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

March 26, 2026 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

50 premenopausal or perimenopausal women who are receiving ovarian suppression as part of their breast cancer treatment will be randomized to upfront intervention vs at the time of symptom development (standard of care). Patients will have subjective and objective monitoring of vaginal dryness and sexual dysfunction.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Jeanne Carter, PhD
  • Phone Number: 646-888-5076

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
        • Contact:
          • Shari Goldfarb, MD
          • Phone Number: 646-888-5080
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
        • Contact:
          • Shari Goldfarb, MD
          • Phone Number: 646-888-5080
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
        • Contact:
          • Shari Goldfarb, MD
          • Phone Number: 646-888-5080
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)
        • Contact:
          • Shari Goldfarb, MD
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
        • Contact:
          • Shari Goldfarb, MD
          • Phone Number: 646-888-5080
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Shari Goldfarb, MD
          • Phone Number: 646-888-5080
        • Principal Investigator:
          • Shari Goldfarb, MD
        • Contact:
          • Jeanne Carter, PhD
          • Phone Number: 646-888-5076
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
        • Contact:
          • Shari Goldfarb, MD
          • Phone Number: 646-888-5080

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
Other: moisturizers
potential vaginal moisturizers include Hyalogyn, Replens, Liquibeads, or Vitamin E capsules
Other: 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
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.
Other: 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.
Other: moisturizers
potential vaginal moisturizers include Hyalogyn, Replens, Liquibeads, or Vitamin E capsules
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with a score of 4 or greater in VAS
Time Frame: 1 year
measured by the Vaginal Assessment Scale (VAS)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shari Goldfarb, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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