Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: The Effects of Vaginal Testosterone Therapy

• ClinicalTrials.gov Identifier: NCT01697345
• Recruitment Status: Completed
• First Posted: October 2, 2012
• Results First Posted: January 24, 2014
• Last Update Posted: January 24, 2014
• Sponsor: Creighton University
• Information provided by (Responsible Party): Melissa Dahir, Creighton University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Vaginal Dryness; Dyspareunia; Sexual Health Quality of Life	Drug: Testosterone	Early Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: February 2013
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: May 2013

Arms and Interventions

Arm

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. Total Female Sexual Function Index (FSFI) Score [ Time Frame: Baseline, 4 weeks ]
   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.
2. FSFI Desire Domain [ Time Frame: Baseline, 4 weeks ]
   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.
3. FSFI Arousal Domain [ Time Frame: Baseline, 4 weeks ]
   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.
4. FSFI Lubrication Domain [ Time Frame: Baseline, 4 weeks ]
   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.
5. FSFI Orgasm Domain [ Time Frame: Baseline, 4 weeks ]
   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.
6. FSFI Satisfaction Domain [ Time Frame: Baseline, 4 weeks ]
   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.
7. FSFI Pain Domain [ Time Frame: Baseline, 4 weeks ]
   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.

Secondary Outcome Measures :

1. Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study [ Time Frame: After 4 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Nebraska

Nebraska Cancer Specialists/Midwest Cancer Center - Legacy

Omaha, Nebraska, United States, 68130

Sponsors and Collaborators

Creighton University

Investigators

• Principal Investigator: Melissa A Dahir, DNP; Creighton University
• Study Chair: Dianne Travers-Gustafson, PhD; Creighton University
• Study Director: Robert Langdon, MD; Nebraska Cancer Specialists

More Information

• Responsible Party: Melissa Dahir, Principal Investigator, Creighton University
• ClinicalTrials.gov Identifier: NCT01697345
• Other Study ID Numbers: MelissaDahir
• First Posted: October 2, 2012
• Results First Posted: January 24, 2014
• Last Update Posted: January 24, 2014
• Last Verified: December 2013

Keywords provided by Melissa Dahir, 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; Sexual Dysfunctions, Psychological; Mental Disorders; Testosterone; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs