Preventing Sexual Dysfunction With Aromatase Inhibitors
Completed · Phase 2
Conditions studied: Breast Cancer
In brief
Aromatase inhibitors (AIs) are used to try to stop breast cancer from forming or returning after treatment in women who are in menopause and who had breast cancer that was sensitive to the hormone estrogen. The goal of this study is to learn if it is possible to prevent some AI side effects, particularly problems with vaginal dryness and pain during sexual activity. Researchers also want to compare 2 new vaginal moisturizers to see if using them regularly helps women avoid vaginal dryness. Researchers want to see if preventing these side effects will decrease the number of women who stop taking AIs due to the side effects they cause.
Key facts
- Study ID
- NCT01603303
- Run by
- M.D. Anderson Cancer Center
- People needed
- 187
- Starts
- 2012-12-05
- Expected to finish
- 2017-08-11
- Last updated by the study team
- 2017-08-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of Stage 0 to III breast cancer
- Age over 18 years
- Began adjuvant therapy with an aromatase inhibitor 12 to 18 months before survey sent out (Benchmark Survey only)
- Was prescribed adjuvant therapy with an AI (prior chemotherapy or tamoxifen OK) in past 2 to 4 weeks (Randomized Trial only)
- Had sexual activity at least once in past 12 months (Randomized Trial Study only)
- Has been in a stable sexual relationship of at least 6 months' duration (Randomized Trial study only)
You may not qualify if…
- Women using systemic or vaginal estrogen, testosterone, or dehydroepiandrosterone (DHEA) during the Randomized Trial study will be excluded
- Women using systemic or vaginal estrogen, testosterone, or dehydroepiandrosterone (DHEA) in the 12 months preceding the Benchmark Survey Study will be excluded
- Has distant metastases
- Cannot read or speak English well enough to understand materials and complete questionnaires
- No access to the internet in a private location
Where it is running
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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