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New treatment option for Vulvar Atrophy
Official title Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy
ClinicalTrials.gov ID: NCT07024667
What this study is testing
- What it's testing
- Vulvo Vaginal Atrophy (VVA) refers to the changes in the vaginal and vulvar surfaces that occurs during menopause due to the progressive loss of estrogen. The low levels of circulating estrogen produce a wide variety of anatomic, physiologic, and clinical changes in the urogenital area.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75, women only
You may be able to join if
- Female 45-75 years of age, at the time of enrolment.
- Provided written informed consent.
- Spontaneous induced menopause as defined by one of the followings:
- Amenorrhea of ≥12 months
- After bilateral oophorectomy
You likely can't join if
- Vaginal Health Index Score (VHIS) \< 5.
- Active genital infection.
- Vaginal bleeding which did not underwent evaluation.
- Previous vulvar, vaginal or cervical dysplasia, within the last 2 years, or previous cancer.
- Recurring urinary tract infection or recurring infection of genital herpes (≥ 3 episodes in the recent year).
- Pelvic Organ prolapse (POP) \>II, according to the pelvic organ prolapse quantification system (POP-Q).
See the full eligibility criteria
- Female 45-75 years of age, at the time of enrolment.
- Provided written informed consent.
- Spontaneous induced menopause as defined by one of the followings:
- Amenorrhea of ≥12 months
- After bilateral oophorectomy
- FSH levels\>30 IU
- One or more VVA related symptoms (i.e., itching, dryness, burning, pain, dyspareunia, or dysuria), after other possible causes of these complaints have been excluded.
- Characteristic atrophic changes (see above) on gynaecological examination.
- Normal Papanicolaou (PAP) smear test from the last 3-5 years: if needed and as indicated according to the Israeli guidelines.
- Negative urine analysis test - urine stick.
- Asymptomatic for bacterial or fungal vaginitis.
- Vaginal canal, introitus and vestibule free of injuries and bleeding.
- Able and willing to comply with the treatment/ follow-up schedule and requirements.
- Normal general gynecological exam from the last year including US.
- Vaginal Health Index Score (VHIS) \< 5.
- Active genital infection.
- Vaginal bleeding which did not underwent evaluation.
- Previous vulvar, vaginal or cervical dysplasia, within the last 2 years, or previous cancer.
- Recurring urinary tract infection or recurring infection of genital herpes (≥ 3 episodes in the recent year).
- Pelvic Organ prolapse (POP) \>II, according to the pelvic organ prolapse quantification system (POP-Q).
- Serious systemic disease or any chronic condition that could interfere with study compliance.
- Any local, systemic and/or chronic autoimmune infection.
- Taken part in a clinical trial concerning VVA, within 30 days prior to the enrolment.
- Allergy to lidocaine or tetracaine.
- Genital skin disease that may interfere with the treatment (these people should be included/excluded according to the investigator's discretion).
- Use of anticoagulants, within 5 days prior to enrolment.
- Active positive HPV test.
- Active positive HSV (Acute or actively present within the last 2 months).
- Heavy smoker (\>1 pack of cigarettes a day)
- Any disease or medication that may interfere with the wound healing/immune function.
- Pregnancy / breast feeding.
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
The study team makes the final eligibility decision.
Where it's taking place
- Hadera, Israel
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, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hadera, Israel. 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.