Trials / Completed
CompletedNCT04659668
Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and Atrophy of the Vagina.
An Open-Label Uncontrolled Single Centre Study for the Evaluation of the Performance Characteristics (Efficacy and Safety) of the Dermal Filler MMG-23-04-2019 (Hyaluronic Acid 2,0%) for Female Intimate Area Hydration and Atrophy of the Vagina.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- Mesoestetic Pharma Group S.L. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMG-23-04-2019" on the female genital area for the medicinal, functional and reconstructive indications.
Detailed description
The Dermal Filler is recommended for the female intimate areas, especially the internal area of the vagina (vaginal vestibule, introitus, vaginal walls, clitoris, "G" spot) for the following indications: vaginal dryness or discomfort, vaginal atrophy. The main functional ingredient is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation. The MMG-23-04-2019 is contained in pre-filled, graduated and disposable sterile syringe with Luer Lock adapter with 1 ml of net content and 20 mg/ml hyaluronic acid. The MMG-23-04-2019 has been classified as a Class III medical device under Annex IX of Directive MDD 93/42 EEC since it is a long-term, invasive and absorbable medical device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MMG-23-04-2019 | The dermal filler MMG-23-04-2019 is applied to the female intimate area (intramucosal administration) of vaginal vestibule, vaginal walls, clitoris, "G" spot. |
Timeline
- Start date
- 2019-11-11
- Primary completion
- 2020-06-12
- Completion
- 2020-08-17
- First posted
- 2020-12-09
- Last updated
- 2020-12-09
Locations
1 site across 1 country: Bulgaria
Source: ClinicalTrials.gov record NCT04659668. Inclusion in this directory is not an endorsement.