Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and Atrophy of the Vagina.

NCT04659668 | Completed

• 1 other identifier: MD/MMG-23-04-2019
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaginal Atrophy; Vulvovaginal Signs and Symptoms; Dyspareunia; Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• Vaginal Maturation Index (VMI) absolute change

  Improvement in the properties of the vaginal wall, measured by the VMI.

  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

  From screening through study completion, an average of 60 days - daily.

Secondary Outcomes (8)

• The change in the Gloria Bachmann Vaginal Health Index (VHI)

  From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks).

• The absolute change in Visual Analogous Scale (VAS).

  From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks).

• The absolute change in Visual Analogous Scale (VAS)

  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.

  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

  From Day 30 (4 weeks) to Day 60 (up to 8 weeks).

Study Arms (1)

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.

Device: MMG-23-04-2019

Interventions

MMG-23-04-2019 DEVICE

The dermal filler MMG-23-04-2019 is applied to the female intimate area (intramucosal administration) of vaginal vestibule, vaginal walls, clitoris, "G" spot.

MMG-23-04-2019

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender-based pathology.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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:

You may not qualify if:

• 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;
• 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;
• Subject with limited mental activity and consistent comprehension ability; sportsmen and individuals on strenuous physical loading; prisoners;
• Refusal to sign the Informed Consent Form.

Sponsors & Collaborators

• Mesoestetic Pharma Group S.L.: lead

Study Sites (1)

Medical Centre Ramus

Sofia, 1592, Bulgaria

Location

MeSH Terms

Conditions

Dyspareunia; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 9, 2020
• Study Start: November 11, 2019
• Primary Completion: June 12, 2020
• Study Completion: August 17, 2020
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)