Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients
Condition: Sexual Dysfunction, Physiological
MeSH terms: Sexual Dysfunction, Physiological
Intervention: Testosterone Cream; Estring
Intervention description: 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment; 2mg ring inserted vaginally once every 12 weeks
Intervention MeSH terms: Methyltestosterone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate; Estradiol; Polyestradiol phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Vaginal Testosterone Cream; ESTRING

Summary:

      The purpose of this clinical research study is to determine whether the ESTRING or a special
      preparation of a testosterone cream inserted vaginally are safe for use in breast cancer
      patients. This study will also evaluate if either of these treatments can improve symptoms of
      vaginal dryness or decreased sexual interest that are related to your treatment for breast
      cancer.
    

Eligibility criteria:

        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
             analysis.

               -  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
                  ULN

          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
             products

          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.