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New treatment option for Vulvar Atrophy
Official title Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.
ClinicalTrials.gov ID: NCT06962345
What this study is testing
- What it's testing
- The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the vulvovaginal area. Symptoms of vaginal atrophy will be compared before and after 8 weeks of use of the tested gel with the Day-to-Day Impact of Vaginal Aging (DIVA) PROMs questionnaire to assess changes impact of GSM symptoms.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70, women only
You may be able to join if
- Patient has to have at least one symptom of GSM or suffer from symptoms related to vulvovaginal atrophy (as evidenced by gynecological examination...
- Patient must be postmenopausal with at least 1 year without a menstrual period.
- Patient must consider that her quality of life is affected by GSM symptoms
- Patient not followed due to any gynecological disease.
- All participants must be able to understand and to fill in the self-reported questionnaires.
You likely can't join if
- Patients that do not want to fill the questionnaire, especially the questions that address sexual functioning.
- Participants that use any oral products containing hormones or estrogen receptor modulators for the past 8 weeks, nor vaginal topical hormone...
- Patients with history of vulvar, vaginal and/or cervical malignancy.
- Patients having received radiotherapy treatment in the pelvic and/or genital region.
- Patients with any type of disease that causes alteration of collagenogenesis.
- Patients that use cytotoxic drugs leading to mucositis and alterations of tissue regeneration in the last 6 months.
See the full eligibility criteria
- Patient has to have at least one symptom of GSM or suffer from symptoms related to vulvovaginal atrophy (as evidenced by gynecological examination with a Vaginal Health Index ≤15).
- Patient must be postmenopausal with at least 1 year without a menstrual period.
- Patient must consider that her quality of life is affected by GSM symptoms
- Patient not followed due to any gynecological disease.
- All participants must be able to understand and to fill in the self-reported questionnaires.
- Patients that do not want to fill the questionnaire, especially the questions that address sexual functioning.
- Participants that use any oral products containing hormones or estrogen receptor modulators for the past 8 weeks, nor vaginal topical hormone products within 4 weeks, neither prescription nor non-prescription therapies...
- Patients with history of vulvar, vaginal and/or cervical malignancy.
- Patients having received radiotherapy treatment in the pelvic and/or genital region.
- Patients with any type of disease that causes alteration of collagenogenesis.
- Patients that use cytotoxic drugs leading to mucositis and alterations of tissue regeneration in the last 6 months.
- Patients having received laser and/or radiofrequency treatment for handling genital atrophy or other pelvic floor dysfunctions.
- Patients with active urinary and/or genital tract infection.
- Patients with history of malignant neoplasm of the urinary system.
- Patients with severe stress urinary incontinence (Sandvik test score equal to or greater than 8).
- Patients with diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification.
- Patients with medical or surgery history that, at the investigator's discretion, does not allow participation in the study.
- Patients with any other condition that, at the investigator's discretion, implies that the patient is unable to understand the implication of participating in the study and/or following the established procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. 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.