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Tests treatment safety and results for Vaginal Dryness
Official title Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients
ClinicalTrials.gov ID: NCT06900374
What this study is testing
- What it's testing
- This Phase III, randomized, balanced, parallel-group, multicenter trial aims to evaluate the effect of vaginal radiofrequency on symptoms of vaginal dryness at six months. The study compares vaginal radiofrequency treatment with non-hormonal hydration therapy in a population of patients undergoing adjuvant hormonal therapy with aromatase inhibitors, with or without LHRH agonists, for breast cancer.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, women only
You may be able to join if
- Patient over 40 years
- Presenting disabling vaginal dryness symptoms despite well-administered local moisturizing treatment, attested by a vaginal dryness score ≥3
- Patient undergoing adjuvant treatment for breast cancer
- Patient treated with aromatase inhibitors +/- LHRH agonist for at least 3 months with a planned remaining duration of at least 12 months
- Patient affiliated to a social security organization
You likely can't join if
- Contraindications related to the radiofrequency technique:
- Ongoing urinary tract infection
- Pacemaker
- IUD intrauterine device
- Pregnancy
- Mucocutaneous disease with vulvovaginal localization: infection, sore, scleratrophic lichen, psoriasis, eczema, etc.
See the full eligibility criteria
- Patient over 40 years
- Presenting disabling vaginal dryness symptoms despite well-administered local moisturizing treatment, attested by a vaginal dryness score ≥3
- Patient undergoing adjuvant treatment for breast cancer
- Patient treated with aromatase inhibitors +/- LHRH agonist for at least 3 months with a planned remaining duration of at least 12 months
- Patient affiliated to a social security organization
- Patient having signed the informed consent for the present study
- Contraindications related to the radiofrequency technique:
- Ongoing urinary tract infection
- Pacemaker
- IUD intrauterine device
- Pregnancy
- Mucocutaneous disease with vulvovaginal localization: infection, sore, scleratrophic lichen, psoriasis, eczema, etc.
- Neurodegenerative disease with perineal involvement
- Current or recent treatment (within the last 12 months) with other physical methods: vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection or lipo-modeling.
- Pregnant or breast-feeding women
- Patients under guardianship or trusteeship.
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.