Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT04659668
Eligibility Criteria:
Inclusion Criteria:
* 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:
* Signed written Informed Consent Form
Exclusion Criteria:
* 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;
* 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04659668
Study Brief:
Protocol Section:
NCT04659668