Ongoing Clinical Trials for Genitourinary Syndrome of Menopause
Two clinical trials are currently investigating treatment options for genitourinary syndrome of menopause, a condition affecting postmenopausal women that causes vaginal, vulvar, and urinary symptoms. These studies are testing different therapeutic approaches including hormonal treatments and regenerative therapies to help improve quality of life for women experiencing these menopausal symptoms.
Clinical trial locations
- Italy
- Spain
Study on the Effect of Prasterone on Genitourinary Syndrome in Postmenopausal Women with a History of Breast Cancer or Undergoing Anti-Hormonal Therapy
This trial, taking place in Italy, is investigating the use of Intrarosa, a vaginal pessary containing prasterone, for women experiencing genitourinary symptoms who have a history of breast cancer or are currently receiving anti-hormonal therapy. The study is expected to conclude by July 2026.
Who can participate: Women must be postmenopausal (whether naturally, surgically, or due to treatment) and have had breast cancer that was completely removed (stages I to III). Participants should have moderate to severe genitourinary symptoms that affect their quality of life, with a vaginal health index score below 15. They must show clinical signs of vulvovaginal atrophy during a gynecological examination and have normal kidney and liver function. A negative Pap smear test within one year before joining is required, and women should be sexually active or wish to be.
Who cannot participate: Women who are not postmenopausal, those without a history of breast cancer or not receiving estrogen-lowering treatment, and women without bothersome genitourinary symptoms cannot join. Men and vulnerable populations are also excluded.
Treatment approach: The study uses prasterone, which is administered intravaginally as a pessary. Prasterone works by converting into active sex hormones in the body, helping to restore vaginal tissue function and structure. This treatment aims to alleviate symptoms such as vaginal dryness, burning, irritation, and discomfort during intercourse.
What the trial measures: Researchers will monitor subjective improvement of genitourinary symptoms through regular gynecological evaluations, vaginal health assessments, and analysis of vaginal cytology. Serum estradiol levels will be measured throughout the treatment period to track hormonal changes. The study also evaluates how symptoms affect quality of life, including sexual function and mood.
Study on the Effectiveness of Platelet-Rich Plasma and Hyaluronic Acid vs. Estriol for Women with Menopausal Genitourinary Syndrome
This Spanish trial compares two different treatment approaches for genitourinary syndrome of menopause. The study evaluates whether a combination of platelet-rich plasma and hyaluronic acid is more effective than traditional local estrogen therapy.
Who can participate: Women who are postmenopausal (no menstrual period for at least 12 months), aged 70 or younger, and sexually active can join. Participants must have symptoms and signs of genitourinary syndrome with a vaginal health index score below 15 points. They must be able to understand Spanish and be willing to provide informed consent.
Who cannot participate: Women without genitourinary symptoms, men, and individuals considered part of vulnerable populations are excluded from the study.
Treatment approaches: Participants are randomly assigned to one of two treatment groups. The first group receives Cellular Matrix-BCT-HA, a combination of autologous platelet-rich plasma (made from the patient’s own blood) and non-cross-linked hyaluronic acid, administered through injection. This regenerative therapy aims to promote tissue repair and hydration. The second group uses Blissel, a vaginal gel containing estriol (a form of estrogen) that is applied locally to restore hormonal balance and improve vaginal health.
What the trial measures: Follow-up assessments occur at 3 months and 6 months after treatment begins. Researchers evaluate the vaginal health index, vulvar health index, vaginal pH, and vaginal maturation index. The intensity of specific symptoms including vaginal burning, itching, dryness, pain during intercourse, and urination discomfort is measured using a visual analog scale. The study’s primary goal is to determine the percentage of participants with improved symptoms, defined as a higher vaginal health index score compared to baseline measurements.
Summary
These two clinical trials offer different therapeutic options for women experiencing genitourinary syndrome of menopause. The Italian trial specifically focuses on women with a history of breast cancer, addressing an important gap in treatment options for this population who may have limited choices due to concerns about hormone therapy. The Spanish study takes a comparative approach, evaluating whether regenerative medicine techniques using platelet-rich plasma and hyaluronic acid can match or exceed the effectiveness of traditional estrogen therapy.
Both studies emphasize the importance of objective measurements such as the vaginal health index and systematic symptom tracking to evaluate treatment effectiveness. While the trials are conducted in different European countries and use distinct treatment approaches, they share the common goal of improving quality of life for postmenopausal women experiencing bothersome genitourinary symptoms. The Italian trial’s focus on women with breast cancer history represents a particularly important research area, as this population often experiences more severe symptoms due to anti-hormonal treatments but may have limited treatment options.
