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

Early Phase 1

Terminated

• Conditions: Breast Cancer Female; Urinary Tract Infections; Dyspareunia; Dysuria; Genitourinary Abnormality; Vaginal Abnormality
• Interventions: Combination Product: Replens and coconut oil

• Registration Number: NCT03185169
• Lead Sponsor: Alta Bates Summit Medical Center

Brief Summary

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.

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 Timeline

• Study Start: 2016-11-18
• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-06-09
• Study First Posted: 2017-06-14
• Status Verified: 2018-07
• Primary Completion: 2018-07-23
• Study Completion: 2018-07-23
• Last Update Submitted: 2018-07-23
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Replens and coconut oil	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.

Primary Outcome Measures

Name	Time	Method
Improvement of GSM signs and/or symptoms	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.

Secondary Outcome Measures

Name	Time	Method
Sexual health of breast cancer survivors who are sexually active who are enrolled in this study	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.

Trial Locations

Locations (1)

Alta Bates Summit Medical Center; 🇺🇸 Berkeley, California, United States