Efficacy of the Use of Cellular Matrix/ A-CP-HA Kit

Launched by FUNDACIÓN SANTIAGO DEXEUS FONT · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for women experiencing Genitourinary Syndrome of Menopause (GSM), a condition that can cause discomfort and a range of symptoms due to hormonal changes after menopause. The trial will include 192 sexually active women aged 25 to 70 who have a specific score indicating poor vaginal health. Participants will be randomly assigned to receive either the new treatment, which combines their own blood components with a natural substance called hyaluronic acid, or the standard treatment, which is a vaginal estrogen gel.

Throughout the study, participants will be monitored for 3 and 6 months after treatment to assess the effectiveness and safety of the treatments. This includes regular check-ins to evaluate their symptoms and overall vaginal health. Women who are interested in participating should be able to understand Spanish and be willing to commit to the study requirements. However, certain health conditions or recent treatments may exclude some women from participating. This trial is currently recruiting participants, and it aims to provide valuable information on a potentially effective alternative for managing GSM symptoms.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women ≤70 years old
• • Women that are sexually active
• • Women who report symptoms and signs of SGM, with a vaginal health index (VHIS - Bachmann score) \< 15 points.
• • Women who understand the Spanish language
• • Willing to participate in the study and sign informed consent.
• Exclusion Criteria:
• • Systemic or local hormonal treatment in the last 3 months
• • Tamoxifen or Aromatase inhibitor treatments
• • Vulvovaginal pathologies (condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, lichen sclerosus, lichen planus, history of radiation, history of cervical cancer, other gynecologic cancer, or pelvic radiation, or active genital infection (eg. g., bacterial vaginosis, genital herpes, candida) Contraindication for vaginal estrogen therapy
• • Women with thrombocytopenia or coagulation disorders, systemic infections, STDs, cancer of any type in recent treatment, connective tissue diseases.
• • Women who have had pelvic surgery within 6 months.
• • Women who are unwilling or unable to give informed consent and/or do not comply with the study requirements.