Therapy to Prevent Sexual Pain in Breast Cancer Survivors

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.

Eligibility Criteria

1. Women aged 18 to 70 years old.

2. Has a previous diagnosis of breast cancer (ductal or lobular carcinoma, invasive).

3. 1 year from diagnosis of breast cancer.

4. Stable heterosexual partnership =/>5 years or by investigator discretion.

5. More than 6 months of consistent insertional pain with intercourse (may have stopped
having intercourse due to this consistent experience of pain).

6. Menopausal, demonstrated by at least one of the following:

i. cessation of menses for 1 years ii. Bilateral oophorectomy iii. Follicle
Stimulating Hormone (FSH) level >25 in women below age 50 with an ovary and scarred
or absent uterus (acceptable FSH levels can be inferred if the woman's oncologist
monitors FSH during aromatase inhibitor therapy).

7. Willingness to enter a study comparing a topical placebo liquid to topical liquid
lidocaine.

8. Willingness to evaluate the liquids by use of a tampon test as many as 4 times per
month, and willingness to attempt intercourse if the tampon test indicates tolerable
penetrative pain.

3.2 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.