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Filler for feminine rejuvenation: new study tests hyaluronic acid injections

NCT ID NCT07402395

Symptom relief Sponsor: i+Med S.Coop. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a hyaluronic acid filler (BtH Intimate 2.0%) injected into the labia and pubic area of 40 women with mild to moderate vulvar atrophy. The goal was to restore volume, improve appearance, and ease symptoms. Participants were followed for 6 months after a single treatment, with an optional touch-up at 4 weeks. The study measured aesthetic improvement, safety, patient satisfaction, and sexual function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cross-linked hyaluronic acid (BtH Intimate 2.0%)
What this could lead to
If it works, this could offer a non-surgical option to improve comfort, appearance, and quality of life for women with vulvar atrophy.
What could go wrong
This is a small, single-center study with no control group. Results may not apply to all women, and long-term effects beyond 6 months are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Nov 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

vulvar dystrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vulvar atrophy

Contacts and locations

Locations

  • Complutense Medical Center (Virtus Group)

    Madrid, Madrid, 28805, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.