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NCT05910294Recruiting

A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer

Randomized Pilot Prevention Trial to Improve Sexual and Vulvovaginal Health Concerns in Premenopausal Female Breast Cancer Patients Receiving Ovarian Suppression

Source: ClinicalTrials.gov · Last updated 1 Apr 2026

Brief summary (registry, in English)

Researchers are doing this study to look at whether sexual health counselling and using non-hormonal moisturizer at the start of ovarian suppression may be able to prevent or reduce side effects such as vaginal dryness and sexual dysfunction. Researchers will compare how effective this prevention intervention works compared to the usual approach, which is to treat these side effects after they start. All participants will also complete surveys about their sexual health. This information will help researchers learn more about the sexual health of women with breast cancer receiving ovarian suppression.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
1 Jun 2023
Start date
1 Jun 2023
Primary completion date
30 Jun 2027
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT05910294

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 1 Jun 2023 to the primary completion date, 30 Jun 2027
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients already using VVA treatment (e.g. intravaginal estrogen, other non-hormonal moisturizer or suppository), unless discontinued with washout of 4 weeks

Age

  • Postmenopausal women who have been without a period for ≥ 2 years

Other

  • Patients who score a 4 or above on the VAS and VuAS

Who the study is looking for

  • Women, 18 years of age or older
  • Breast cancer patients with hormone receptor positive breast cancer , stage 0-III
  • Premenopausal or perimenopausal women who have either been pregnant or had at least one menstrual period in the last 24 months or have/had an IUD in place
  • Patients currently on or are being initiated on ovarian suppression
  • Patients are asymptomatic for vaginal symptoms of estrogen deprivation (i.e. vaginal dryness, dyspareunia, or discomfort \[pain with intercourse or examination\]) and score a 3 or less on the VAS and VuAS

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesRecruiting
Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)
Coordinator of this site? Confirm its status
CommackUnited StatesRecruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Coordinator of this site? Confirm its status
HarrisonUnited StatesRecruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Coordinator of this site? Confirm its status
MiddletownUnited StatesRecruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Coordinator of this site? Confirm its status
MontvaleUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Coordinator of this site? Confirm its status
UniondaleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.