Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients
Information source: University of California, San Francisco
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sexual Dysfunction, Physiological
Intervention: Testosterone Cream (Drug); Estring (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s): Michelle Melisko, MD, Principal Investigator, Affiliation: University of California, San Francisco
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range
Secondary outcome: Serum Estradiol (E2)Matched E2 by Commercial and Research (RIA) Analyses Total Testosterone Levels Sexual Quality of Life Sexual Satisfaction Change in Vaginal Epithelium Scores
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Female.
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.
Locations and Contacts
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94115, United States
Additional Information
Starting date: March 2007
Last updated: May 27, 2014
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