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

February 4, 2026 updated by: i+Med S.Coop.

Efficacy and Safety of BtH Intimate 2.0% (Injectable Cross-Linked Hyaluronic Acid) in the Volumization and Aesthetic Rejuvenation of the Female Vulvovaginal Area: A Prospective Clinical Investigation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28805
        • Complutense Medical Center (Virtus Group)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • Incorrectly selected participants (those found retrospectively to fail inclusion or meet exclusion criteria) will be replaced.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BtHIntimate® Injectable Hyaluronic Acid Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Global Aesthetic Improvement (GAIS)
Time Frame: Baseline to 12 weeks and 24 weeks
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)
Time Frame: 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Satisfaction (Likert Scale)
Time Frame: Immediatly post-treatment, at 4 weeks, at 12 weeks and at 24 weeks
A 5 point Likert Scale (Very satisfied, Satisfied, Slightly satisfied, indifferent and unsatisfied). The percentage of very satisfied, satisfied and slightly satisfied answers was taken into account.
Immediatly post-treatment, at 4 weeks, at 12 weeks and at 24 weeks
Investigator-Rated Aesthetic Parameters with a Visual Analogue Scale (VAS)
Time Frame: Baseline, 4 weeks, 12 weeks, 24 weeks
Clinical assessment of improvement in aesthetic parameters using a visual analogue scale (VAS 0-10): volume, hydration, elasticity, hyperpigmentation, and firmness. Improvement will be calculated as the change in points from baseline.
Baseline, 4 weeks, 12 weeks, 24 weeks
Female Sexual Function Index (FSFI)
Time Frame: Baseline, 4 weeks, 12 weeks, 24 weeks
The FSFI consists of 19 multiple-choice questions coded from 0.0 to 5.0. Each score has a specific meaning depending on the item. The scale includes six sexual domains. The maximum score for each domain is 6.0, obtained by summing the item responses and multiplying by a correction factor. The total composite sexual function score is the sum of all domain scores and ranges from 2.0 (not sexually active and no desire) to 36.0. Improvement will be calculated as the change in points from baseline.
Baseline, 4 weeks, 12 weeks, 24 weeks
Vulvovaginal Symptoms (VAS)
Time Frame: Baseline, 4 weeks, 12 weeks, 24 weeks
Vulvovaginal symptoms assessed using a 0-10 visual analogue scale (VAS). The following symptoms are evaluated: itching, friction or rubbing associated with atrophy, dryness, pain, sensitivity, tingling, and dyspareunia. Improvement will be calculated as the change in points from baseline.
Baseline, 4 weeks, 12 weeks, 24 weeks
PGI-I (Patient Global Impression of Improvement)
Time Frame: Time Frame: 4 weeks, 12 weeks, 24 weekS
Patient's global impression of improvement using 7-point PGI-I scale (1 = "very much improved" to 7 = "very much worse"). Responders are scores 1 (Very much improved), 2 (Much improved) and 3 (Improved).
Time Frame: 4 weeks, 12 weeks, 24 weekS
Hydration of Vulvar Tissue (Corneometer®)
Time Frame: Baseline, 4 weeks, 12 weeks, 24 weeks
Hydration of the treated area measured using a Corneometer® biometric probe. Improvement will be calculated relative to baseline values."
Baseline, 4 weeks, 12 weeks, 24 weeks
Non-Serious Adverse Events (AEs)
Time Frame: 6 months
Frequency, severity, duration, and investigator-determined causality of all non-serious adverse events (e.g., erythema, swelling, bruising, palpable nodules).
6 months
Future Use Questionnaire
Time Frame: 24 weeks
Participant-reported acceptance and willingness to use the product again or recommend it, including purchase intention and perceived effectiveness.
24 weeks
Usability Assessment (Investigator)
Time Frame: 24 weeks
Investigator evaluation of device usability, including syringe handling, injection force, ergonomics, packaging, and product flow through the cannula.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
i+Med S.Coop.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dr. Goya Análisis, SL.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 22, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BtHCi-PIC01-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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