Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Therapy to Prevent Sexual Pain in Breast Cancer Survivors

This study has been completed.
Information provided by (Responsible Party):
OHSU Knight Cancer Institute Identifier:
First received: December 21, 2011
Last updated: July 7, 2015
Last verified: July 2015

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.

Condition Intervention Phase
Breast Cancer
Drug: Topical liquid lidocaine
Drug: Topical saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Therapy to Prevent Sexual Pain in Menopausal Survivors of Breast Cancer

Resource links provided by NLM:

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Prevention of Entry Dyspareunia With Non-hormonal Therapy [ Time Frame: From the date of enrollment to 6 months ] [ Designated as safety issue: No ]
    Decrease in reported pain by subjects on using pain ratings and pain scale questionnaires

  • Location of Pain in Postmenopausal Dyspareunia [ Time Frame: Enrollment visit ] [ Designated as safety issue: No ]
    To determine the specific site of vulvovaginal tenderness in menopausal breast cancer survivors who have entry dyspareunia. Examine the vulvar vestibule with a swab test to determine locations and severity of touch tenderness. Eight sites were evaluated around the vaginal opening and there location was in reference to a clock face. Measured using the Numerical Rating Scale, a scale which measures pain from 0 to 10 with 0="no pain" and 10="the worst pain you have ever felt".

Secondary Outcome Measures:
  • Improvement of Quality of Sexual Life. [ Time Frame: From time of enrollment until 6 months later ] [ Designated as safety issue: No ]
    To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by improved scores on the Female Sexual Distress Scale and the Sexual Function Questionnaire.

Enrollment: 50
Study Start Date: December 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Topical liquid lidocaine 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
Other Name: water
Placebo Comparator: Topical Saline 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
Other Name: water

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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01539317

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Principal Investigator: Martha Goetsch, MD Oregon Health and Science University
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: OHSU Knight Cancer Institute Identifier: NCT01539317     History of Changes
Other Study ID Numbers: OHSU IRB 7630 
Study First Received: December 21, 2011
Results First Received: June 5, 2015
Last Updated: July 7, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by OHSU Knight Cancer Institute:
Breast Cancer
Vaginal dryness
Painful intercourse

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Mental Disorders
Vulvar Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on January 14, 2017