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

NCT02528383 | Completed

• 1 other identifier: 15-143-3
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Postmenopausal Women on Aromatase Inhibitors; Vagifem

Outcome Measures

Primary Outcomes (1)

• Changes in serum estrogen levels

  Changes in serum estrogen levels will be measured up to 12 weeks in post-menopausal women receiving adjuvant aromatase inhibitors during treatment with low dose vaginal estradiol 10 ug tablet, Vagifem.

  12 Weeks

Secondary Outcomes (1)

• Quality of Life

  12 Weeks

Study Arms (1)

Vagifem

EXPERIMENTAL

Postmenopausal women diagnosed with breast cancer, are currently on an anti-estrogen called an aromatase inhibitor and you have agreed to undergo treatment with Vagifem based on your physician's recommendation.

Behavioral: Vagifem

Interventions

Vagifem BEHAVIORAL

Women participating in the study will undergo clinical assessments, blood work and complete the quality of life questionnaire at baseline, 6 weeks and 12 weeks study time points. The following will be assessed: 1. Effect of low dose Vagifem, 10ug tablet on vaginal atrophy. 2. Effect of low dose Vagifem, 10ug tablet on sex hormones and bone health biomarkers. 3. Impact of treatment on quality of life

Vagifem

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Susan Tannenbaum: lead
• Connecticut Breast Health Initiative: collaborator

Study Sites (1)

UConn Health

Farmington, Connecticut, 06032, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Susan Tannenbaum, MD

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 19, 2015
• Study Start: August 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 18, 2017

Record last verified: 2017-09

Locations

US (1)