Efficacy and Safety of Hyaluronic Acid Injection on Symptoms of Vulvovaginal Atrophy in Postmenopausal Women

NCT04219722 | Completed

• 1 other identifier: 2019-A00034-53
• Study Type: interventional
• Target: 121
• Locations: 2 countries
• Sites: 14

Brief Summary

DESIRIAL® is a CE-marketed hyaluronic acid gel intented to rehydrate vaginal and vestibular mucous membranes by mucosal injections. In this study, 121 postmenopausal women of minimum age 45 with symptoms associated with vulvovaginal atrophy, refusing estrogen therapies for treatment of symptoms or with contraindications for such therapies, with at least one moderate to severe vulvovaginal symptom among dryness sensation, dyspareunia, itching / irritation and pain, who have given her informed consent and met all the eligibility criteria, will be enrolled. Patients will randomly receive 1 injection of DESIRIAL® or placebo (ratio 2:1) in the vaginal mucosa at Day 0. If still eligible 12 weeks after, patients receiving placebo at Day 0 will be treated with DESIRIAL®. Patients will come to a total of 6 to 8 visits depending on the product injected at Day 0 over a period of 11 up to 12 months. Phone interview will be performed between 3 and 5 days after injection. Variation of vulvovaginal symptomatology, sexual function, vaginal pH and safety will be assessed.

Conditions

Vulvovaginal Atrophy

Keywords

Vaginal dryness; Vulvovaginal symptoms; Hyaluronic acid; Injection; Postmenopause; Prospective; 2-step study; Single-blind; Randomized; Placebo; Open study

Outcome Measures

Primary Outcomes (1)

• Variation of most bothersome symptom

  Changes in mean Most Bothersome Symptom (MBS) severity score from baseline (Visit 1) to 12 weeks after a single injection of DESIRIAL® in comparison to a placebo (DO group versus PAD group). Symptom intensity is assessed using a 4-score scale (from 0 to 3) with minimum score representing a better outcome. Score 0 corresponds to "None", score 1 to "Mild", score 2 to "Moderate" and score 3 to "Severe".

  12 weeks after Day 0

Secondary Outcomes (6)

• Variation of most bothersome symptom (MBS)

  4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0

• Variation of other moderate to severe symptoms

  4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0

• Percentage of responders

  12 weeks after Day 0

• Variation of sexual function

  4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0

• Variation of vaginal pH

  4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0

Study Arms (2)

Desirial only group

ACTIVE COMPARATOR

Administration of DESIRIAL® at Day 0 (Visit 1)

Device: Injection of DESIRIAL®

Placebo and Desirial group

PLACEBO COMPARATOR

Administration of placebo at Day 0 (Visit 1). If still eligible 12 weeks (Visit 3) after placebo injection, patient will be treated with DESIRIAL®

Device: Injection of DESIRIAL®; Other: Injection of placebo

Interventions

Injection of DESIRIAL® DEVICE

DESIRIAL® is a hyaluronic acid injectable gel intended to treat symptoms associated with vulvovaginal atrophy in postmenopausal women by vaginal mucosa rehydration in this study. 1 mL of DESIRIAL® will be injected in the vestibule and on the posterior and lateral walls of the vagina, 2 to 3 cm after the introitus.

Also known as: Injection of hyaluronic acid gel

Desirial only group; Placebo and Desirial group

Injection of placebo OTHER

Placebo is an isotonic saline solution (0.9% NaCl). 1 mL of placebo will be injected in the vestibule and on the posterior and lateral walls of the vagina, 2 to 3 cm after the introitus.

Also known as: Injection of NaCl 0.9%

Placebo and Desirial group

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Refusing estrogen therapies for treatment of vulvovaginal symptomatology or with contraindications for such therapies;
• With at least one of the following vulvovaginal symptoms, as moderate to severe, self-assessed: Dryness sensation, Dyspareunia, Itching / irritation, Pain. Possible scores are 0 - none, 1 - mild, 2 - moderate, 3 - severe;
• Subject affiliated to a health social security system (if applicable according to national regulation);
• Informed consent signed by the patient for study enrolment.

