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New treatment option for Vulvo Vaginal Atrophy
Official title Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment
ClinicalTrials.gov ID: NCT06828640
What this study is testing
- What it's testing
- This is a randomized, controlled trial aiming to evaluate the effectiveness of adding vaginal dilators to the treatment of vulvovaginal atrophy. Study Population: Peri- and postmenopausal women with VVA, including breast cancer survivors.
- 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 18 to 85, women only
You may be able to join if
- Peri- or postmenopausal women suffering from vulvovaginal atrophy (VVA)
- Breast cancer survivors with VVA symptoms
- Understand the study, be willing to participate, and sign an informed consent form.
- The use of estrogen/progestogen-based products (vaginal, oral, pellets, transdermal, etc.) is permitted but must be documented (this will be...
You likely can't join if
- Undiagnosed abnormal genital bleeding.
- Administration of any investigational drug within 30 days prior to the screening visit.
- Presence of a serious medical condition, neurological disorder, or significant comorbidities.
- Other gynecological malignancies.
- Recent vaginal surgery.
- Clinically significant prolapse (POP-Q ≤ 2).
See the full eligibility criteria
- Peri- or postmenopausal women suffering from vulvovaginal atrophy (VVA)
- Breast cancer survivors with VVA symptoms
- Understand the study, be willing to participate, and sign an informed consent form.
- The use of estrogen/progestogen-based products (vaginal, oral, pellets, transdermal, etc.) is permitted but must be documented (this will be considered during randomization).
- Undiagnosed abnormal genital bleeding.
- Administration of any investigational drug within 30 days prior to the screening visit.
- Presence of a serious medical condition, neurological disorder, or significant comorbidities.
- Other gynecological malignancies.
- Recent vaginal surgery.
- Clinically significant prolapse (POP-Q ≤ 2).
- Current urinary tract or vaginal infection, or recent sexually transmitted infection.
- Individuals with disabilities unable to communicate.
- Women eligible for the study but unwilling to participate.
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Brussels Capital, Belgium
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, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Brussels Capital, Belgium. 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.