NCT01539317

Therapy to Prevent Sexual Pain in Breast Cancer Survivors

Therapy to Prevent Sexual Pain in Menopausal Survivors of Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this protocol is to determine whether pain with sexual intercourse can be reduced in menopausal, breast cancer survivors and to evaluate the effectiveness of a non-hormonal therapy (Lidocaine Liquid) vs. a placebo liquid in reducing pain. The investigators hypothesize that the pain arises in the vulvar vestibule. The investigators predict that the localized use of lidocaine will be more efficacious than use of placebo liquid.

Detailed description

For this study there will be three visits over a 3 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 2 hours. Subjects will return for a second visit after 4 weeks and a third visit after 8 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.

Conditions

• Vulvodynia
• Dyspareunia
• Breast Cancer
• Menopause

Interventions

Type	Name	Description
DRUG	Topical liquid lidocaine	active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule
DRUG	Topical saline	saline applied to the vestibule mucosa will not reverse the local tenderness

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-02-27
• Last updated: 2017-04-14
• Results posted: 2015-08-04

Locations

1 site across 1 country: United States