Ongoing Clinical Trials for Atrophic Vulvovaginitis
There are currently 4 clinical trials investigating treatments for atrophic vulvovaginitis, also known as vulvovaginal atrophy. These studies are testing various hormonal treatments including vaginal rings, estrogen therapies, tamoxifen, and combination treatments with probiotics. The trials are being conducted across Europe, in Germany, Denmark, Sweden, and Belgium, and focus primarily on postmenopausal women experiencing vaginal dryness, discomfort, and related symptoms.
Clinical trial locations
- Belgium
- Denmark
- Germany
- Sweden
Study on Estriol Vaginal Ring for Treating Vaginal Atrophy in Postmenopausal Women
This trial is testing a newly developed vaginal ring that releases estriol, a form of estrogen, to treat vaginal atrophy in postmenopausal women. The study is being conducted in Germany.
Who can participate:
- Women aged 45 years or older
- Must be postmenopausal for at least 1 year with FSH levels of 40 IU/l or higher
- Vaginal Maturation Value should be 50% or less
- Vaginal pH greater than 5.0
- At least one symptom such as dryness, pain, burning, itching, discharge, painful urination, urinary incontinence, or painful intercourse rated at 65 or higher on the symptom scale
- Non-smokers or those who quit smoking at least 3 months ago
Who cannot participate:
- Male patients
- Those not experiencing vaginal atrophy
- Members of vulnerable populations
What the study involves: Participants will be randomly assigned to use one of four vaginal rings for 90 days. Three rings release different doses of estriol (1 microgram, 10 micrograms, or 20 micrograms per day), while one is a placebo ring with no active medication. Neither participants nor researchers will know which ring each person receives during the study. Regular assessments will monitor changes in vaginal tissue and pH levels. A subset of participants will also have blood tests to measure how much estriol enters the bloodstream.
Study medication: The Estriol Vaginal Ring releases estrogen directly into vaginal tissue, helping to restore thickness and elasticity to the vaginal lining and reduce symptoms of dryness and discomfort.
Study on the Effects of Vaginal Estrogen Treatment with Nomegestrol Acetate and Estradiol Hemihydrate on Blood Clotting in Postmenopausal Women with Vaginal Atrophy
This trial in Denmark is studying how local vaginal estrogen treatment affects blood clotting processes in postmenopausal women. The treatment combines nomegestrol acetate and estradiol hemihydrate.
Who can participate:
- Postmenopausal women aged 50 or older
- Experiencing symptoms of vulvovaginal atrophy
- Have an indication for standard treatment with vaginal estrogen 10 micrograms at least three times a week
- Can participate with or without a history of venous thromboembolism
Who cannot participate:
- Men
- Women who are not postmenopausal
- Members of vulnerable populations
What the study involves: After confirming eligibility, participants will receive vaginal estrogen treatment at a dose of 10 micrograms, applied at least three times weekly for three months. Throughout the study, researchers will monitor blood parameters related to clotting and the breakdown of blood clots to understand how the treatment affects these processes.
Study medication: Local Vaginal Estrogen is applied directly to the vaginal area as a cream, tablet, or ring. It works by binding to estrogen receptors in vaginal tissue, promoting growth and maintenance of the vaginal lining to relieve dryness, itching, and discomfort.
Study on Vaginal Tamoxifen for Improving Sexual Function in Women with Breast Cancer Experiencing Vulvovaginal Atrophy Symptoms
This Swedish study is evaluating vaginal tamoxifen for women with breast cancer who experience symptoms affecting their sexual function.
