Clinical Trial: Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen
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 vaginal dryness. Women who have had breast cancer are usually told not to take estrogen. This is because estrogen use can lead to a breast cancer recurrence or a new primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise in your estrogen level. However, there is no clear evidence that this would cause any bad effects in patients with breast cancer. How much, if any, of these topical estrogens are absorbed through the vagina is not known. We also do not know what the impact is of low dose estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as the mucus membranes are restored after estrogen exposure.
Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center
Current Primary Outcome: 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. [ Time Frame: 2 years ]
Original Primary Outcome: 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 25 µg 17- β estradiol. [ Time Frame: 2 years ]
Current Secondary Outcome:
- To compare the rise in estradiol in women on letrozole vs. anastrozole during treatment with low dose vaginal 10 µg 17- β estradiol to see if there are differences between aromatase inhibitors. [ Time Frame: 2 years ]
- To describe patterns of estradiol and FSH levels over the twenty-four week study period. [ Time Frame: 24 weeks ]
- To compare the patient's Female Sexual Function Index (FSFI) scores and menopause quality of life questionnaire at baseline, week 12 and week 24. [ Time Frame: Week 12 and week 24 ]
Original Secondary Outcome:
- To compare the rise in estradiol in women on letrozole vs. anastrozole during treatment with low dose vaginal 25 µg 17- β estradiol to see if there are differences between aromatase inhibitors. [ Time Frame: 2 years ]
- To describe patterns of estradiol and FSH levels over the twenty-four week study period. [ Time Frame: 24 weeks ]
- To compare the patient's Female Sexual Function Index (FSFI) scores at baseline, week 12 and week 24. [ Time Frame: Week 12 and week 24 ]
Information By: Memorial Sloan Kettering Cancer Center
Dates:
Date Received: September 24, 2009
Date Started: September 2009
Date Completion: September 2018
Last Updated: May 31, 2017
Last Verified: May 2017
