Trial of Vaginal Estrogen for Urogenital Symptom Relief in Women on Aromatase Inhibitors

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

Vagifem, is the most appropriate medication to treat bladder and vaginal symptoms such as vaginal dryness and urinary discomfort. The purpose of this research study is to see the benefit this three month vaginal estrogen tablet, Vagifem, has on the bladder, vaginal symptoms and health. The investigators also want to monitor whether the bones might be impacted by estrogen or its absence. If there is an effect on bones, it means that some estrogen may be absorbed from the tablet to affect other places in the body. The investigators are hoping to prove this is not the case. The investigators will also be measuring the quality of life of women participating in the study.

Key facts

Study ID

NCT02528383

Run by

Susan Tannenbaum

People needed

3

Starts

2015-08-01

Expected to finish

2017-05-01

Last updated by the study team

2017-09-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Treatment of Urogenital symptoms with Vagifem, as deemed appropriate by the treating physician
• History of breast cancer stages 0-III
• Currently being treated with Aromatase Inhibitors (brand not restrictive) for 3 months or longer
• Postmenopausal women including those with medically induced menopause
• Urogenital symptoms consistent with vaginal atrophy.
• Age 18 years or greater
• Able to participate in informed consent process
• Able to read/speak English
• Able to take daily doses of Vitamin D and Calcium

You may not qualify if…

• Abnormal or unexplained uterine bleeding
• Unable to give informed consent

Where it is running

• UConn Health — Farmington, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.