You may not qualify if:

• Women with the following conditions:
• General:
• Pregnancy;
• Breast feeding;
• With a known tendency to develop hypertrophic or keloid scars;
• Participating at the same time in another clinical trial;
• Deprived of their freedom by administrative or legal decision or under trusteeship/guardianship;
• With a known and documented hypernatremia;
• With a known and documented hyperchloremia;
• With a severe case of hydric inflation and hydro-sodic retention, particularly in case of decompensated heart failure, decompensated liver failure (cirrhosis with oedema and ascites), and pre-eclampsia / eclampsia.
• Linked to genital status: With a stage 2 upper genital tract prolapse indicated for surgery.
• Linked to inflammatory or immune status:
• With a known hypersensitivity to one of DESIRIAL®'s components (hyaluronic acid, mannitol), to the antiseptic solution, to amide local anesthetics or to one of the components of anesthesia products planned to be used;
• Presence of clinical signs of inflammation in or close to the area of interest or treatment for these affections;
• History of or ongoing autoimmune disease.

Sponsors & Collaborators

• Laboratoires Vivacy: lead

Study Sites (14)

Gynecology private office

Antwerp, 2018, Belgium

Location

Cabinet Gynécologie Obstétrique

Liège, 4000, Belgium

Location

Gynaecologisch Centrum

Mechelen, 2800, Belgium

Location

Gynaecologie Dr Deniz Gulcan

Meise, 1860, Belgium

Location

Cabinet Dr Ali Bennani

Wavre, 1300, Belgium

Location

MIRHA

Zaventem, 1930, Belgium

Location

Clinique Georges V

Bordeaux, 33300, France

Location

CHRU Jeanne de Flandres

Lille, 59037, France

Location

Cabinet de gynécologie

Marseille, 13008, France

Location

Cabinet de Gynécologie

Paris, 75016, France

Location

Cabinet de gynécologie

Perpignan, 66000, France

Location

Polyclinique de l'Atlantique

Saint-Herblain, 44800, France

Location

Cabinet de Gynécologie

Tarnos, 40220, France

Location

Cabinet de gynécologie

Toulouse, 31000, France

Location

Related Publications (2)

• Bensmail H, Marchand Lamiraud F, Martin C, Pelckmans S, Cha'ban F, Siboni Frisch A, Deniz G, Sabban Serfati P, Caubo B, Gurriet B, Petit Breuilh I, Pastijn AI, Berreni N, Cosson M. Hyaluronic acid injection to treat symptoms of vulvovaginal atrophy and improve sexual function in postmenopausal women: A 52-week long-term follow-up. Maturitas. 2025 Oct;201:108687. doi: 10.1016/j.maturitas.2025.108687. Epub 2025 Aug 5.

  PMID: 40773978 DERIVED

• Marchand Lamiraud F, Bensmail H, Martin C, Pelckmans S, Cha'ban F, Siboni Frisch A, Deniz G, Sabban Serfati P, Caubo B, Gurriet B, Petit Breuilh I, Pastijn AI, Berreni N, Cosson M. Hyaluronic acid injection to treat symptoms of vulvovaginal atrophy in postmenopausal women: A 12-week randomised, placebo-controlled, multicentric study. Maturitas. 2025 Jun;197:108264. doi: 10.1016/j.maturitas.2025.108264. Epub 2025 Apr 12.

  PMID: 40273666 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded during the first 12 weeks of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study performed in two steps: * From 0 to 12 weeks: randomized, single-blind, placebo-controlled study * From 12 to 52 weeks: open label, treatment only study

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: January 7, 2020
• Study Start: January 21, 2020
• Primary Completion: September 29, 2021
• Study Completion: June 18, 2022
• Last Updated: April 10, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (6); FR (8)