Early Phase 1
N=13
Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy
Breast Cancer · Vaginal Dryness · Dyspareunia · Sexual Health Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT01697345 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Total Female Sexual Function Index (FSFI) Score — 8.691; 18.783 units on a scale — p=<0.0005
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Testosterone (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- Creighton University
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Female Sexual Function Index (FSFI) Score |
8.691; 18.783 | <0.0005 sig |
| PRIMARY FSFI Desire Domain |
1.350; 2.650 | <0.0005 sig |
| PRIMARY FSFI Arousal Domain |
1.200; 2.825 | 0.002 sig |
| PRIMARY FSFI Lubrication Domain |
1.175; 2.675 | 0.018 sig |
| PRIMARY FSFI Orgasm Domain |
1.733; 2.933 | 0.005 sig |
| PRIMARY FSFI Satisfaction Domain |
2.300; 4.200 | 0.001 sig |
| PRIMARY FSFI Pain Domain |
0.933; 3.500 | <0.0005 sig |
| SECONDARY Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study |
11; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT01697345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.