Clinical Study on the Safety and Efficacy of an Injectable Hyaluronic Acid for Improving the Aesthetic Rejuvenation of the Vulvovaginal Area

NCT07402395 | Completed

• 1 other identifier: BtHCi-PIC01-2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-center, before-after study evalutated BtH Intimate 2.0%, a cross-linked hyaluronic acid injectable used to restore volume and improve the aesthetic appearance and hydration of the vulvovaginal area in adult women. Forty participants with mild to moderate vulvar atrophy or genital aging signs received a single treatment, with an optional touch-up at 4 weeks, and were followed for six months. The primary objectives were to measure global aesthetic improvement using the GAIS scale and to assess safety through the recording of serious adverse events. Secondary measures included patient satisfaction, sexual function (FSFI), symptom improvement (VAS), tissue hydration, and overall patient-reported benefit. Expected risks were mild and transient, consistent with HA fillers, while the intervention aimed to enhance comfort, appearance, and quality of life.

Conditions

Vulvar Atrophy

Outcome Measures

Primary Outcomes (2)

• Global Aesthetic Improvement (GAIS)

  Aesthetic improvement of the vulvovaginal area assessed by the investigator using the 5-point Global Aesthetic Improvement Scale (GAIS: "very much improved," "much improved," "improved," "no change," "worse"). Clinical relevance is defined as ≥60% of participants rated as "Improved" or better at week 12 or 24.

  Baseline to 12 weeks and 24 weeks

• Incidence of Serious Adverse Events (SAEs)

  Number, frequency, severity, and relationship of all serious adverse events recorded according to EU MDR definitions (death, life-threatening events, hospitalization, permanent impairment, or fetal harm).

  6 months

Secondary Outcomes (9)

• Patient Satisfaction (Likert Scale)

  Immediatly post-treatment, at 4 weeks, at 12 weeks and at 24 weeks

• Investigator-Rated Aesthetic Parameters with a Visual Analogue Scale (VAS)

  Baseline, 4 weeks, 12 weeks, 24 weeks

• Female Sexual Function Index (FSFI)

  Baseline, 4 weeks, 12 weeks, 24 weeks

• Vulvovaginal Symptoms (VAS)

  Baseline, 4 weeks, 12 weeks, 24 weeks

• PGI-I (Patient Global Impression of Improvement)

  Time Frame: 4 weeks, 12 weeks, 24 weekS

Study Arms (1)

BtHIntimate® Injectable Hyaluronic Acid Treatment

EXPERIMENTAL

Participants in this single-arm study will receive a single intradermal infiltration of BtH Intimate 2.0% intended to restore volume and improve the aesthetic appearance, hydration, and firmness of the vulvovaginal area.

Device: BtHIntimate® Injectable Hyaluronic Acid Treatment

Interventions

BtHIntimate® Injectable Hyaluronic Acid Treatment DEVICE

BtHIntimate 2.0% is administered to the labia majora and/or mons pubis according to individual clinical needs. An optional touch-up may be performed at the 4-week follow-up visit if deemed necessary by the investigator. All participants are followed for 6 months, during which aesthetic outcomes, tissue hydration, patient-reported symptoms, sexual function, satisfaction, and safety events are evaluated.

BtHIntimate® Injectable Hyaluronic Acid Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women (≥18 years).
• Women with mild or moderate vulvar atrophy, including deflation or vulvar ptosis, or with visible signs of genital aging, or women seeking aesthetic improvement of the vulvovaginal area, including peri-menopausal or women with genitourinary syndrome of menopause (GSM).
• Ability and willingness to comply with all study visits and procedures.
• Sufficient predisposition and capacity, in the investigator's judgment, to complete study questionnaires.
• For women of childbearing potential: negative pregnancy test and agreement to use reliable contraception during the study (hormonal contraception, IUD/IUS, condoms, diaphragm with spermicide, vasectomized partner, or true abstinence).

You may not qualify if:

• Allergy or hypersensitivity to any component of BtH Intimate 2.0%.
• Pregnancy or planned pregnancy, or breastfeeding.
• Active infection or pathology in the area to be treated.
• Presence of bacterial, fungal, or viral infection in or near the vulvovaginal region, or current treatment for such conditions.
• Known tendency to develop hypertrophic scars or keloids.
• Signs of inflammation in or near the treatment area, or receiving treatment for inflammation.
• History of any vulvovaginal rejuvenation procedure within the last 6 months or during the study (e.g., laser, radiofrequency, electrotherapy, dermal fillers, PRP, etc.).
• Unrealistic or disproportionate expectations regarding treatment outcomes.

Sponsors & Collaborators

• i+Med S.Coop.: lead
• Dr. Goya Análisis, SL.: collaborator

Study Sites (1)

Complutense Medical Center (Virtus Group)

Madrid, Madrid, 28805, Spain

Location

Study Design

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

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: November 22, 2024
• Primary Completion: September 2, 2025
• Study Completion: November 26, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)