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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00698035 |
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 |
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Sexual Dysfunction, Physiological |
Drug: Testosterone Cream Drug: Estring |
Phase II |
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 |
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 |
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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
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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
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II: Active Comparator
Estring 2mg ring inserted vaginally once every 12 weeks
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Drug: Estring
2mg ring inserted vaginally once every 12 weeks
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Postmenopausal estradiol levels at baseline as measured by standard laboratory analysis.
Adequate hematologic, hepatic, and renal function as defined by:
Exclusion Criteria:
Contact: Amy DeLuca | 415-353-7288 | delucaa@cc.ucsf.edu |
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Principal Investigator: Michell Melisko |
Principal Investigator: | Michelle Melisko, MD | University of California, San Francisco |
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 |
Vaginal Testosterone Cream ESTRING |
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 |
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 |