Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00124-47 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Laboratoires Vivacy | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The main objective of this study is to measure changes in the thickness of the vaginal lining (epithelium + underlying stroma) between 0 and 8 weeks after injection.
The secondary objectives of this study are to measure changes in the following between 0 and 8 weeks after injection:
A. vaginal flora and Nugent score.
B. vaginal pH.
C. functional evolution via the VHI index by Gloria Bachman (state of the vaginal mucosa), pain / dyspareunia (visual analog scale) and the satisfaction concerning care viay the PGI-I questionnaire (Patient Global Impression and Improvement).
D. Procollagen I and III gene expression (by PCR) and mitotic activity of the mucosa (Ki67 proliferation marker) based on biopsies.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study population | Experimental | The study population consists of postmenopausal patients (more than 2 years and less than 10 years) with a body mass index <35 with sexual disorders (dyspareunia) or vaginal discomfort associated with vaginal dryness. Intervention: Intra-mucosal Injections of Cross-linked Hyaluronic Acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid) | Device | Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule The intervention is Intended for intra-mucosal injection in women for biostimulation / rehydration of the surface layers of the lining of the genital areas, vaginal hypotrophies and / or treatment of female sexual dysfunction related to subsidence G "spot or area of Gräfenberg ". Following disinfection and topical anesthesia (lidocaine gel), the vesitbule is injected using a multi-point technique. The optimal volume of DESIRIAL® to be used for injection into the vestibule is approximately 0.3 ml in total. |
| Measure | Description | Time Frame |
|---|---|---|
| The thickness of the vaginal mucosa on a histological section | Day 0 | |
| The thickness of the vaginal mucosa on a histological section | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal pH | Day 0 | |
| Vaginal pH | Week 8 | |
| Vaginal flora (on Pap smear) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Berreni, MD | Centre Médical Karis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France | |||
| Centre Médical KARIS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34454465 | Result | Berreni N, Salerno J, Chevalier T, Alonso S, Mares P. Evaluation of the effect of multipoint intra-mucosal vaginal injection of a specific cross-linked hyaluronic acid for vulvovaginal atrophy: a prospective bi-centric pilot study. BMC Womens Health. 2021 Aug 28;21(1):322. doi: 10.1186/s12905-021-01435-w. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Day 0 |
| Vaginal flora (on Pap smear) | Week 8 |
| Nugent score (on Pap smear) | Day 0 |
| Nugent score (on Pap smear) | Week 8 |
| PGI-I (Patient Global Impression and Improvement) Questionnaire | Week 8 |
| The Vaginal Health Index by Gloria Bachman | Day 0 |
| The Vaginal Health Index by Gloria Bachman | Week 8 |
| Pain (dyspareunia) by visual analog scale | Day 0 |
| Pain (dyspareunia) by visual analog scale | Week 8 |
| Measurement of collagen expression (procollagen I and III) | Day 0 |
| Measurement of collagen expression (procollagen I and III) | Week 8 |
| Level of Ki67 proliferation marker | Day 0 |
| Level of Ki67 proliferation marker | Week 8 |
| Perpignan |
| 66000 |
| France |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |