Recruiting

Sexual Health

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05910294

Conditions

Improve Sexual Health

Improve Vulvovaginal Health

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

questionnaires

moisturizers

moisturizers

Study Details

Brief summary:

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.

Conditions

Improve Sexual Health

Improve Vulvovaginal Health

Study ID

NCT05910294

Start date

Jun 1, 2023

Status verified date

Mar, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Postmenopausal women who have been without a period for ≥ 2 years
  • Patients who score a 4 or above on the VAS and VuAS
  • Patients already using VVA treatment (e.g. intravaginal estrogen, other non-hormonal moisturizer or suppository), unless discontinued with washout of 4 weeks

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: symptom onset

Symptom onset arm will receive treatment at the time symptoms develop. Patients will be provided a list of recommended moisturizers by the female sexual medicine and women's health program (FSMWHP), but will purchase the moisturizers themselves at their local pharmacy.

experimental: intervention

Patients who are randomized to the upfront arm will receive sexual health counseling and be initiated on non-hormonal moisturizers 3-5 times per week (based on data regarding need in our patient population) at the time ovarian suppression. The upfront intervention group will also be educated about dilators and have a consultation with a pelvic floor physical therapist. Some potential vaginal moisturizers include Hyalogyn, Replens, Liquibeads, or Vitamin E capsules.

Interventions

questionnaires

Vaginal Assessment Scale (VAS) \& Vulvar Assessment Scale (VuAS) Breast Clinical Care and Symptom Survey (BCCSS) Female Sexual Function Index (FSFI) Sexual Activity Questionnaire (SAQ) Female Sexual Distress Scale Revised (FSDS-R) Menopausal Symptom Check List (MSCL) Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF) Weekly Non-Hormonal Moisturizer Diary

moisturizers

Patients will be provided a list of recommended moisturizers by the female sexual medicine and women's health program (FSMWHP), but will purchase the moisturizers themselves at their local pharmacy.

moisturizers

potential vaginal moisturizers include Hyalogyn, Replens, Liquibeads, or Vitamin E capsules

Primary outcome measure

  • Number of participants with a score of 4 or greater in VAS [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Shari Goldfarb, MD

646-888-5080goldfars@mskcc.org

Jeanne Carter, PhD

646-888-5076

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Shari Goldfarb, MD

646-888-5080

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Shari Goldfarb, MD

646-888-5080

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Shari Goldfarb, MD

646-888-5080

Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Shari Goldfarb, MD

646-888-5080

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Shari Goldfarb, MD

646-888-5080

Jeanne Carter, PhD

646-888-5076

Principal Investigator:

Shari Goldfarb, MD

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Shari Goldfarb, MD

646-888-5080

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • Sexual Health Concerns
  • Prevention
  • Premenopausal
  • Female Breast Cancer Patients
  • Receiving Ovarian Suppression
  • 23-109

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-04-01.