Actively Recruiting
Pilot Study to Prevent and Improve Sexual and Vaginal Health Issues in Premenopausal Women With Hormone Receptor Positive Breast Cancer Receiving Ovarian Suppression
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-01
50
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying sexual health and vulvovaginal health in premenopausal and perimenopausal women with hormone receptor positive breast cancer who are receiving ovarian suppression. The study aims to find out if starting sexual health counseling and using non-hormonal moisturizers early can prevent or reduce side effects like vaginal dryness and sexual dysfunction. This is compared to the usual care approach where treatment begins only after symptoms appear. Participants will be randomly assigned to one of two groups. One group will receive sexual health counseling and start using non-hormonal moisturizers 3 to 5 times weekly from the beginning of ovarian suppression, along with education about vaginal dilators and a consultation with a pelvic floor physical therapist. The other group will start treatment only after developing symptoms and will receive a list of recommended moisturizers to purchase themselves. Both groups will complete various questionnaires to monitor sexual health and vaginal symptoms. During the study, participants will be monitored through surveys and subjective and objective assessments of vaginal dryness and sexual function. Researchers will track the number of participants who have a score of 4 or higher on the Vaginal Assessment Scale within one year. The study includes regular completion of validated questionnaires and a weekly diary about moisturizer use. The total participation time corresponds with one year of follow-up to evaluate the interventions impact.
CONDITIONS
Brief Title
A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 18 years of age or older
- Hormone receptor positive breast cancer patients, stage 0-III
- Premenopausal or perimenopausal women who have been pregnant, had a menstrual period in the last 24 months, or have/had an IUD
- Currently on or starting ovarian suppression
- Asymptomatic for vaginal symptoms of estrogen deprivation and score 3 or less on VAS and VuAS
You will not qualify if you...
- Postmenopausal women without a period for 2 or more years
- Patients scoring 4 or above on VAS and VuAS
- Currently using vaginal atrophy treatments unless stopped with a 4-week washout
Research Team
S
Shari Goldfarb, MD
J
Jeanne Carter, PhD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here