Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+1 MoreVagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing whether the Vagifem® 10mcg product is safe for women who have had breast cancer.

Eligible Conditions
  • Breast Cancer
  • Atrophic Vaginitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 2 years

2 years
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.
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.
24 weeks
To describe patterns of estradiol and FSH levels over the twenty-four week study period.
Week 24
To compare the patient's Female Sexual Function Index (FSFI) scores and menopause quality of life questionnaire at baseline, week 12 and week 24.

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

vaginal 17β-estradiol, questionnaire , symptom checklist
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist · No Placebo Group · N/A

vaginal 17β-estradiol, questionnaire , symptom checklist
Drug
Experimental Group · 1 Intervention: Vagifem® (vaginal 17β-estradiol) questionnaire & menopause symptom checklist · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,483 Total Patients Enrolled
192 Trials studying Breast Cancer
93,739 Patients Enrolled for Breast Cancer
Shari Goldfarb, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
1,324 Total Patients Enrolled
6 Trials studying Breast Cancer
1,324 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a history of breast cancer, stages I-III with pathology confirmed at MSKCC.
You have had bilateral salpingo-oophorectomy independent of age.
You are at least 18 years old.
You are able to consent to medical treatment.\n
You are a woman who has completed all of her primary treatment (surgery, radiation therapy, adjuvant chemotherapy) with the exception of endocrine therapy and currently have no clinical evidence of disease.