An interventional study of DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid) in Menopause and Dyspareunia, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 2 sites in France. Open to female participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Treatment
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.
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's enrollment of 20 is below the median of 63 across 126 interventional studies indexed under Dyspareunia.
Browse Dyspareunia studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)
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.
Also known as: Cross-linked Hyaluronic Acid, DESIRIAL®
The thickness of the vaginal mucosa on a histological section
Time frame: Day 0
The thickness of the vaginal mucosa on a histological section
Time frame: Week 8
Vaginal pH
Time frame: Day 0
Vaginal pH
Time frame: Week 8
Vaginal flora (on Pap smear)
Time frame: Day 0
Vaginal flora (on Pap smear)
Time frame: Week 8
Nugent score (on Pap smear)
Time frame: Day 0
Nugent score (on Pap smear)
Time frame: Week 8
PGI-I (Patient Global Impression and Improvement) Questionnaire
Time frame: Week 8
The Vaginal Health Index by Gloria Bachman
Time frame: Day 0
The Vaginal Health Index by Gloria Bachman
Time frame: Week 8
Pain (dyspareunia) by visual analog scale
Time frame: Day 0
Pain (dyspareunia) by visual analog scale
Time frame: Week 8
Measurement of collagen expression (procollagen I and III)
Time frame: Day 0
Measurement of collagen expression (procollagen I and III)
Time frame: Week 8
Level of Ki67 proliferation marker
Time frame: Day 0
Level of Ki67 proliferation marker
Time frame: Week 8
Ran from Jun 2017 to primary completion in Sep 2018, 14 months.
Of 51 non-industry interventional studies with no phase under Dyspareunia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 14 months is below that.
Counting every sponsor, half of 59 studies reached it within 33 months; a quarter within 13 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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