Breast Cancer Clinical Trial
Official title:
Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: A Pilot Study on the Effects of Vaginal Testosterone Therapy
Verified date | December 2013 |
Source | Creighton University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | May 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Nebraska Cancer Specialists/Midwest Cancer Center - Legacy | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
Creighton University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Female Sexual Function Index (FSFI) Score | The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score < 26.5 suggests female sexual dysfunction. | Baseline, 4 weeks | No |
Primary | FSFI Desire Domain | The desire score is calculated by adding the individual scores from the desire domain (question #1 and #2) and multiplying the sum by the domain factor of 0.6. The domain score for desire ranges from 1.2 (minimum) to 6 (maximum) and a higher value represents a better outcome. | Baseline, 4 weeks | No |
Primary | FSFI Arousal Domain | The arousal score is calculated by adding the individual scores from the arousal domain (question #3, #4, #5, #6) and multiplying the sum by the domain factor of 0.3. The arousal domain score ranges from 0 (minimum) to 6 (maximum)and a higher value represents a better outcome. | Baseline, 4 weeks | No |
Primary | FSFI Lubrication Domain | The lubrication score is calculated by adding the individual scores from the lubrication domain (question #7, #8, #9, #10) and multiplying the sum by the domain factor of 0.3. The domain score for lubrication ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome. | Baseline, 4 weeks | No |
Primary | FSFI Orgasm Domain | The orgasm score is calculated by adding the individual scores from the orgasm domain (question #11, #12, #13) and multiplying the sum by the domain factor of 0.4. The domain score for orgasm ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome. | Baseline, 4 weeks | No |
Primary | FSFI Satisfaction Domain | The satisfaction score is calculated by adding the individual scores from the satisfaction domain (question #14, #15, #16) and multiplying the sum by the domain factor of 0.4. The satisfaction domain score ranges from 0.8 (minimum) to 6 (maximum) and a higher value represents a better outcome. | Baseline, 4 weeks | No |
Primary | FSFI Pain Domain | The score for pain is calculated by adding the individual scores from the pain domain (question #17, #18, #19) and multiplying the sum by the domain factor of 0.4. The domain score for pain ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome. | Baseline, 4 weeks | No |
Secondary | Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study | After 4 weeks | No |
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