Vulvar AtrophyNCT07402395
Clinical Study on the Safety and Efficacy of an Injectable Hyaluronic Acid for Improving the Aesthetic Rejuvenation of the Vulvovaginal Area
A study testing BtHIntimate® Injectable Hyaluronic Acid Treatment in people with Vulvar Atrophy, run by i+Med S.Coop. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vulvar Atrophy
- What is being tested?
- BtHIntimate® Injectable Hyaluronic Acid Treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 22 Nov 2024to 26 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vulvar Atrophy
- Being tested
- BtHIntimate® Injectable Hyaluronic Acid Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BtHIntimate® Injectable Hyaluronic Acid TreatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BtHIntimate® Injectable Hyaluronic Acid Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 6 months
Secondary outcomes (9)
Patient Satisfaction (Likert Scale)
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.
Measured: Immediatly post-treatment, at 4 weeks, at 12 weeks and at 24 weeks
Investigator-Rated Aesthetic Parameters with a Visual Analogue Scale (VAS)
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.
Measured: Baseline, 4 weeks, 12 weeks, 24 weeks
Female Sexual Function Index (FSFI)
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.
Measured: Baseline, 4 weeks, 12 weeks, 24 weeks
Vulvovaginal Symptoms (VAS)
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.
Measured: Baseline, 4 weeks, 12 weeks, 24 weeks
PGI-I (Patient Global Impression of Improvement)
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).
Measured: Time Frame: 4 weeks, 12 weeks, 24 weekS
Hydration of Vulvar Tissue (Corneometer®)
Hydration of the treated area measured using a Corneometer® biometric probe. Improvement will be calculated relative to baseline values."
Measured: Baseline, 4 weeks, 12 weeks, 24 weeks
Non-Serious Adverse Events (AEs)
Frequency, severity, duration, and investigator-determined causality of all non-serious adverse events (e.g., erythema, swelling, bruising, palpable nodules).
Measured: 6 months
Future Use Questionnaire
Participant-reported acceptance and willingness to use the product again or recommend it, including purchase intention and perceived effectiveness.
Measured: 24 weeks
Usability Assessment (Investigator)
Investigator evaluation of device usability, including syringe handling, injection force, ergonomics, packaging, and product flow through the cannula.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start22 Nov 2024
- Primary completion2 Sep 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvar AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- i+Med S.Coop.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Goya Análisis, SL.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402395
- Sponsor's protocol ID
- BtHCi-PIC01-2024
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07402395
- Acronym / sponsor ID
- BtHCi-PIC01-2024
- Conditions
- Vulvar Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- i+Med S.Coop.Industry (pharma, biotech, devices)
- Collaborators
- Dr. Goya Análisis, SL.
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 2 Sep 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BtHIntimate® Injectable Hyaluronic Acid Treatment | Experimental | Device: BtHIntimate® Injectable Hyaluronic Acid TreatmentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BtHIntimate® Injectable Hyaluronic Acid TreatmentBtHIntimate 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. | Device | BtHIntimate® Injectable Hyaluronic Acid Treatment |
Primary outcome
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.
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).
9 secondary outcomes
Patient Satisfaction (Likert Scale)
Time frame: 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
Female Sexual Function Index (FSFI)
Time frame: Baseline, 4 weeks, 12 weeks, 24 weeks
Vulvovaginal Symptoms (VAS)
Time frame: Baseline, 4 weeks, 12 weeks, 24 weeks
PGI-I (Patient Global Impression of Improvement)
Time frame: Time Frame: 4 weeks, 12 weeks, 24 weekS
Hydration of Vulvar Tissue (Corneometer®)
Time frame: Baseline, 4 weeks, 12 weeks, 24 weeks
Non-Serious Adverse Events (AEs)
Time frame: 6 months
Future Use Questionnaire
Time frame: 24 weeks
Usability Assessment (Investigator)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Vulvar Atrophy
Not yet recruitingObservational study
Retrospective Cohort Study of Symptoms and Quality of Life in Women With Genitourinary Syndrome of Menopause.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Active, not recruiting
Laser Vaginal Treatment for GSM
Menopausal Urethral Atrophy, Vulvar Atrophy
Recruiting
Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
Vulvar Atrophy, Vulvovaginal Signs and Symptoms
Not yet recruiting
Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Lichen Sclerosus Treated With Fat Grafting
Vulvar Lichen Sclerosus, Vulvar Atrophy
Recruiting
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Atrophic Vaginitis, Vaginal Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BtHIntimate® Injectable Hyaluronic Acid Treatment in people with Vulvar Atrophy, run by i+Med S.Coop. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Aesthetic Improvement (GAIS) (time frame: Baseline to 12 weeks and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.