Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule (INREG 1)
Primary Purpose
Menopause, Dyspareunia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)
Sponsored by
About this trial
This is an interventional treatment trial for Menopause focused on measuring Vaginal discomfort, Vaginal dryness
Eligibility Criteria
Inclusion Criteria:
- The patient must have given her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 8 weeks of follow-up
- The patient is menopausal (amenorrhea) for over 2 years and less than 10 years
- The patient has a body mass index <35
- The patient has sexual disorders (dyspareunia) or vaginal discomfort associated with vaginal dryness.
Exclusion Criteria:
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant or breastfeeding
- The patient is not menopausal (both clinically and biologically)
- The patient has a body mass index > 35
- The patient has a genital prolapse higher than stage 2 with a surgical indication
- The patient has stress incontinence with a surgical indication
- The patient suffers from vaginismus
- Presence of an untreated viral, fungal or bacterial vulvovaginal or urinary infection
- Hemorrhagic or neoplastic genital pathologies
- Existence of a hormone-dependent tumor, genital bleeding of unknown origin
- Current treatments based on antihypertensives, steroid anti-inflammatory drugs, anticoagulants, major antidepressants, aspirin
- Known hypersensitivity to hyaluronic acid or mannitol
- Known hypersensitivity to Betadine
- Known hypersensitivity to Lidocaine
- Hypersensitivity to EMLA®
- Previous urogynaecological vulvovaginal surgery
Sites / Locations
- CHRU de Nîmes - Hôpital Universitaire Carémeau
- Centre Médical KARIS
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The study population
Arm Description
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
Outcomes
Primary Outcome Measures
The thickness of the vaginal mucosa on a histological section
The thickness of the vaginal mucosa on a histological section
Secondary Outcome Measures
Vaginal pH
Vaginal pH
Vaginal flora (on Pap smear)
Vaginal flora (on Pap smear)
Nugent score (on Pap smear)
Nugent score (on Pap smear)
PGI-I (Patient Global Impression and Improvement) Questionnaire
The Vaginal Health Index by Gloria Bachman
The Vaginal Health Index by Gloria Bachman
Pain (dyspareunia) by visual analog scale
Pain (dyspareunia) by visual analog scale
Measurement of collagen expression (procollagen I and III)
Measurement of collagen expression (procollagen I and III)
Level of Ki67 proliferation marker
Level of Ki67 proliferation marker
Full Information
NCT ID
NCT02739880
First Posted
April 6, 2016
Last Updated
March 18, 2019
Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Laboratoires Vivacy
1. Study Identification
Unique Protocol Identification Number
NCT02739880
Brief Title
Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule
Acronym
INREG 1
Official Title
Evaluation of the Effect of Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule: A Prospective, Bicentric, Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
February 13, 2019 (Actual)
Study Completion Date
February 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Laboratoires Vivacy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Dyspareunia
Keywords
Vaginal discomfort, Vaginal dryness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The study population
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)
Other Intervention Name(s)
Cross-linked Hyaluronic Acid, DESIRIAL®
Intervention Description
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.
Primary Outcome Measure Information:
Title
The thickness of the vaginal mucosa on a histological section
Time Frame
Day 0
Title
The thickness of the vaginal mucosa on a histological section
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Vaginal pH
Time Frame
Day 0
Title
Vaginal pH
Time Frame
Week 8
Title
Vaginal flora (on Pap smear)
Time Frame
Day 0
Title
Vaginal flora (on Pap smear)
Time Frame
Week 8
Title
Nugent score (on Pap smear)
Time Frame
Day 0
Title
Nugent score (on Pap smear)
Time Frame
Week 8
Title
PGI-I (Patient Global Impression and Improvement) Questionnaire
Time Frame
Week 8
Title
The Vaginal Health Index by Gloria Bachman
Time Frame
Day 0
Title
The Vaginal Health Index by Gloria Bachman
Time Frame
Week 8
Title
Pain (dyspareunia) by visual analog scale
Time Frame
Day 0
Title
Pain (dyspareunia) by visual analog scale
Time Frame
Week 8
Title
Measurement of collagen expression (procollagen I and III)
Time Frame
Day 0
Title
Measurement of collagen expression (procollagen I and III)
Time Frame
Week 8
Title
Level of Ki67 proliferation marker
Time Frame
Day 0
Title
Level of Ki67 proliferation marker
Time Frame
Week 8
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient must have given her informed and signed consent
The patient must be insured or beneficiary of a health insurance plan
The patient is available for 8 weeks of follow-up
The patient is menopausal (amenorrhea) for over 2 years and less than 10 years
The patient has a body mass index <35
The patient has sexual disorders (dyspareunia) or vaginal discomfort associated with vaginal dryness.
Exclusion Criteria:
The patient is participating in another study
The patient is in an exclusion period determined by a previous study
The patient is under judicial protection, under tutorship or curatorship
The patient refuses to sign the consent
It is impossible to correctly inform the patient
The patient is pregnant or breastfeeding
The patient is not menopausal (both clinically and biologically)
The patient has a body mass index > 35
The patient has a genital prolapse higher than stage 2 with a surgical indication
The patient has stress incontinence with a surgical indication
The patient suffers from vaginismus
Presence of an untreated viral, fungal or bacterial vulvovaginal or urinary infection
Hemorrhagic or neoplastic genital pathologies
Existence of a hormone-dependent tumor, genital bleeding of unknown origin
Current treatments based on antihypertensives, steroid anti-inflammatory drugs, anticoagulants, major antidepressants, aspirin
Known hypersensitivity to hyaluronic acid or mannitol
Known hypersensitivity to Betadine
Known hypersensitivity to Lidocaine
Hypersensitivity to EMLA®
Previous urogynaecological vulvovaginal surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Berreni, MD
Organizational Affiliation
Centre Médical Karis
Official's Role
Study Director
Facility Information:
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France
Facility Name
Centre Médical KARIS
City
Perpignan
ZIP/Postal Code
66000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule
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