Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients (E-String)
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.
Sexual Dysfunction, Physiological
Drug: Testosterone Cream
|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|
- Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol >10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was >10 pg/dl, subsequent levels >10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range.
- Serum Estradiol (E2) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]serial measurements of serum estradiol (E2) by liquid chromatography tandem mass spectrometry (Quest Diagnostics)
- Matched E2 by Commercial and Research (RIA) Analyses [ Time Frame: baseline, 4 weeks ] [ Designated as safety issue: No ]Serum estradiol assays sent to the UCSF clinical laboratory are sent out to Quest Diagnostics, which uses LC/MS for their ultra-sensitive estradiol assay. Samples were also sent to a specialized research lab in England which has developed an ultrasensitive assay using radioimmunoassay (RIA) after ether extraction (sensitivity limit of 3pmol/l) to quantify low levels of estradiol found in post-menopausal women
- Total Testosterone Levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]By serum ultrasensitive total testosterone test (Quest Diagnostics)
- Sexual Quality of Life [ Time Frame: Baseline, Week 4, Week 12 ] [ Designated as safety issue: No ]Cancer Rehabilitation Evaluation System (CARES) Sexual Dysfunction (SD) and Sexual Interest (SI) Subscales range from 0 to 4 and measure the severity of problems, with higher scores indicating more difficulty.
- Sexual Satisfaction [ Time Frame: Baseline, Week 4, Week 12 ] [ Designated as safety issue: No ]Participants were asked to respond to a Sexual Satisfaction One Item Measure which asked "Overall, how satisfactory to you is your sexual relationship with your partner?" Response options range from 1 (Extremely unsatisfactory) to 6 (Extremely satisfactory).
- Change in Vaginal Epithelium Scores [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]During a gynecologic exam, the vaginal epithelium was assessed by an examiner using the Vaginal Atrophy Scoring Scale to evaluate Rugae (lack of), Pallor (pinkness), Petechiae, Mucosal thinning, Dryness. Scores range from 0 (none) to 3 (severe); higher scores indicate less favorable outcomes.
|Study Start Date:||March 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Testosterone Cream
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: Estring
Estring 2mg ring inserted vaginally once every 12 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698035
|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|