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.
This is a prospective, international, multicenter study performed in 2 steps: * From 0 to 12 weeks: randomized, single-blind, placebo-controlled study; * From 12 to 52 weeks: open label, treatment only study. The study will assess the efficacy of DESIRIAL® in reducing the vulvovaginal symptomatology after a single injection. One hundred twenty one 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 (2:1 ratio) receive a 1mL-injection of DESIRIAL® (Desirial Only group, DO) or placebo (Placebo and Desirial group, PAD) in the vestibular and vaginal mucosa using the multi-puncture and/or retrolinear technique at D0. If still eligible 12 weeks after, patients from PAD group receiving placebo at Day 0 will be treated with DESIRIAL®. Group DO will be followed up at 4, 12, 24, 36 and 52 weeks timepoints.Group PAD will be followed up at 4, 12, 16, 24, 36 and 48 weeks timepoints. Phone interview will be performed between 3 and 5 days after injection to check safety. Variation of vulvovaginal symptomatology, sexual function and vaginal pH will be measured using vulvovaginal symptomatology questionnaire, Female Sexual Function Index (FSFI) and vaginal pH indicator strip respectively. Safety will also be assessed through collection of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
121
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.
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.
Gynecology private office
Antwerp, Belgium
Cabinet Gynécologie Obstétrique
Liège, Belgium
Gynaecologisch Centrum
Mechelen, Belgium
Gynaecologie Dr Deniz Gulcan
Meise, Belgium
Cabinet Dr Ali Bennani
Wavre, Belgium
MIRHA
Zaventem, Belgium
Clinique Georges V
Bordeaux, France
CHRU Jeanne de Flandres
Lille, France
Cabinet de gynécologie
Marseille, France
Cabinet de Gynécologie
Paris, France
...and 4 more locations
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".
Time frame: 12 weeks after Day 0
Variation of most bothersome symptom (MBS)
Changes in mean severity score of MBS after a single injection of DESIRIAL® as detailed: * From baseline (V1) to 4 weeks after a single injection of DESIRIAL® in comparison to placebo (DO versus PAD group); * From baseline (Visit 1) to 4, 24, 36 and 52 weeks post-injection for patients in DO group; * From Visit 3 (12 weeks) to 16, 24, 36 and 48 weeks for patients in 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".
Time frame: 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
Changes in mean severity score of other moderate to severe symptoms after a single injection of DESIRIAL® as detailed: * From baseline (Visit 1) to 4 and 12 weeks after a single injection of DESIRIAL® in comparison to placebo (DO versus PAD group); * From baseline (Visit 1) to 4, 12, 24, 36 and 52 weeks post-injection for patients in DO group; * From Visit 3 (12 weeks) to 16, 24, 36 and 48 weeks for patients in 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".
Time frame: 4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0
Percentage of responders
Percentages of patients with a most bothersome symptom score less than or equal to 1 (mild) at week 12 in comparison to placebo (DO group versus PAD group)
Time frame: 12 weeks after Day 0
Variation of sexual function
Changes in Female Sexual Function Index (FSFI) scores after a single DESIRIAL® injection: * From baseline (Visit 1) to 4 and 12 weeks after a single injection of DESIRIAL® in comparison to a placebo (DO group versus PAD group); * From baseline (Visit 1) to 4, 12, 24, 36 and 52 weeks post-injection for patients in DO group; * From Visit 3 at 12 weeks to 16, 24, 36 and 48 weeks for patients in PAD group. FSFI consists in 19 questions with multiple-choice responses coded from 0.0 to 5.0. Each score has a specific meaning depending on the question. The scale has six sexual domains. The maximum score for each domain is 6.0, obtained by summing item responses and multiplying by a correction factor. The total composite sexual function score is a sum of domain scores and ranges from 2.0 (not sexually active and no desire) to 36.0.
Time frame: 4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0
Variation of vaginal pH
Changes in pH after a single DESIRIAL® injection: * From baseline (Visit 1) to 4 and 12 weeks after a single injection of DESIRIAL® in comparison to a placebo (DO group versus PAD group); * From baseline (Visit 1) to 4, 12, 24, 36 and 52 weeks post-injection for patients in DO group; * From Visit 3 (12 weeks) to 16, 24, 36 and 48 weeks for patients in PAD group.
Time frame: 4 weeks, 12 weeks, 16 weeks, 24 weeks, 36 weeks, 48 weeks and 52 weeks after Day 0
Report of adverse events
Evaluation of product tolerance by collection of adverse events
Time frame: Through study completion, up to 52 weeks for DO group and up to 48 weeks for PAD group
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