Who can participate:
- Sexually active postmenopausal women with breast cancer
- Currently receiving adjuvant antiestrogen treatment with aromatase inhibitors
- Postmenopausal status confirmed by at least 12 months without periods, surgical removal of both ovaries at least 6 weeks ago, or FSH levels greater than 40 mIU/mL
- Vaginal pH greater than 5.0
- 5% or fewer superficial cells in vaginal smear test
- Estradiol levels below 20 pmol/l
- At least one moderate to severe symptom identified as most bothersome on the FACT-B scale
- Normal or non-significant physical examination findings, blood pressure of 150/90 mm Hg or lower, normal gynecological examination, normal mammogram within 36 months, and endometrial thickness less than 4 mm
Who cannot participate:
- Those not experiencing vulvovaginal atrophy symptoms
- Men
- Those outside the specified age range
- Members of vulnerable populations
What the study involves: This is a 12-week double-blind study where participants are randomly assigned to receive either vaginal tamoxifen or a placebo. Throughout the study, participants complete questionnaires including the Endocrine Subscale-FACT-B, Female Sexual Function Index, and Female Sexual Distress Scale-revised to assess symptom changes and quality of life. Baseline and follow-up assessments include physical examinations, blood pressure measurements, laboratory tests, vaginal pH tests, and smear cytology.
Study medication: Tamoxifen is a selective estrogen receptor modulator that can block or activate estrogen receptors in different tissues. In this study, it is administered vaginally to reduce vulvovaginal atrophy symptoms and improve sexual function in women undergoing breast cancer treatment.
Comparison of estriol, prasterone and estriol with lactobacillus for vulvovaginal atrophy in breast cancer patients on endocrine therapy
This Belgian study compares three different vaginal treatments for women with breast cancer experiencing vaginal atrophy as a side effect of their cancer treatment.
Who can participate:
- Women diagnosed with breast cancer
- Currently receiving endocrine therapy with aromatase inhibitors or selective estrogen receptor modulators
- Postmenopausal, confirmed by no periods for 12 months, no periods for 6 months with FSH above 40 mIU/mL, surgical removal of both ovaries, or medically induced menopause using GnRH-analogues
- At least one vaginal symptom: painful intercourse, vaginal dryness, or vaginal irritation
- Adult women 18 years or older
Who cannot participate:
- Those with metastatic breast cancer
- Presence of vaginal infections or other active vaginal conditions needing treatment
- Use of vaginal treatments in the past 4 weeks
- History of severe allergic reactions to study medications
- Participation in another clinical trial within the last 30 days
- Pregnant, planning pregnancy, or breastfeeding
- Uncontrolled medical conditions
- Pelvic radiation therapy within the last 6 months
- Current use of medications that could interact with study treatments
- Unable to follow study procedures or attend visits
- History of other hormone-dependent tumors
- Significant abnormal findings during initial gynecological examination
What the study involves: This 12-week study randomly assigns participants to one of three vaginal treatments: Oekolp (containing estriol), Gynoflor (containing estriol and lactobacillus), or Intrarosa (containing prasterone 6.5 mg). Assessments occur at the start, at 6 weeks, and at 12 weeks. Each assessment includes completing EQ5D and FACT-ES questionnaires, blood samples to measure hormone levels, vaginal pH measurement, and examination of vaginal tissue samples.
Study medications: The trial compares three approved vaginal medications that work in different ways to improve vaginal health and reduce symptoms of dryness and discomfort in breast cancer patients receiving endocrine therapy.
Summary
All four trials focus on postmenopausal women experiencing vulvovaginal atrophy, with varying approaches to treatment. The studies are distributed across four European countries: Germany, Denmark, Sweden, and Belgium. Two trials specifically target women with breast cancer who are experiencing symptoms as a side effect of their cancer treatment, reflecting the significant need for safe treatment options in this population.
The trials test different forms of hormone-based treatments including estriol vaginal rings, local vaginal estrogen, tamoxifen, and combination therapies with probiotics. Treatment durations range from 12 weeks to 90 days, with all studies monitoring symptom improvement and safety parameters. The German study uniquely tests different dose levels of estriol, while the Danish trial focuses on understanding effects on blood clotting, an important safety consideration for hormone-based treatments.
Common inclusion criteria across trials include postmenopausal status, vaginal pH greater than 5.0, and presence of bothersome vaginal symptoms. The studies collectively aim to provide evidence for effective and safe treatment options for a condition that significantly affects quality of life in postmenopausal women.
