Therapy to Prevent Sexual Pain in Breast Cancer Survivors

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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

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Vulvodynia Dyspareunia Breast Cancer Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Topical liquid lidocaine

Group Type ACTIVE_COMPARATOR

Topical liquid lidocaine

Intervention Type DRUG

active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule

Topical saline

Intervention Type DRUG

saline applied to the vestibule mucosa will not reverse the local tenderness

Topical Saline

Group Type PLACEBO_COMPARATOR

Topical liquid lidocaine

Intervention Type DRUG

active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule

Topical saline

Intervention Type DRUG

saline applied to the vestibule mucosa will not reverse the local tenderness

Interventions

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Topical liquid lidocaine

active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule

Intervention Type DRUG

Topical saline

saline applied to the vestibule mucosa will not reverse the local tenderness

Intervention Type DRUG

Other Intervention Names

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water

Eligibility Criteria

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Exclusion Criteria

1. Diagnosis of benign or malignant phyllodes tumor of the breast.
2. Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).
3. Has developed shrinkage of the vaginal opening or vaginal length to the point of being too small to succeed in having vaginal penetration with the partner (will also be assessed at the clinical exam).
4. Partner has a problem of sexual dysfunction limiting his performance or making it inconsistent.
5. The potential subject or her partner has a serious current medical condition that might interrupt completion of a 6 month study.
6. Potential subject has been diagnosed by a physical therapist with significant pelvic floor muscle dysfunction causing pain (pelvic floor myalgia).
7. Potential subject has used topical or systemic estrogen within the last 4 months.
8. Has continued tenderness of vestibule mucosa immediately after application of both test liquids.
9. Allergy to lidocaine or other numbing agents.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No