Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness

NCT ID: NCT05888116

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2023-10-18

Brief Summary

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®).

Detailed Description

This is a prospective, multicenter, randomized, controlled, double-blind clinical investigation to evaluate the safety and efficacy of a new hyaluronic acid-based vaginal moisturizer gel (medical device class IIb) in women with symptoms of vaginal atrophy and dryness, compared to a commonly used marketed vaginal moisturizer in gynecology clinics (Cumluade Hidratante Interno®), with a 1-month follow-up.

The participants will apply the single dose of vaginal moisturizer 3 times per week, every other day, preferably in the evening.

The investigators will monitor the evolution of vaginal symptoms, vaginal health using the Vaginal Health Index (VHI), sexual function using the Female Sexual Function Index (FSFI) questionnaire, and the safety and tolerability of the new class IIb medical device.

Conditions

Vaginal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hidratante HA

The investigational product consists of a new vaginal moisturizing gel (class IIb medical device) presented in the form of 5 ml single-dose containers. Each patient will be given 12 single-dose containers inside white boxes identified only with the patient code.

For each participant, the total duration of treatment will be 4 weeks.

Group Type: EXPERIMENTAL

Hidrante HA

Intervention Type: DEVICE

Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.

Cumlaude Hidratante Interno®

The investigational product is a marketed vaginal moisturizing gel (class IIb medical device) presented in the form of 5 ml single-dose containers. Each patient will be given 12 single-dose containers inside white boxes identified only with the patient code.

For each participant, the total duration of treatment will be 4 weeks.

Group Type: ACTIVE_COMPARATOR

Cumlaude Hidrante Interno®

Intervention Type: DEVICE

Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.

Interventions

Hidrante HA

Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.

Intervention Type: DEVICE

Cumlaude Hidrante Interno®

Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.

Intervention Type: DEVICE

Other Intervention Names

Experimental; Active comparator

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dermofarm, S.A.U

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Fasero, Ph

Role: PRINCIPAL_INVESTIGATOR

Clínica Corofas. Tomelloso. Ciudad Real

Locations

Corofas Menopause

Tomelloso, Ciudad Real, Spain

Countries

Spain

Other Identifiers

DFARM-HYDRA-HA-2022

Identifier Type: -

Identifier Source: org_study_id