Status:
COMPLETED
Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Atrophic Vaginitis
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to see if Vagifem® 10mcg is safe for women who have had breast cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina. It relieves va...
Eligibility Criteria
Inclusion
- History of breast cancer, stages I-III with pathology confirmed at MSKCC
- Women who have completed all of their primary treatment (surgery, radiation therapy, adjuvant chemotherapy) with the exception of endocrine therapy and currently have no clinical evidence of disease.
- Women who are currently on aromatase inhibitors for at least three months--either letrozole or anastrozole
- Women with symptomatic urogenital atrophy: vaginal dryness, irritation, pruritus, dyspareunia, urinary frequency and/or urinary incontinence
- Menopausal at study entry defined as:
- Bilateral salpingo-oophorectomy independent of age
- If natural menopause, age ≥ 50 with cessation of menses for at least 12 months
- If menopause induced by chemotherapy, age ≥ 50 with no menstrual period at least 12 months after chemotherapy finished
- At least 18 years of age
- Able to participate in the informed consent process
- Gynecology examination within six months
- Able to read/speak English
Exclusion
- Inability to give informed consent
- Vaginal bleeding of unknown etiology within 12 months of study entry
- History of prior vaginal 17-β estradiol or other topical estrogen use within the past six months
Key Trial Info
Start Date :
September 22 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2024
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00984399
Start Date
September 22 2009
End Date
May 13 2024
Last Update
December 9 2025
Active Locations (5)
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1
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
2
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
3
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
4
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States