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

NCT01697345 | Completed Early Phase 1 Results

• 1 other identifier: MelissaDahir
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Vaginal Dryness; Dyspareunia; Sexual Health Quality of Life

Keywords

Vaginal Testosterone; Vaginal atrophy; Female Sexual Dysfunction; Aromatase Inhibitors

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study

  After 4 weeks

Study Arms (1)

Vaginal Testosterone

EXPERIMENTAL

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

Interventions

Testosterone DRUG

Vaginal Testosterone

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

Nebraska Cancer Specialists/Midwest Cancer Center - Legacy

Omaha, Nebraska, 68130, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Dyspareunia

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Limitations and Caveats

Limitations of this pilot study included the narrow time frame for enrollment, the exclusion of surgically menopausal women under the age of 50, and symptoms of recurrent Gardnerella vaginalis.

Results Point of Contact

• Title: Dr. Melissa A Dahir
• Organization: Creighton University

melissadahir@creighton.edu

402-657-2847

Study Officials

• Melissa A Dahir, DNP

  Creighton University

  PRINCIPAL INVESTIGATOR

• Dianne Travers-Gustafson, PhD

  Creighton University

  STUDY CHAIR

• Robert Langdon, MD

  Nebraska Cancer Specialists

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: October 2, 2012
• Study Start: February 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 24, 2014
• Results First Posted: January 24, 2014

Record last verified: 2013-12

Locations

US (1)