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