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Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients (E-String)
This study is currently recruiting participants.
Verified by University of California, San Francisco, June 2008
First Received: June 11, 2008   Last Updated: February 23, 2009   History of Changes
Sponsored by: University of California, San Francisco
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00698035
  Purpose

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.


Condition Intervention Phase
Sexual Dysfunction, Physiological
Drug: Testosterone Cream
Drug: Estring
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Estradiol Estradiol 3-benzoate Testosterone Propionate Methyltestosterone Testosterone Polyestradiol phosphate Depogen Estradiol dipropionate Oxymesterone Estradiol cypionate Testosterone enanthate Estradiol valerate Estradiol acetate Testosterone undecanoate
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Document the systemic estradiol and testosterone levels at several time points [ Time Frame: Study Completion ] [ Designated as safety issue: No ]
  • Compare standard clinical laboratory measurements of serum estradiol with values of serum estradiol as measured by an ultrasensitive assay in a research laboratory [ Time Frame: Study Completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: March 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Active Comparator
Testosterone Cream 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
Drug: Testosterone Cream
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
II: Active Comparator
Estring 2mg ring inserted vaginally once every 12 weeks
Drug: Estring
2mg ring inserted vaginally once every 12 weeks

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698035

Contacts
Contact: Amy DeLuca 415-353-7288 delucaa@cc.ucsf.edu

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Principal Investigator: Michell Melisko            
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Michelle Melisko, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center ( Michelle Melisko, MD, Prinicpal Investigator )
Study ID Numbers: UCSF-067519
Study First Received: June 11, 2008
Last Updated: February 23, 2009
ClinicalTrials.gov Identifier: NCT00698035     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Vaginal Testosterone Cream
ESTRING

Study placed in the following topic categories:
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Estradiol 17 beta-cypionate
Hormones
Genital Diseases, Female
Sexual Dysfunction, Physiological
Estradiol 3-benzoate
Polyestradiol phosphate
Aromatase Inhibitors
Breast Diseases
Estrogens
Skin Diseases
Antineoplastic Agents, Hormonal
Benzoates
Breast Neoplasms
Methyltestosterone
Genital Diseases, Male
Estradiol
Testosterone 17 beta-cypionate
Testosterone
Anabolic Agents
Androgens

Additional relevant MeSH terms:
Contraceptive Agents
Antineoplastic Agents
Estradiol valerate
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Estradiol 17 beta-cypionate
Hormones
Genital Diseases, Female
Neoplasms by Site
Sexual Dysfunction, Physiological
Estradiol 3-benzoate
Therapeutic Uses
Polyestradiol phosphate
Breast Diseases
Estrogens
Skin Diseases
Antineoplastic Agents, Hormonal
Breast Neoplasms
Methyltestosterone
Genital Diseases, Male
Estradiol
Pharmacologic Actions
Testosterone 17 beta-cypionate
Testosterone
Neoplasms
Anabolic Agents
Androgens

ClinicalTrials.gov processed this record on May 07, 2009