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A Phase II Study of Vaginal Testosterone Cream vs. the ESTRING for Vaginal Dryness or Decreased Libido in Early Breast Cancer Patients Treated With Aromatase Inhibitors

Phase 2
18 Years
80 Years
Open (Enrolling)
Sexual Dysfunction, Physiological

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Trial Information

A Phase II Study of Vaginal Testosterone Cream vs. the ESTRING for Vaginal Dryness or Decreased Libido in Early Breast Cancer Patients Treated With Aromatase Inhibitors

There is a growing body of scientific literature to suggest that sexual functioning is one
of the most distressing problems experienced by breast cancer survivors. Vaginal dryness,
dyspareunia (pain during sexual intercourse), and decreased libido are common complaints
among breast cancer patients. With increasing use of aromatase inhibitors which are
associated with a higher rate of vaginal dryness than tamoxifen, these problems are becoming
even more prominent. This study will evaluate the safety and tolerability of the ESTRING
and 1% testosterone cream administered vaginally as treatments for vaginal dryness and/or
decreased libido in women receiving an aromatase inhibitor for early stage breast cancer.

Inclusion Criteria:

1. Histologically or cytologically confirmed Stage I-III breast cancer who are taking an
aromatase inhibitor as adjuvant hormonal therapy. Patient must have started the
aromatase inhibitor at least 60 days prior to enrolling.

2. Postmenopausal estradiol levels at baseline as measured by standard laboratory

- Patient may be rendered postmenopausal through the use of a GnRH agonist, but
must have confirmed post-menopausal levels of serum estradiol on two lab tests
at least one month apart.

- If patient has been rendered post-menopausal by adjuvant chemotherapy but has
had a period within the past 12 months, post-menopausal levels of serum
estradiol must be documented on two lab tests at least 3 months apart.

3. Age ≥18 and ≤80 years old.

4. ECOG ≤1

5. Adequate hematologic, hepatic, and renal function as defined by:

- Hgb ≥9 g/dL

- Absolute neutrophil count (ANC)/absolute granulocyte count (AGC) ≥1500 cells/mm3

- Platelet count ≥100,000/mm3

- Serum creatinine ≤1.5 mg/dL

- Total bilirubin ≤1.5 times the ULN; and aspartate aminotransferase ≤3 times the

6. Normal thyroid function tested within the past 6 months (Patients with a diagnosis of
hypothyroidism and on thyroid supplementation must have had thyroid function tests in
the normal range within the past 3 months)

7. Patient must have recovered from the side effects of previous chemotherapy, surgery,
or radiation therapy for early breast cancer.

Exclusion Criteria:

1. History of radiation to the vaginal area

2. Concurrent treatment with any type of oral, injectable or topical form of estrogen or
androgen therapy including natural supplements marketed as hormone replacement

3. Initiation of topical moisturizers (for example, Replens), or herbal or alternative
medicines to manage the symptoms of vaginal dryness while on study. Patients who were
previously using these products may continue them with the same usage pattern while
on study.

4. Use of vaginal hormonal products (rings, inserts, creams, gels) containing estrogens
or androgens within the past 30 days.

5. History of an abnormal pap smear within the last 12 months

6. History of endometrial or ovarian cancer

7. Any episode of vaginal bleeding in the past 6 months that has not been evaluated by a
gynecological exam and/or pelvic ultrasound

8. History of sexual dysfunction prior to diagnosis of breast cancer ( Sexual
dysfunction will be defined as loss of libido or inability to achieve orgasm for
which patient sought medical attention or which patient felt significantly interfered
with quality of life.)

9. Moderate or severe depression for which the patient is receiving ongoing
psychological counseling and/or taking antidepressants, and for whom, in the
investigators opinion may be interfering in the patients sexual function independent
of the side effects of breast cancer and aromatase inhibitor use.

10. Use of any investigational agent for breast cancer within 3 weeks of study entry.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Evaluate safety, based on serial measurements of serum estradiol levels, of testosterone cream or the ESTRING administered for relief of vaginal dryness and/or decreased libido related to aromatase inhibitor therapy in early breast cancer patients

Outcome Time Frame:

Study Completion

Safety Issue:


Principal Investigator

Michelle Melisko, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Institutional Review Board

Study ID:




Start Date:

March 2007

Completion Date:

December 2012

Related Keywords:

  • Sexual Dysfunction, Physiological
  • Vaginal Testosterone Cream
  • Breast Neoplasms
  • Sexual Dysfunctions, Psychological
  • Sexual Dysfunction, Physiological



UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115