Autologous Platelet Concentrate Combined to Hyaluronic Acid Obtained With Cellular Matrix® BCT-HA… (NCT02966925) | Clinical Trial Compass
CompletedNot Applicable
Autologous Platelet Concentrate Combined to Hyaluronic Acid Obtained With Cellular Matrix® BCT-HA Kit and Vulvovaginal Dryness
France20 participantsStarted 2016-03
Plain-language summary
Vulvovaginal irritation is a frequent complaint among postmenopausal women. Common symptoms of vaginal atrophy include dryness, itching, burning and dyspareunia.
This pilot study will assess the efficacy of platelet-rich plasma (PRP) combined to hyaluronic acid (HA) to relieve vulvovaginal dryness in patients who cannot benefit from reference treatments (hormonal therapies).To achieve this, 20 patients suffering from vulvovaginal dryness will be treated with one session of injections in the vulva, the posterior vaginal wall and the perineum, and followed-up for 6 months. Improvement of vaginal dryness will be primarily appreciated through Friedmann score and pH value, and secondarily through the Female Sexual Function Index (FSFI), as measured at baseline and 1, 3 and 6 months after the treatment.
Who can participate
Age range
40 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:
* Patients suffering from vulvovaginal dryness who cannot benefit from hormonal therapy
* Patients having signed an Informed Consent
* Patient capable of understanding the study's imperatives
Exclusion Criteria:
* Vulvovaginal inflammation or infection
* History of vaginal herpes
* History of vulvar, vaginal or cervical cancer
* Lichen sclerosus
* History of allergy to HA
* Hereditary or acquired hematological or clotting disorders, such as drepanocytosis, platelet dysfunction, thrombocytopenia (150'000 platelets/µl)
* Anemia (HGB ≤ 10g/dl)
* Autoimmune disease (Hashimoto, rheumatoid disease, lupus, etc.)
* HIV positive
* Hepatitis B or C
* Pregnancy or breastfeeding
* No contraception
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.