Vaginal Disease Clinical Trial
— HYALU-LAUDEOfficial title:
Clinical Investigation to Evaluate the Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness
Verified date | September 2023 |
Source | Dermofarm, S.A.U |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the efficacy and safety of a new hyaluronic acid-based vaginal moisturizer gel to ease symptoms of vaginal dryness compared to a commonly used marketed vaginal moisturizer (Cumluade Hidratante Interno®).
Status | Completed |
Enrollment | 54 |
Est. completion date | October 18, 2023 |
Est. primary completion date | October 18, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Women over 18 years of age who manifest subjective symptoms of vaginal dryness (dryness, itching, burning/stinging and dyspareunia). - In the case of postmenopausal women, they must have a diagnosis confirmed by the gynecologist of the presence of signs of vulvovaginal dryness/atrophy (Vaginal Health Index score <15). - Patients who have not used any topical treatment, moisturizer or vaginal lubricant for at least 7 days prior to the start of the study and agree not to use it during the study period. - Patients who agree to participate and sign the Informed Consent form. Exclusion Criteria: - Pregnant women - Malignant neoplasm within 5 years prior to study entry (except for treated basal cell/squamous cell carcinoma of the skin). - Genital bleeding. - Treatment with vaginal or systemic estrogens in the 3 months prior to study inclusion or during the study period. I said above - Subjects with illness or other medical condition that, in the investigator's opinion, would compromise participation or could lead to hospitalization during the study. - Clinical evidence of acute infection that requires treatment (syphilis, herpes simplex, human papilloma virus, gonorrhea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (i.e., tuberculosis), with the exception of HPV-carrying women with no lesions. - Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except intermittent anxiety). - Known allergy to the components of the investigational product or its excipients. - Drug or alcohol abuse in the 12 months prior to the start of the study. - Participation in an interventional clinical study or administration of any investigational agent within the previous 30 days. - Patients with low expectation of compliance with the study protocol. |
Country | Name | City | State |
---|---|---|---|
Spain | Corofas Menopause | Tomelloso | Ciudad Real |
Lead Sponsor | Collaborator |
---|---|
Dermofarm, S.A.U |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vaginal Health Index | The Vaginal Health Index ranges from a minimum of 5 to a maximum of 25. The change will be assessed by comparing scores from baseline to 30 days (final visit); with comparison intra and inter groups. | At the end of study (Day 30) | |
Secondary | Severity of subjective symptoms (investigator record) | Severity of dryness, itching, burning and dyspareunia reported by the investigator in the data registration form, assessed using a visual analog scale (VAS from 0=none to 10=maximum).The change will be assessed by comparing scores from baseline to day 7 and to day 30; with comparison intra and inter groups. | at 7 days and 30 days. | |
Secondary | Subjective symtomps (patient's notebook) | Severity of dryness, itching, burning and dyspareunia reported on patient diary using a 4-point Likert scales (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The change will be assessed by comparing scores from baseline to every record (3 days, 7days, 14 days, 21 days and 30 days); with comparison intra and inter groups. | at 3 days, 7days, 14 days, 21 days and 30 days. | |
Secondary | Objective signs of vulvovaginal atrophy | Objective signs of vulvovaginal atrophy (dryness, flattening of folds, mucosal pallor, frailty and petechiae) reported by the investigator in the data registration form, assessed using a 4-point Likert scales (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The change will be assessed by comparing scores from baseline to day 7 and to day 30; with comparison intra and inter groups. | at 7 days and 30 days. | |
Secondary | Vaginal pH | Vaginal pH will be measured by the investigator with a test strip delivered by sponsor. The change will be assessed by comparing pH values from baseline to day 30; with comparison intra and inter groups. | At the end of study (Day 30) | |
Secondary | Sexual function | Female Sexual Function Index (FSFI) questionnaire will be answered by the patients at the baseline and 30-day visits. The change will be assessed by comparing FSFI scores from baseline to day 30; with comparison intra and inter groups. | At the end of study (Day 30) | |
Secondary | Global Symptom Score (GSS) | Global Symptom Score (GSS) will be assessed by the sum of severity scores of each symptom: dryness, itching, burning/stinging and dyspareunia (0 = none, 1 = mild, 2 = moderate and 3 = severe). GSS score ranges from 0 to 12. The change will be assessed by comparing GSS scores from baseline to day 30; with comparison intra and inter groups. | At the end of study (Day 30) | |
Secondary | Adverse events as a measure of Safety and Tolerability | Number of participants with incidence of treatment-related adverse events, serious adverse events and device deficiencies as a Measure of Safety and Tolerability. | At the end of study (Day 30) | |
Secondary | Overall Safety Assessment | Overall patient and investigator safety rating, using 4-point Likert-type scale (1 = very good, 2 = good, 3 = moderate, 4 = poor, 5=very poor); with comparison inter groups. | At the end of study (Day 30) | |
Secondary | Patient satisfaction | The patient's degree of satisfaction with the product will be rated using a 5-point Likert-type scale (1 = very satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5=very dissatisfied); with comparison inter groups. | At the end of study (Day 30) |
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