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Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen

18 Years
Open (Enrolling)
Atrophic Vaginitis, Breast Cancer

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Trial Information

Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen

Inclusion Criteria:

- 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 Criteria:

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

To determine the change in estradiol and follicle stimulating hormone (FSH) from baseline to twelve weeks in postmenopausal women receiving adjuvant aromatase inhibitors during treatment with low dose vaginal 10 µg 17- β estradiol.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Mercedes Castiel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2009

Completion Date:

September 2014

Related Keywords:

  • Atrophic Vaginitis
  • Breast Cancer
  • vaginitis
  • Postmenopausal
  • 17-β estradiol
  • 09-110
  • Breast Neoplasms
  • Vaginitis
  • Atrophy



Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memoral Sloan Kettering Cancer CenterBasking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725
Memoral Sloan Kettering Cancer Center@Phelps Memorial HospitalSleepy Hollow, New York  
Memorial Sloan-Kettering at Mercy Medical CenterRockville Centre, New York