Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy
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Purpose
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. As mentioned, vaginal testosterone is not FDA approved for women. Vaginal testosterone is available to women by prescription through compounding pharmacies.
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.
The investigator will enroll postmenopausal women greater than 50 years of age taking AI therapy with reported symptoms of vaginal dryness, pain with intercourse, and changes in sexual functioning since starting AI therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Vaginal Dryness Dyspareunia Sexual Health Quality of Life |
Drug: Testosterone |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: A Pilot Study on the Effects of Vaginal Testosterone Therapy |
- Evaluate the effectiveness of a testosterone vaginal cream on the reported symptoms of vaginal dryness, pain with intercourse (dyspareunia), and sexual health quality of life related to aromatase inhibitor therapy in women with breast cancer. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Compare Female Sexual Function Index (FSFI) questionnaire scores [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]The FSFI questionnaire will be administered to participants prior to starting vaginal testosterone therapy and the survey will be repeated after using the study drug for 4 weeks. The FSFI is a 19-item multidimensional self-administered questionnaire and takes about 15 minutes to complete. The questionnaire uses a 5-point ordinal scale to assess six dimensions of sexual functioning over the past 4 weeks.
- Sexual Desire [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]FSFI Questionnaire
- Sexual Arousal [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]FSFI Questionnaire
- Orgasm Functioning [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]FSFI Questionnaire
- Dyspareunia (Pain With Intercourse) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]FSFI Survey
| Enrollment: | 12 |
| Study Start Date: | February 2013 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vaginal Testosterone
Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
|
Drug: Testosterone |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women with breast cancer
- Currently taking an aromatase inhibitor
- 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 HRT in the past three months, including systemic and local estrogen or testosterone therapy
Contacts and Locations More Information
No publications provided
| Responsible Party: | Melissa Dahir, Principal Investigator, Creighton University |
| ClinicalTrials.gov Identifier: | NCT01697345 History of Changes |
| Other Study ID Numbers: | MelissaDahir |
| Study First Received: | September 26, 2012 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Creighton University:
|
Vaginal Testosterone Vaginal atrophy Female Sexual Dysfunction Aromatase Inhibitors |
Additional relevant MeSH terms:
|
Breast Neoplasms Dyspareunia Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Sexual Dysfunction, Physiological Genital Diseases, Male Genital Diseases, Female Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Testosterone Testosterone enanthate Testosterone undecanoate |
Testosterone 17 beta-cypionate Methyltestosterone Aromatase Inhibitors Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013