Replens or Estradiol Vaginal Ring in Improving Vaginal Dryness in Stage I-III Estrogen Receptor-Positive Breast Cancer Survivors Receiving Aromatase Inhibitor Therapy

PRIMARY OBJECTIVES:

I. To compare improvement of vaginal dryness symptoms between women on the vaginal estrogen ring (estradiol vaginal ring) and those on Replens vaginal cream.

SECONDARY OBJECTIVES:

I. Assess compliance with aromatase inhibitor therapy in each arm to see whether vaginal estrogen therapy increases aromatase inhibitor (AI) compliance among women who have atrophic vaginitis.

II. Among subjects who are sexually active, assess sexual health of survivors by administering a questionnaire at baseline, 4 weeks, 12 weeks, and 24 weeks in both groups to see whether vaginal estrogen improves sexual health.

III. Using an ultra-sensitive estrogen assay, investigate the changes in serum estrogen levels in each arm over time.

IV. Evaluate vaginal dryness by a potentially more objective measure – vaginal pH.

TERTIARY OBJECTIVES:

I. To evaluate breast cancer recurrence in each arm over a 5 year time period.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive estradiol vaginal ring once every 3 months for 6 months.

ARM II: Patients receive Replens vaginal cream 3 times a week for 6 months.

After completion of study, patients are followed up every 6 months for 5 years.