Clinical trial NCT01697345: Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy
Official title: Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: A Pilot Study on the Effects of Vaginal Testosterone Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Vaginal Dryness
Dyspareunia
Sexual Health Quality of Life
Keywords: Vaginal Testosterone
Vaginal atrophy
Female Sexual Dysfunction
Aromatase Inhibitors
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2012-10-02
Enrollment: 12
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Total Female Sexual Function Index (FSFI) Score
timeFrame: Baseline, 4 weeks
measure: FSFI Desire Domain
timeFrame: Baseline, 4 weeks
measure: FSFI Arousal Domain
timeFrame: Baseline, 4 weeks
measure: FSFI Lubrication Domain
timeFrame: Baseline, 4 weeks
measure: FSFI Orgasm Domain
timeFrame: Baseline, 4 weeks
measure: FSFI Satisfaction Domain
timeFrame: Baseline, 4 weeks
measure: FSFI Pain Domain
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study
timeFrame: After 4 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Nebraska Cancer Specialists/Midwest Cancer Center - Legacy
state: Nebraska
Study officials:
affiliation: Creighton University
name: Melissa A Dahir, DNP
role: PRINCIPAL_INVESTIGATOR
affiliation: Creighton University
name: Dianne Travers-Gustafson, PhD
role: STUDY_CHAIR
affiliation: Nebraska Cancer Specialists
name: Robert Langdon, MD
role: STUDY_DIRECTOR
References: