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| Sponsor: | University of California, San Francisco |
|---|---|
| Information provided by (Responsible Party): | Michelle Melisko, 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| 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: | February 2012 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: I
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
Other Name: intravaginal testosterone cream
|
|
Active Comparator: II
Estring 2mg ring inserted vaginally once every 12 weeks
|
Drug: Estring
2mg ring inserted vaginally once every 12 weeks
Other Name: ESTRING Estrodial Vaginal Ring
|
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 |
Inclusion Criteria:
Postmenopausal estradiol levels at baseline as measured by standard laboratory analysis.
Adequate hematologic, hepatic, and renal function as defined by:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Principal Investigator: | Michelle Melisko, MD | University of California, San Francisco |
More Information
| Responsible Party: | Michelle Melisko, Assistant Clinical Professor, Hem/Onc, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00698035 History of Changes |
| Other Study ID Numbers: | UCSF-067519 |
| Study First Received: | June 11, 2008 |
| Last Updated: | October 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Vaginal Testosterone Cream ESTRING |
|
Breast Neoplasms Sexual Dysfunction, Physiological Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Genital Diseases, Male Genital Diseases, Female Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Estradiol Polyestradiol phosphate |
Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Aromatase Inhibitors Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents Estrogens Contraceptive Agents |