Infections

All Conditions

Symptoms and General Pathology

Wounds and Injuries

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Communicable Diseases

Vaginitis

Precancerous Conditions

Vulvar Diseases

Vulvovaginitis

Vaginal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida

vaginitis panel

Rachel Lacy

Primary:

* To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision
* To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease We will use a vulvovaginal swab to test for the most common causes of vulvovaginitis - bacterial vaginosis (BV), trichomonas, and candida. The swab will be collected preoperatively on day of surgery. The outcome will be evaluated by phone call to patient at 1 week after surgery and physical exam at the postoperative visit between 4-6 weeks.

Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions

To measure the rate of perioperative vulvovaginitis in a population of patients in central VA with non-malignant vulvar disease who require surgical excision

To correlate the rate of vulvovaginitis with rate of wound cellulitis and incisional breakdown in patients undergoing SPV/WLE for vulvar disease

University of Virginia

Principal Investigator

Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients

Efficacy of Placebo in preventing vaginitis in oncologic patients

Adelmidrol vaginal gel

Placebo vaginal gel

Fabio Ghezzi, MD

We hypothesise that the use of Adelmidrol (Saginil in vaginal cannulas) can reduce the incidence and magnitude of vaginitis in patients affected by gynecologic malignancies.

Saginil in vs. Placebo for Gynecologic Oncology Patients Affected by Vaginitis

Saginil in Vaginal Cannulas vs. Placebo for the Prevention of Vaginitis in Gynecologic Oncologic Patients Receiving Chemotherapy: a Randomized Controlled Trial.

Università degli Studi dell'Insubria

Professor

Skin and Connective Tissue Diseases

Behaviors and Mental Disorders

Breast Neoplasms

Atrophy

Dyspareunia

Atrophic Vaginitis

Breast Diseases

Skin Diseases

Genital Diseases, Male

Sexual Dysfunction, Physiological

Male Urogenital Diseases

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Antineoplastic Agents

All Drugs and Chemicals

Dermatologic Agents

Methyltestosterone

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Aromatase Inhibitors

Emollients

Androgens

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Anabolic Androgenic Steroids

Anabolic Agents

Daily application of vaginal testosterone for 28 days.

Testosterone USP micronized powder at a dose of 1mg/gr will be made into a paste with polysorbate 80 NF liquid and will be placed in an emollient cream base. A calibrated applicator will be supplied to measure out doses containing 300mcg of testosterone for daily application. The cream will be applied daily for 28 days. As above if safety and efficacy endpoints are met at this dose a lower dose (150mcg) will be used and if in tun this meets safety and efficacy endpoints a lower dose (75mcg) will be used.

Testosterone propionate

Sabrina M Witherby, MD

Hyman Muss, MD

Marie Wood, MD

Atrophic vaginitis is a condition in which the skin lining of the vagina and labia becomes thin and symptoms develop including vaginal itching, vaginal discomfort and dyspareunia. These can significantly affect women's comfort, sexuality and quality of life.

Treatment for this condition includes estrogen given in pill form, commonly known as hormone replacement therapy and local estrogen treatments, such as vaginal estrogen creams and topical vaginal lubricants. Unfortunately, systemic estrogen is contraindicated in many women with breast cancer. Some providers also feel that women who are taking aromatase inhibitors for their breast cancer should also not use local estrogens as several small studies suggest that these treatments might effect estrogen levels and thus might change how effective the aromatase inhibitors are. If these women choose not to use any form of estrogen therapy there symptoms may not be well controlled with other treatments.

The investigators hypothesize that a vaginal testosterone cream might be a safe and effective alternative treatment for these women. This small study is intended to test the hypothesis that testosterone cream will not increase estrogen (estradiol) levels and that it will improve the symptoms of atrophic vaginitis including vaginal dryness, vaginal itching and pain with intercourse.

The investigators will enroll women in the trial who are taking an aromatase inhibitor and have the symptoms mentioned above. They will receive a testosterone cream which will be applied vaginally once a day for 28 days. If good results are found with a prespecified dose of testosterone, a lower dose will be tested in the next group of women enrolled.

Atrophic vaginitis is a condition in which the skin lining of the vagina and labia becomes thin, usually due to a decreased estrogen state - such as menopause. Symptoms of atrophic vaginitis include vaginal itching, vaginal discomfort and dyspareunia and can significantly affect women's comfort, sexuality and quality of life.

Treatment for this condition includes estrogen given in pill form, commonly known as hormone replacement therapy and local estrogen treatments, such as vaginal estrogen creams and topical vaginal lubricants. Unfortunately, systemic estrogen is contraindicated in many women with breast cancer. Some providers also feel that women who are taking aromatase inhibitors for their breast cancer should also not use local estrogens as several small studies suggest that these treatments might effect estrogen levels and thus might change how effective the aromatase inhibitors are. If these women choose not to use any form of estrogen therapy there symptoms may not be well controlled with other treatments.

