GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors (GSM)

July 23, 2018 updated by: Uma Suryadevara, Alta Bates Summit Medical Center
The impact of treatment for GSM on the quality of life will be examined for postmenopausal women (defined as last menstrual period > 1 year ago or 6 months ago with FSH >40) who have been diagnosed with breast cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Postmenopausal breast cancer survivors who report at least one GSM sign or symptom will be offered participation in an observational, prospective open label trial. Study duration will be 6 months.

Evidence of GSM symptoms will be evaluated by a board certified gynecologist. Upon satisfying the prescreen requirements, the patient's information will be forwarded to the sub-investigator, who will confirm study eligibility and make the final determination verifying the diagnosis of GSM. Participants will be using commercially available Replens applied via prefilled applicator into the vagina and coconut oil applied at the vaginal introitus and vulva. Both are to be administered by the patient 2 times per week, interval between dosing to be approximately 2 days. Patients will be encouraged to apply Preseed, coconut oil, or patient's personal lubricant of choice into the vagina prior to sexual activity. Patients will record dosing on the Intake Diary. Outcome measures will include:

Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire will be administered at Baseline, at month 1, 3 and month 6. The FSFI (Female Sexual Function Index) questionnaire will also be used for sexually active patients at the same time points. This is an exploratory investigation. A planned paired T test will be applied to analyze the outcome and regroup after data has been collected on the first 14 patients.

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Early Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female
  2. Postmenopausal women (defined as last menstrual period > 1 year ago or 6 months ago with FSH >40) who have been diagnosed with breast cancer including in situ carcinoma (DCIS, LCIS)
  3. Have self-identified GSM signs and objective symptoms on baseline screening
  4. Patients already using Replens™ or coconut oil will have a two week washout period prior to starting study treatment.
  5. Medical History review and Pelvic Exam by a board certified gynecologist for baseline assessment OR medical records review by a board certified gynecologist or delegated study staff to confirm diagnosis of GSM. If GSM is to be verified by medical record review, the sub-investigator will make the final determination of eligibility.

Exclusion Criteria:

  1. Use of any estrogen containing product within 4 weeks prior to screening
  2. Endometrial hyperplasia, endometrial cancer, or other gynecologic malignancy
  3. Patients with non GSM related signs and symptoms as verified by a board certified gynecologist will be excluded.
  4. Any concurrent illness or disorder that, per the opinion of the investigator, would preclude the patient from meeting the study requirements.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Replens and coconut oil
Commercially available Replens applied via prefilled applicator into the vagina and coconut oil applied at the vaginal introitus and vulva. Both are to be administered by the patient 2 times per week, interval between dosing to be approximately 2 days. Patients will be encouraged to apply Preseed, coconut oil, or patient's personal lubricant of choice into the vagina prior to sexual activity.
Combination product: Replens and coconut oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of GSM signs and/or symptoms
Time Frame: 1 month
To show improvement of GSM signs and/or symptoms at month 1 compared to baseline period of administration of the study intervention. This will be measured by administering the Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire.
1 month
Improvement of GSM signs and/or symptoms
Time Frame: 3 months
To show improvement of GSM signs and/or symptoms at month 3 compared to baseline period of administration of the study intervention. This will be measured by administering the Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire.
3 months
Improvement of GSM signs and/or symptoms
Time Frame: 6 months
To show improvement of GSM signs and/or symptoms at month 6 compared to baseline period of administration of the study intervention. This will be measured by administering the Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual health of breast cancer survivors who are sexually active who are enrolled in this study
Time Frame: 6 months
This study will investigate the sexual health of breast cancer survivors who are sexually active and using Replens™, Preseed™, coconut oil, or the patient's personal lubricant of choice prior to intercourse by the FSFI (Female Sexual Function Index) questionnaire. The percent change, from baseline to 6 months, in painful sexual activity will be explored.
6 months

Collaborators and Investigators

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

Sponsor

Alta Bates Summit Medical Center

Investigators

  • Principal Investigator: Uma Suryadevara, MD, Alta Bates Summit Medical 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.

General Publications

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)

November 18, 2016

Primary Completion (Actual)

July 23, 2018

Study Completion (Actual)

July 23, 2018

Study Registration Dates

First Submitted

May 26, 2017

First Submitted That Met QC Criteria

June 9, 2017

First Posted (Actual)

June 14, 2017

Study Record Updates

Last Update Posted (Actual)

July 26, 2018

Last Update Submitted That Met QC Criteria

July 23, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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