Hyaluronic Acid 2,0%) for Female Intimate Area Hydration and Atrophy of the Vagina.
- ClinicalTrials.gov ID
- NCT04659668
- Acronym / sponsor ID
- MD/MMG-23-04-2019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Mesoestetic Pharma Group S.L.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 9 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.
The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMG-23-04-2019" on the female genital area for the medicinal, functional and reconstructive indications.
Detailed description
The Dermal Filler is recommended for the female intimate areas, especially the internal area of the vagina (vaginal vestibule, introitus, vaginal walls, clitoris, "G" spot) for the following indications: vaginal dryness or discomfort, vaginal atrophy.
The main functional ingredient is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation.
The MMG-23-04-2019 is contained in pre-filled, graduated and disposable sterile syringe with Luer Lock adapter with 1 ml of net content and 20 mg/ml hyaluronic acid.
The MMG-23-04-2019 has been classified as a Class III medical device under Annex IX of Directive MDD 93/42 EEC since it is a long-term, invasive and absorbable medical device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| MMG-23-04-2019 | Experimental | Device: MMG-23-04-2019MMG-23-04-2019 is composed by sodium hyaluronate at concentration of 2% (20 mg/ml) with 1,4-Butanediol diglycidyl ether (BDDE) acting as a cross-linking agent, in aqueous solution at physiological pH. The filler of 1ml is administered once or twice depending on the individual necessity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female subject aged ≥18;
- Subject presenting vaginal atrophy, dryness, dyspareunia or discomfort in the intimate area;
- Subject who presents no other type of pathology of the area to be treated;
- Subject who is willing to abstain from any cosmetic or surgical procedures in the treatment area during the clinical investigation;
- Subject who is willing to participate in all study related activities and who is available for the duration of their participation in the investigation for follow-up;
Key exclusion criteria (15 listed)
- Subject with known sensitivity to hyaluronic acid or significant hypersensitivity to food and drugs;
- Subject with a history of vulvar cancer and/or previous regional radiotherapy;
- Subject with genital prolapse with a surgical indication or stress incontinence with a surgical indication;
- A subject who suffers from vaginism;
- Subject with genital bleeding of unknown origin;
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 |
|---|---|---|
| MMG-23-04-2019The dermal filler MMG-23-04-2019 is applied to the female intimate area (intramucosal administration) of vaginal vestibule, vaginal walls, clitoris, "G" spot. | Device | MMG-23-04-2019 |
Primary outcome
Vaginal Maturation Index (VMI) absolute change
Time frame: From baseline to Day 60 (up to 8 weeks).
Improvement in the properties of the vaginal wall, measured by the VMI.
Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From screening through study completion, an average of 60 days - daily.
Frequency and severity of adverse events (AEs) and adverse device effect
8 secondary outcomes
The change in the Gloria Bachmann Vaginal Health Index (VHI)
Time frame: From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks).
The absolute change in Visual Analogous Scale (VAS).
Time frame: From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks).
The absolute change in Visual Analogous Scale (VAS)
Time frame: From Day 0 to Day 30 (4 weeks) and Day 60 (up to 8 weeks).
The change of the Female Sexual Function Index (FSFI) score.
Time frame: From Day 0 to Day 30 and Day 60 (up to 4 weeks and 8 weeks respectively).
Subject satisfaction evaluated by the Global Impression of Improvement (PGI-I) questionnaire
Time frame: From Day 30 (4 weeks) to Day 60 (up to 8 weeks).
The change if the Nugent Score
Time frame: From baseline to Day 60 (up to 8 weeks).
Viganal biopsy (optional)
Time frame: From Day 0 up to Day 60 (up to 8 weeks).
Participant's Questionnaire
Time frame: From Day 0 to Day 30 and Day 60 (up to week 4 and 8 respectively).
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 9 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMG-23-04-2019 in people with Vaginal Atrophy and Vulvovaginal Signs and Symptoms, run by Mesoestetic Pharma Group S.L. at 1 site in Bulgaria.
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 16 inclusion and 15 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 9 Dec 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 Bulgaria. 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?
Vaginal Maturation Index (VMI) absolute change (time frame: From baseline to Day 60 (up to 8 weeks).). 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 9 Dec 2020.