Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and⦠(NCT04659668) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and Atrophy of the Vagina.
Bulgaria37 participantsStarted 2019-11-11
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female subject aged ā„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;
* 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
Exclusion Criteria:
* Subject with known sensitivity to hyaluronic acid or significant hypersensitivity to food and drugs;
* Subā¦
What they're measuring
1
Vaginal Maturation Index (VMI) absolute change
Timeframe: From baseline to Day 60 (up to 8 weeks).
2
Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: From screening through study completion, an average of 60 days - daily.