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Vaginal Testosterone Cream For Atrophic Vaginitis in Women Taking Aromatase Inhibitors for Breast Cancer.

Phase 1/Phase 2
18 Years
Not Enrolling
Vaginitis, Dyspareunia, Breast Neoplasms

Thank you

Trial Information

Vaginal Testosterone Cream For Atrophic Vaginitis in Women Taking Aromatase Inhibitors for Breast Cancer.

Atrophic vaginitis is a condition in which the skin lining of the vagina and labia becomes
thin, usually due to a decreased estrogen state - such as menopause. Symptoms of atrophic
vaginitis include vaginal itching, vaginal discomfort and dyspareunia and can significantly
affect women's comfort, sexuality and quality of life.

Treatment for this condition includes estrogen given in pill form, commonly known as hormone
replacement therapy and local estrogen treatments, such as vaginal estrogen creams and
topical vaginal lubricants. Unfortunately, systemic estrogen is contraindicated in many
women with breast cancer. Some providers also feel that women who are taking aromatase
inhibitors for their breast cancer should also not use local estrogens as several small
studies suggest that these treatments might effect estrogen levels and thus might change how
effective the aromatase inhibitors are. If these women choose not to use any form of
estrogen therapy there symptoms may not be well controlled with other treatments.

The investigators hypothesize that a vaginal testosterone cream might be a safe and
effective alternative treatment for these women. This small study is intended to test the
hypothesis that testosterone cream will not increase estrogen (estradiol) levels and that it
will improve the symptoms of atrophic vaginitis including vaginal dryness, vaginal itching
and pain with intercourse.

The investigators will enroll women in the trial who are taking an aromatase inhibitor and
have the symptoms mentioned above. They will receive a testosterone cream which will be
applied vaginally once a day for 28 days. If good results are found with a prespecified dose
of testosterone, a lower dose will be tested in the next group of women enrolled.



1.1. Does topical testosterone cream affect serum estradiol levels in women taking aromatase
inhibitors for breast cancer?


1.2. Can atrophic vaginitis and resultant symptoms of vaginal dryness, itching and
dyspareunia in women taking aromatase inhibitors for the treatment of breast cancer be
improved with a topical testosterone cream?

1.3. Does topical testosterone cream affect physical findings, pH and cytologic changes in
atrophic vaginitis?


Intervention - Subjects will apply a testosterone cream to the vaginal area daily for one
month (28 days).

Evaluation - Before and after the study intervention participants will have testosterone and
high-sensitivity estradiol tested. They will complete a questionnaire on symptoms of
atrophic vaginitis and have a gynecologic examination (with visual, speculum, pH and sample
of vaginal epithelial cells.)

Endpoints - Serum estradiol levels Improvement in symptoms of atrophic vaginitis, as
measured by questionnaire. Atrophic vaginitis as measured by gynecological examination
(including pH and cytology to assess maturation index).

Inclusion Criteria:

- Histologically or cytologically confirmed breast cancer (any stage).

- Currently be using an aromatase inhibitor (anastrazole, exemestane or letrozole) for
primary or adjuvant breast cancer treatment.

- Must have complaints of vaginal itching, vaginal dryness and/or dyspareunia.

- Not undergoing active chemotherapeutic or radiotherapeutic treatment

- Age >18 years

- Life expectancy of greater than 2 months.

- CALGB (ZUBROD) performance status <3.

- Post-menopausal - defined by absence of menses for at least 12 months and/or an FSH
>25. Not post-menopausal as a function of medications intended to suppress ovarian
function, such as gonadotropin releasing hormone agonists. Surgically
post-menopausal subject eligible.

- The effects of topical testosterone cream on the developing human fetus at the
recommended therapeutic dose are unknown. For this study only post-menopausal women
are included and all women of child-bearing potential are excluded. Should a woman
become pregnant or suspect she is pregnant while participating in this study, she
should inform her treating physician immediately.

Exclusion Criteria:

- Patients who have not recovered from adverse events due to chemotherapeutic agents
administered more than 4 weeks earlier.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to testosterone or the emollient delivery cream used in the study.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant women and women who are breast-feeding are excluded from this study because
it is limited to post-menopausal women.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Serum estradiol levels

Outcome Description:

Will evaluate if serum estradiol levels, measured with a high sensitivity assay, increase in women taking aromatase inhibitors for breast cancer after study intervention of 28 days of vaginal testosterone treatment.

Outcome Time Frame:

28 days

Safety Issue:


Principal Investigator

Sabrina M Witherby, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Hospital of Rhode Island, Warren Alpert School od Medicine at Brown University


United States: Institutional Review Board

Study ID:




Start Date:

December 2006

Completion Date:

January 2011

Related Keywords:

  • Vaginitis
  • Dyspareunia
  • Breast Neoplasms
  • Testosterone
  • Vaginal administration
  • Aromatase inhibitors
  • Breast Neoplasms
  • Neoplasms
  • Dyspareunia
  • Vaginitis
  • Atrophy



Memorial Hospital of Rhode Island, Pawtucket, Rhode Island  02860
Fletcher Allen Health Care, University of Vermont Burlington, Vermont  05401