TerminatedEarly Phase 1

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

Stopped: Study design change required protocol/ICF changes, deemed more appropriate to terminate study and apply knowledge gained to potential future study design

United States14 participantsStarted 2016-11-18

Plain-language 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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Female
✓. 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)
✓. Have self-identified GSM signs and objective symptoms on baseline screening
✓. Patients already using Replens™ or coconut oil will have a two week washout period prior to starting study treatment.
✓. 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

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

What they're measuring

Improvement of GSM signs and/or symptoms

Timeframe: 1 month

Improvement of GSM signs and/or symptoms

Timeframe: 3 months

Improvement of GSM signs and/or symptoms

Timeframe: 6 months

Trial details

NCT IDNCT03185169

SponsorAlta Bates Summit Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-23

View on ClinicalTrials.gov More Genitourinary Abnormality trials

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Female
✓. 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)
✓. Have self-identified GSM signs and objective symptoms on baseline screening
✓. Patients already using Replens™ or coconut oil will have a two week washout period prior to starting study treatment.
✓. 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

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