Efficacy and Safety of Hyaluronic Acid Injection on Symptoms of Vulvovaginal Atrophy in Postmenop… (NCT04219722) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of Hyaluronic Acid Injection on Symptoms of Vulvovaginal Atrophy in Postmenopausal Women
Belgium, France121 participantsStarted 2020-01-21
Plain-language 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.
Who can participate
Age range
45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 45 years of age at inclusion;
* With postmenopausal status: at least 12 months of spontaneous amenorrhea or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy at the time of inclusion. Hormone-dependent breast cancer survivors previously treated with long-term anti-estrogen treatment tamoxifene, in complete remission of breast cancer, and with a post-menopause diagnosis after tamoxifene discontinuation are eligible;
* 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.
Exclusion Criteria:
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 ca…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.