The investigators hypothesize that a vaginal testosterone cream might be a safe and effective alternative treatment for these women. This small study is intended to test the hypothesis that testosterone cream will not increase estrogen (estradiol) levels and that it will improve the symptoms of atrophic vaginitis including vaginal dryness, vaginal itching and pain with intercourse.

The investigators will enroll women in the trial who are taking an aromatase inhibitor and have the symptoms mentioned above. They will receive a testosterone cream which will be applied vaginally once a day for 28 days. If good results are found with a prespecified dose of testosterone, a lower dose will be tested in the next group of women enrolled.

Objectives:

PRIMARY OBJECTIVE:

1.1. Does topical testosterone cream affect serum estradiol levels in women taking aromatase inhibitors for breast cancer?

SECONDARY OBJECTIVES:

1.2. Can atrophic vaginitis and resultant symptoms of vaginal dryness, itching and dyspareunia in women taking aromatase inhibitors for the treatment of breast cancer be improved with a topical testosterone cream?

1.3. Does topical testosterone cream affect physical findings, pH and cytologic changes in atrophic vaginitis?

Schema:

Intervention - Subjects will apply a testosterone cream to the vaginal area daily for one month (28 days).

Evaluation - Before and after the study intervention participants will have testosterone and high-sensitivity estradiol tested. They will complete a questionnaire on symptoms of atrophic vaginitis and have a gynecologic examination (with visual, speculum, pH and sample of vaginal epithelial cells.)

Endpoints - Serum estradiol levels Improvement in symptoms of atrophic vaginitis, as measured by questionnaire. Atrophic vaginitis as measured by gynecological examination (including pH and cytology to assess maturation index).

Vaginal Testosterone Cream For Atrophic Vaginitis in Women Taking Aromatase Inhibitors for Breast Cancer.

Will evaluate if serum estradiol levels, measured with a high sensitivity assay, increase in women taking aromatase inhibitors for breast cancer after study intervention of 28 days of vaginal testosterone treatment.

Will evaluate if symptoms of atrophic vaginitis measured on a symptoms questionnaire impove in women taking aromatase inhibitors for breast cancer after study intervention of 28 days of vaginal testosterone treatment.

Will evaluate if clinical signs of vaginal atrophy on gynecologic examination decrease in women taking aromatase inhibitors for breast cancer after study intervention of 28 days of vaginal testosterone treatment.

Will evaluate if pathologic measures of atrophic vaginitis including maturation index and vaginal pH change in women on aromatase inhibitos for breast cancer after study intervention of 28 days of vaginal testosterone treatment.

University of Vermont

Reproductive Control Agents

Estradiol

Letrozole

Estrogens

Follicle Stimulating Hormone

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Polyestradiol phosphate

Anastrozole

Contraceptive Agents

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

This is a prospective longitudinal pilot study, and the targeted patient population is postmenopausal women with breast cancer being treated with adjuvant aromatase inhibitors who are initiated on vaginal 17β-estradiol to relieve symptoms of atrophic vaginitis.

The goal is to have 30 patients on letrozole and 30 on anastrozole who are initiated on vaginal estrogen for symptoms of urogenital atrophy. All subjects will receive 10mcg vaginal 17-β estradiol tablets. Each subject will serve as her own control. We will monitor serum estradiol and follicle stimulating hormone (FSH) levels closely from 0-24 weeks. We will measure serum estradiol and FSH levels at baseline, and subsequently at weeks 2, 7, 12, 18 and 24 after commencing therapy with 10mcg vaginal 17-β estradiol.

Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist

Shari Goldfarb, MD

The purpose of this study is to see if Vagifem® 10mcg is safe for women who have had breast cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina. It relieves vaginal dryness. Women who have had breast cancer are usually told not to take estrogen. This is because estrogen use can lead to a breast cancer recurrence or a new primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise in your estrogen level. However, there is no clear evidence that this would cause any bad effects in patients with breast cancer. How much, if any, of these topical estrogens are absorbed through the vagina is not known. We also do not know what the impact is of low dose estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as the mucus membranes are restored after estrogen exposure.

Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Evaluation of Infectious Vulvovaginitis on Wound Complication Rates After Vulvar Excision for Premalignant Lesions	NCT06070454	Vaginitis Vulvar Diseases	vaginitis panel	18 Years -	University of Virginia
Saginil in vs. Placebo for Gynecologic Oncology Patients Affected by Vaginitis	NCT01420510	Vaginitis	Adelmidrol vagi... Placebo vaginal...	-	Università degli Studi dell'Insubria
Vaginal Testosterone Cream For Atrophic Vaginitis in Women Taking Aromatase Inhibitors for Breast Cancer.	NCT01122342	Vaginitis Dyspareunia Breast Neoplasm...	Testosterone pr...	18 Years -	University of Vermont
Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen	NCT00984399	Atrophic Vagini... Breast Cancer	Vagifem® (vagin...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for vaginitis

Every month we try and update this database with for vaginitis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vaginitis

Every month we try and update this database with for vaginitis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vaginitis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.