Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients (E-String)
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|ClinicalTrials.gov Identifier: NCT00698035|
Recruitment Status : Completed
First Posted : June 16, 2008
Results First Posted : June 2, 2014
Last Update Posted : June 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Sexual Dysfunction, Physiological||Drug: Testosterone Cream Drug: Estring||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||March 2007|
|Primary Completion Date :||October 2012|
|Study Completion Date :||December 2012|
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
- Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range [ Time Frame: 12 Weeks ]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 ]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 ]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 ]By serum ultrasensitive total testosterone test (Quest Diagnostics)
- Sexual Quality of Life [ Time Frame: Baseline, Week 4, Week 12 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|