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Therapy to Prevent Sexual Pain in Menopausal Survivors of Breast Cancer

Phase 3
18 Years
65 Years
Open (Enrolling)
Vulvodynia, Dyspareunia, Breast Cancer, Menopause

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Trial Information

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
2 hours.

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.

Inclusion Criteria:

1. Women aged 18 to 65 years old.

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

3. 2 years 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. At least 2 years of menopause, demonstrated by at least one of the following:

- cessation of menses for 2 years

- Bilateral oophorectomy

- 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

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.

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

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Entry dyspareunia relief

Outcome Description:

Decrease in reported pain by subjects on McGill Pain Questionnaire.

Outcome Time Frame:

From the date of enrollment to 6 months

Safety Issue:


Principal Investigator

Martha Goetsch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University


United States: Institutional Review Board

Study ID:




Start Date:

December 2011

Completion Date:

December 2012

Related Keywords:

  • Vulvodynia
  • Dyspareunia
  • Breast Cancer
  • Menopause
  • Vulvodynia
  • Dyspareunia
  • Breast Cancer
  • Menopause
  • Vaginal dryness
  • Painful intercourse
  • Breast Neoplasms
  • Dyspareunia
  • Vulvodynia



Oregon Health & Science UniversityPortland, Oregon  97201