GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors
Stopped early · Early Phase 1
Conditions studied: Genitourinary Abnormality, Breast Cancer Female, Vaginal Abnormality, Urinary Tract Infections, Dyspareunia, Dysuria
In brief
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.
Key facts
- Study ID
- NCT03185169
- Run by
- Alta Bates Summit Medical Center
- People needed
- 14
- Starts
- 2016-11-18
- Expected to finish
- 2018-07-23
- Last updated by the study team
- 2018-07-26
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Alta Bates Summit Medical Center — Berkeley, California, United States
Full record on ClinicalTrials.gov
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