Meta description: A completed clinical study evaluates BtHIntimate® Injectable Hyaluronic Acid Treatment for vulvar atrophy, detailing safety measures and the potential for aesthetic vulvovaginal rejuvenation.
Publication date context: 2026 02 11 14 17 51 Z. A regulatory note summarizes a completed study evaluating BtHIntimate® Injectable Hyaluronic Acid Treatment for vulvar atrophy. The trial record on ClinicalTrials.gov lists i+Med S.Coop. and Dr. Goya Análisis, SL as sponsors. The intervention is defined as a Device BtHIntimate® Injectable Hyaluronic Acid Treatment and the status is Completed. Readers should understand that the source text does not publish trial results. The external link to the ClinicalTrials.gov page is provided for official information: ClinicalTrials.gov record NCT07402395.
What is the BtHIntimate Injectable Hyaluronic Acid device and what condition was studied?
Device description and intended use
The BtHIntimate® Injectable Hyaluronic Acid Treatment is presented as a medical device that delivers hyaluronic acid via injections to the vulvar region. The intended indication centers on improving the aesthetic rejuvenation of the vulvovaginal area in adults with vulvar atrophy.
The clinical trial record identifies the study population as individuals with vulvar atrophy and lists the intervention as a device based hyaluronic acid injection. Sponsors are i+Med S.Coop. and Dr. Goya Análisis, SL. The public trial page provides the entry point to the official record: ClinicalTrials.gov record NCT07402395.
How were safety and efficacy assessed in the study?
Study design and endpoints
The record specifies a safety and efficacy focus for the BtHIntimate® device. Specific endpoints and methodological details are not provided in the source text. The description indicates that the assessment aimed to gather safety data and to explore potential efficacy signals related to vulvar aesthetic rejuvenation.
Interpretation of the data in regulatory terms
Because the source text does not disclose results, readers should regard the information as a summary of the trial’s existence and status. Any conclusions about safety performance or efficacy must await official disclosures from the sponsor or the trial registry.
What is the trial status and who funded the study?
Status and completion
The entry shows that the study is completed. Completion indicates that data collection as described in the protocol has concluded. No trial results are presented in the source text.
Sponsors and organizational context
Sponsors listed for the trial include i+Med S.Coop. and Dr. Goya Análisis, SL. These entities may be involved in device development, clinical investigation oversight, or data management, in line with standard good clinical practice requirements. The public record provides the sponsor information for oversight and accountability purposes.
What is the regulatory context for this device in a clinical trial?
Intended purpose and performance parameters
Under regulatory practice the record notes the intended purpose of BtHIntimate® Injectable Hyaluronic Acid Treatment as a device based intervention for vulvar atrophy related aesthetic improvement. Performance expectations and safety considerations would be evaluated in the ongoing regulatory process, with the current record serving as a documentation point for safety and basic performance indicators.
Manufacturers statements and regulatory expectations
Any manufacturer statements in the source text are noted as such. The MDR style emphasizes clear statements of intended use, performance claims and safety data. The absence of trial results means that regulatory decision making would rely on official disclosures or subsequent data releases.
FAQ
1. What device is studied for vulvar atrophy? The BtHIntimate® Injectable Hyaluronic Acid Treatment as described in the ClinicalTrials.gov record.
2. What condition is addressed by the study? Vulvar atrophy and related aesthetic considerations in adults.
3. What is the status of the trial? The record indicates completion of the study.
4. Who sponsors the study? i+Med S.Coop. and Dr. Goya Análisis, SL are listed as sponsors.
5. Where can I find official information? The principal registry is ClinicalTrials.gov, entry NCT07402395, accessible online.
Conclusion
The record confirms that a completed trial exists for BtHIntimate® Injectable Hyaluronic Acid Treatment in the vulvar atrophy setting. No trial results are provided in the source text. Stakeholders should monitor the sponsor communications and the ClinicalTrials.gov page for official safety and performance disclosures.
Disclaimer
This article is intended for professional audiences and is based on the source text. It does not constitute legal advice or a formal regulatory ruling. Seek qualified regulatory counsel for device specific guidance.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07402395?term=medical+device