Actively Recruiting
Combination of Vaginal CO2 Laser and Moisturizing Repairing Niosomal Gel for Treating Genitourinary Syndrome in Women with Cancer History
Led by Hospital Universitari de Bellvitge · Updated on 2024-07-29
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of vaginal CO2 laser treatment with a moisturizing and repairing niosomal gel for women who have genitourinary syndrome of menopause (GSM) and a history of cancer where hormone therapy is not recommended. This study aims to assess whether this combination is an effective and safe treatment option for these patients over a 12-month period. The study involves applying a CO2 vulvo-vaginal laser treatment along with moisturizing gels as part of the therapy. Participants are women diagnosed with GSM who have a history of neoplasia and cannot use estrogen-based treatments. This observational study does not involve randomization or placebo but focuses on monitoring the effects of this combined therapy. Participants will be followed and assessed over 12 months to evaluate the effectiveness, safety, and duration of the treatment benefits. Researchers will monitor patient outcomes related to GSM symptoms, treatment safety, and how long the benefits last. The total study period includes baseline evaluation and follow-up visits to collect data on these outcomes.
CONDITIONS
Brief Title
Combination of the Vaginal Laser With a Moisturizing and Repairing Niosomal Gel in the Treatment of Genitourinary Syndrome in Oncology Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with an established diagnosis of genitourinary syndrome of menopause.
- Patients with a history of cancer where estrogen treatment is not recommended for GSM.
You will not qualify if you...
- Patients with other vulvovaginal diseases.
- Patients diagnosed with pelvic organ prolapse grade II or higher.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants receive CO2 vulvo-vaginal laser treatment combined with moisturizing and repairing niosomal gel according to standard therapy.
Visits scheduled according to treatment and assessment plan
Trial Site Locations
Total: 1 location
1
Carlos
L'Hospitalet de Llobregat, Catalonia, Spain, 08907
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here