Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy

NCT ID: NCT01697345

Last Updated: 2014-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-05-31

Brief Summary

It is well documented that women who have breast cancer may experience a decrease in quality of life and sexual functioning due to side effects from adjuvant endocrine therapy, typically aromatase inhibitors (AIs). Women taking AIs are more likely to report unpleasant urogenital and vaginal symptoms due to the physiologic suppression of estradiol. This treatment can impair sexual functioning and cause a decreased sexual health quality of life.

At the present time, there are no Food and Drug Administration (FDA) approved medications for the vulvovaginal or sexual side effects related to the use of AIs. The lack of treatment options is concerning because the number of women diagnosed with breast cancer continues to increase; their longevity, also, continues to increase with the use of newer adjuvant chemotherapies. Local health care practitioners have observed that the benefits of vaginal testosterone for sexual health in breast cancer survivors are similar to the benefits of vaginal estrogen in women without breast cancer.

The purpose of this study is to evaluate the impact of using a daily compounded vaginal testosterone cream for 4 weeks (28 days) on breast cancer survivor's reported experience of vulvovaginal symptoms accompanying the use of AIs and their associated quality of life and sexual functioning.

Conditions

Breast Cancer; Vaginal Dryness; Dyspareunia; Sexual Health Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vaginal Testosterone

Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).

Group Type: EXPERIMENTAL

Testosterone

Intervention Type: DRUG

Interventions

Testosterone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Women with breast cancer
• Currently taking an aromatase inhibitor (AI)
• Age > 50 years of age
• Postmenopausal, or two years since last menstrual cycle
• Urogenital/vulvovaginal symptoms such as vaginal dryness and pain with intercourse
• Changes in sexual health quality of life/sexual functioning since starting AI therapy

Exclusion Criteria

• The use of other treatments for breast cancer such as chemotherapy or radiation within the past 12 months
• A known sensitivity to medications containing testosterone
• The use of exogenous hormone replacement therapy (HRT) in the past three months, including systemic and local estrogen or testosterone therapy

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Creighton University

OTHER

Sponsor Role: lead

Responsible Party

Melissa Dahir

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melissa A Dahir, DNP

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Dianne Travers-Gustafson, PhD

Role: STUDY_CHAIR

Creighton University

Robert Langdon, MD

Role: STUDY_DIRECTOR

Nebraska Cancer Specialists

Locations

Nebraska Cancer Specialists/Midwest Cancer Center - Legacy

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

MelissaDahir

Identifier Type: -

Identifier Source: org_study_id