Vaginal Atrophy Clinical Trials
Here are the 2 most popular medical studies for vaginal atrophy
Progestogen
Vaginal Progesterone for Atrophic Vaginitis
Atrophic vaginitis affects the majority of post-menopausal women. It is characterized by dryness and inflammation of the vagina, with thinning of the vaginal tissues. Atrophic vaginitis is caused by the decreased effect of estrogens post menopause. Traditionally, local estrogens have been used to treat atrophic vaginitis Studies have shown that there are progesterone receptors in vaginal tissues. The use of progesterone to treat atrophic vaginitis has not yet been studied. However, its use has been studied in other populations including as a fertility medication in pregnant women. There is a significant group of women who cannot use, choose not to use, or do not respond to estrogenic therapies. The goal of this study is to evaluate the efficacy of vaginal progesterone in the treatment of urogenital atrophy, compared to placebo. This study is a randomized, double-blind, placebo controlled trial. The ultimate goal is to expand the treatment options for patients with symptoms of vaginal atrophy.
Fractional CO2 Laser
CO2RE for Vulvovaginal Atrophy
The CO2RE laser system is a fractional CO2 laser that is FDA approved under a 510(k) K101321 for dermatologic procedures requiring ablation and coagulation of soft tissues, including the skin Eligible subjects will undergo 3 treatments in 4±1 weeks interval on the Vagina (External/Vulva and Internal/Vagina) with the CO2RE device according to study protocol. Subject will return for to 5 follow-up (FU) visits: 1 week ± 2 days post first treatment visit and 1, 3, 6 and 12 months after last (third) treatment (± 2 weeks). Methodology described in protocol to evaluate efficacy of treatments will be carried out at each visit at the clinic.
Popular filter options for vaginal atrophy trials
Vulvovaginal Atrophy Clinical Trials
View 8 Vulvovaginal Atrophy medical studies.
Androgen
Intrarosa for Menopause
Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor all depend on androgens for normal function. In addition, the glands, which secrete lubrication during sexual arousal, also require androgens to function. Deficiencies of both estrogens and androgens occur naturally during menopause. Menopause-related deficiencies of these hormones lead to thinning in the tissues of the genital and urinary systems which have been termed Genitourinary Syndrome of Menopause (GSM). Patients with GSM will frequently complain of dryness and/or pain during sexual intercourse. Historically, GSM treatment involved both androgens and estrogens, However, over the past few decades estrogen based therapies have become much more common. More recently, clinical trials have demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in menopausal women who have moderate to severe pain with intercourse. Intrarosa® vaginal inserts are a prescription medicine approved by the U.S. Food and Drug Administration (FDA) used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause.
Fractional CO2 Laser
CO2 Laser Treatment for Vulvovaginal Atrophy
To assess the feasibility and efficacy of the CO2 fractional handpiece in the treatment of vulvovaginal atrophy (VVA) in post-menopausal women and its effect on the patient VHIS(vaginal health index core). The primary endpoint is to assess the change in the vaginal dryness by means of a visual analogic scale (10 cm VAS).
VVA Clinical Trials
View 8 VVA medical studies.
Androgen
Intrarosa for Menopause
Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor all depend on androgens for normal function. In addition, the glands, which secrete lubrication during sexual arousal, also require androgens to function. Deficiencies of both estrogens and androgens occur naturally during menopause. Menopause-related deficiencies of these hormones lead to thinning in the tissues of the genital and urinary systems which have been termed Genitourinary Syndrome of Menopause (GSM). Patients with GSM will frequently complain of dryness and/or pain during sexual intercourse. Historically, GSM treatment involved both androgens and estrogens, However, over the past few decades estrogen based therapies have become much more common. More recently, clinical trials have demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in menopausal women who have moderate to severe pain with intercourse. Intrarosa® vaginal inserts are a prescription medicine approved by the U.S. Food and Drug Administration (FDA) used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause.
Fractional CO2 Laser
CO2 Laser Treatment for Vulvovaginal Atrophy
To assess the feasibility and efficacy of the CO2 fractional handpiece in the treatment of vulvovaginal atrophy (VVA) in post-menopausal women and its effect on the patient VHIS(vaginal health index core). The primary endpoint is to assess the change in the vaginal dryness by means of a visual analogic scale (10 cm VAS).
