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Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule (INREG 1)

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ClinicalTrials.gov Identifier: NCT02739880
Recruitment Status : Active, not recruiting
First Posted : April 15, 2016
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Laboratoires Vivacy
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment Phase
Menopause Dyspareunia Device: DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The study population

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.

Other Names:
  • Cross-linked Hyaluronic Acid
  • DESIRIAL®




Primary Outcome Measures :
  1. The thickness of the vaginal mucosa on a histological section [ Time Frame: Day 0 ]
  2. The thickness of the vaginal mucosa on a histological section [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Vaginal pH [ Time Frame: Day 0 ]
  2. Vaginal pH [ Time Frame: Week 8 ]
  3. Vaginal flora (on Pap smear) [ Time Frame: Day 0 ]
  4. Vaginal flora (on Pap smear) [ Time Frame: Week 8 ]
  5. Nugent score (on Pap smear) [ Time Frame: Day 0 ]
  6. Nugent score (on Pap smear) [ Time Frame: Week 8 ]
  7. PGI-I (Patient Global Impression and Improvement) Questionnaire [ Time Frame: Week 8 ]
  8. The Vaginal Health Index by Gloria Bachman [ Time Frame: Day 0 ]
  9. The Vaginal Health Index by Gloria Bachman [ Time Frame: Week 8 ]
  10. Pain (dyspareunia) by visual analog scale [ Time Frame: Day 0 ]
  11. Pain (dyspareunia) by visual analog scale [ Time Frame: Week 8 ]
  12. Measurement of collagen expression (procollagen I and III) [ Time Frame: Day 0 ]
  13. Measurement of collagen expression (procollagen I and III) [ Time Frame: Week 8 ]
  14. Level of Ki67 proliferation marker [ Time Frame: Day 0 ]
  15. Level of Ki67 proliferation marker [ Time Frame: Week 8 ]


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739880


Locations
France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Centre Médical KARIS
Perpignan, France, 66000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Laboratoires Vivacy
Investigators
Study Director: Nicolas Berreni, MD Centre Médical Karis

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02739880     History of Changes
Other Study ID Numbers: LOCAL/2016/PM-001
2016-A00124-47 ( Other Identifier: RCB number )
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Vaginal discomfort
Vaginal dryness

Additional relevant MeSH terms:
Dyspareunia
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Mental Disorders
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents