Skip to main content
OpenTrials
Completed

NCT Number: NCT01697345

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Sexual Health Quality of Life Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Vaginal Dryness

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Nebraska Cancer Specialists/Midwest Cancer Center - Legacy

Omaha, Nebraska, 68130, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone

Drug

Primary outcomes

  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 outcomes

  1. Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study

    Time frame: After 4 weeks

Sponsors and collaborators

Lead sponsor

Creighton University

Other

Registry information

Official study title

Breast Cancer, Aromatase Inhibitor Therapy, and Sexual Functioning: A Pilot Study on the Effects of Vaginal Testosterone Therapy

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 2, 2012
Registry last updated
Jan 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.