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

Information source: Creighton University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer; Vaginal Dryness; Dyspareunia; Sexual Health Quality of Life

Intervention: Testosterone (Drug)

Phase: Phase 0

Status: Completed

Sponsored by: Creighton University

Official(s) and/or principal investigator(s):
Melissa A Dahir, DNP, Principal Investigator, Affiliation: Creighton University
Dianne Travers-Gustafson, PhD, Study Chair, Affiliation: Creighton University
Robert Langdon, MD, Study Director, Affiliation: Nebraska Cancer Specialists


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.

Clinical Details

Official title: Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: A Pilot Study on the Effects of Vaginal Testosterone Therapy

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Total Female Sexual Function Index (FSFI) Score

FSFI Desire Domain

FSFI Arousal Domain

FSFI Lubrication Domain

FSFI Orgasm Domain

FSFI Satisfaction Domain

FSFI Pain Domain

Secondary outcome: Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study


Minimum age: 50 Years. Maximum age: N/A. Gender(s): Female.


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

Locations and Contacts

Nebraska Cancer Specialists/Midwest Cancer Center - Legacy, Omaha, Nebraska 68130, United States
Additional Information

Starting date: February 2013
Last updated: December 18, 2013

Page last updated: August 23, 2015

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