Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Atrophy

Dyspareunia

Breast Diseases

Skin Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Diseases, Male

Sexual Dysfunction, Physiological

Male Urogenital Diseases

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Quality of Life

All Drugs and Chemicals

Testosterone

Aromatase Inhibitors

Androgens

Hormones

Hormone Antagonists

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).

Melissa A Dahir, DNP

Dianne Travers-Gustafson, PhD

Robert Langdon, MD

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.

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

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

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.

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.

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.

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.

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.

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.

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.

Creighton University

Principal Investigator

Vaginal Testosterone

Age, Continuous

Sex: Female, Male

Married

Not Married

Marital Status

0-5 years

6-10 years

11-15 years

16-20 years

21-25 years

26-30 years

31-35 years

36-40 years

41-50 years

51-55 years

Length of Marriage

High school degree

Associate's degree

Bachelor's degree

Master's degree

Highest Level of Education

Oophorectomy

Estrogen-receptor (ER) Status

Progesterone-receptor (PR) Status

HER2+

HER2-

Human Epidermal Growth Factor Receptor 2 (HER2) Status

anastrozole (Arimidex)

letrozole (Femara)

exemestane (Aromasin)

Aromatase Inhibitor

No vaginal infection

Gardnerella vaginalis

Candidiasis species

A vaginal swab was obtained prior to prescribing testosterone therapy because women with suppressed estrogen levels have an increased risk of infection.

Vaginal Swab Test

Sexually Active Prior to Study

Sexually Active During Study

One patient withdrew due to symptoms of recurrent Gardnerella vaginalis.

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.

Dr. Melissa A Dahir

Administered to participants prior to starting vaginal testosterone therapy.

FSFI Total Score (Pretest)

Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).

FSFI Total Score (Postteset)

Total Female Sexual Function Index (FSFI) Score

FSFI Desire Domain Score (Pretest)

FSFI Desire Domain Score (Posttest)

FSFI Desire Domain

FSFI Arousal Domain Score (Pretest)

FSFI Arousal Domain Score (Posttest)

FSFI Arousal Domain

FSFI Lubrication Domain Score (Pretest)

FSFI Lubrication Domain Score (Posttest)

FSFI Lubrication Domain

FSFI Orgasm Domain Score (Pretest)

FSFI Orgasm Domain Score (Posttest)

FSFI Orgasm Domain

FSFI Satisfaction Domain Score (Pretest)

FSFI Satisfaction Domain Score (Posttest)

FSFI Satisfaction Domain

FSFI Pain Domain Score (Pretest)

FSFI Pain Domain Score (Posttest)

FSFI Pain Domain

Participants who chose to continue vaginal testosterone therapy upon completion of the study.

Continued Vaginal Testosterone Therapy

Participants who chose not to continue vaginal testosterone upon completion of the study.

Did Not Continue Vaginal Testosterone Therapy

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

Overall Study

Spots Global Cancer Trial Database for vaginal testosterone