Vaginal Atrophy Clinical Trials With No Placebo
View 10 vaginal atrophy medical studies that do not have a placebo group.
Fractional CO2 Laser
CO2 Laser Treatment for Vulvovaginal Atrophy
To assess the feasibility and efficacy of the CO2 fractional handpiece in the treatment of vulvovaginal atrophy (VVA) in post-menopausal women and its effect on the patient VHIS(vaginal health index core). The primary endpoint is to assess the change in the vaginal dryness by means of a visual analogic scale (10 cm VAS).
Frequently Asked Questions
Introduction to vaginal atrophy
What are the top hospitals conducting vaginal atrophy research?
When it comes to addressing the challenging condition of vaginal atrophy, several hospitals are actively engaged in groundbreaking clinical trials. Among them is Orange Coast Women's Medical Group in Laguna Hills, which currently has one active trial focused on this specific issue. Although their overall record boasts only two previous trials related to vaginal atrophy, the fact that they initiated their first trial as recently as 2022 demonstrates their commitment to advancing research and treatment options for patients. In Sarasota, Site 117 is also conducting an ongoing clinical trial for vaginal atrophy, showcasing a dedication to finding innovative solutions for this condition. Similarly, Site 113 in Norcross and Site 104 in Wichita are each undertaking one active trial aimed at improving outcomes for individuals experiencing vaginal atrophy. These locations may have yet to contribute historically significant findings regarding the condition but signify a promising shift towards understanding and treating this often-overlooked aspect of women's health. Lastly, located in Birmingham is Site 10112 where significant efforts towards addressing vaginal atrophy are being made through an active clinical trial; while no historical records exist thus far from this site’s involvement with this particular ailment,it indicates a growing recognition of the importance of researching viable treatments.
These hospitals' participation shines light on an often neglected area within women's healthcare – providing hope that advancements will be made not just in raising awareness but also developing effective interventions for those affected by vaginal atrophy. By investing resources into these trials and pushing boundaries within medical science,collaborations among various institutions nationwide aim to improve quality of life experiences and offer fresh perspectives on managing this widely prevalent condition faced by many women worldwide
Which are the best cities for vaginal atrophy clinical trials?
When it comes to vaginal atrophy clinical trials, several cities are actively conducting research in this field. Norcross, Georgia; Wichita, Kansas; Birmingham, Alabama; Sacramento, California; and Miami Lakes, Floridaam, Alabama; Sacramento, California; and Miami Lakes, Florida are all hosting two active trials each. These studies primarily focus on the effectiveness of Estradiol vaginal inserts with a dosage of 4 mcg as well as other potential treatment options. With multiple locations across different states participating in these trials, individuals experiencing vaginal atrophy have access to various research opportunities that aim to improve their well-being and quality of life.
Which are the top treatments for vaginal atrophy being explored in clinical trials?
Vaginal atrophy, a condition affecting many women, is currently being addressed in clinical trials with the exploration of two top treatments. Estradiol, introduced in 2016 and now involved in one active trial dedicated to vaginal atrophy, shows promising potential. Equally noteworthy is the estradiol vaginal insert which made its debut in 2020 and has also garnered attention through one ongoing trial specifically focused on this condition. With further research and development, these treatments may offer much-needed relief for individuals experiencing vaginal atrophy.
What are the most recent clinical trials for vaginal atrophy?
The field of vaginal atrophy research has witnessed several recent clinical trials, offering hope for those affected by this condition. One such trial focused on the efficacy of estradiol in treating vaginal atrophy and reached Phase 4, making it a significant milestone in advancing our understanding of this treatment option. Additionally, another study examined the use of estradiol vaginal inserts specifically designed to alleviate symptoms associated with vaginal atrophy. By narrowing down potential treatments through rigorous testing and evaluation, these trials provide valuable insights into managing and improving outcomes for individuals battling vaginal atrophy.
What vaginal atrophy clinical trials were recently completed?
Several recent clinical trials have made significant strides in addressing vaginal atrophy, a common condition affecting many women. One notable study, sponsored by the University of California, recently completed its investigation into the effectiveness of an innovative treatment method. Another trial conducted by the National Institute for Health Research explored a different approach to managing this condition and reached completion not long ago. These advancements showcase the dedication of researchers in their mission to improve treatments for vaginal atrophy and provide hope for those experiencing its symptoms.