Therapy to Prevent Sexual Pain in Menopausal Survivors of Breast Cancer
Subjects will be recruited primarily through provider referrals from Oncology, Center for
Women's Health, and The Breast Imaging Center. The Women's Health Research Unit will also
recruit by using print ads and craigslist.
For this study there will be three visits over a 5 month period. Subjects will undergo a
gynecological exam at the screening visit to determine the severity of pain associated with
uncomfortable intercourse. A touch test using Q-tips will be used during screening exam so
subjects can report pain during application of both study drug and placebo. Subjects will
also report pain during tampon test. A sample of vaginal cells and liquid will be obtained
at screening visit so that PI can rule out possible infection, disease, or disorders. PI
will also show subject the area of the vestibule in a mirror so that subject can apply study
drug at home properly. Subjects will fill out 4 questionnaires about medical and health
history, cancer history, pain, and distress and sexual activity. Subject will be given a
supply of either study drug or placebo to take home. The first visit will last approximately
Subjects will return for a second visit after 4 weeks and a third visit after 16 weeks for
diary review, questionnaires, and examination. The second and third visit examinations will
be repeats of the examination done at the first visit, but there will be no comparison with
placebo, the PI will use only study drug during the touch test. The second and third visits
will last approximately 1 hour.
Subjects will fill out questionnaires throughout study participation. Topics include;
medical and health history, cancer history, pain, distress and sexual activity. Subjects
will also fill out a diary that charts tampon test completed from home, sexual activity
performed, pain levels and study drug application days.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Entry dyspareunia relief
Decrease in reported pain by subjects on McGill Pain Questionnaire.
From the date of enrollment to 6 months
Martha Goetsch, MD
Oregon Health and Science University
United States: Institutional Review Board
OHSU IRB 7630
|Oregon Health & Science University||Portland, Oregon 97201|