Phase 3
N=50
Therapy to Prevent Sexual Pain in Breast Cancer Survivors
Vulvodynia · Dyspareunia · Breast Cancer · Menopause
Bottom Line
View on ClinicalTrials.gov: NCT01539317 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Prevention of Entry Dyspareunia With Non-hormonal Therapy — 5.3; 1.04; NA; 0.57 Units on a scale — p=0.0149
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Topical liquid lidocaine (Drug); Topical saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- OHSU Knight Cancer Institute
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevention of Entry Dyspareunia With Non-hormonal Therapy |
5.3; 1.04; NA; 0.57; 0.45; 0.48 | 0.0149 sig |
| PRIMARY Location of Pain in Postmenopausal Dyspareunia |
0; 0; 0; 0; 1; 0 | <0.001 sig |
| SECONDARY Improvement of Quality of Sexual Life - Visit 1 |
11.91; 13.87; 8.44; 9.15; 3.92; 2.97 | 0.66 |
| SECONDARY Improvement of Quality of Sexual Life - Visit 2 |
14; 16.09; 8.14; 11.21; 3.59; 4.18 | — |
| SECONDARY Improvement of Quality of Sexual Life - Visit 3 |
17.79; 18.32; 10.89; 13.15; 4.79; 5.2 | — |
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.
Eligibility Criteria
Eligibility Criteria
- Women aged 18 to 70 years old.
- Has a previous diagnosis of breast cancer (ductal or lobular carcinoma, invasive).
- 1 year from diagnosis of breast cancer.
- Stable heterosexual partnership =/>5 years or by investigator discretion.
- More than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain).
- 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).
- Willingness to enter a study comparing a topical placebo liquid to topical liquid lidocaine.
- 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
- Diagnosis of benign or malignant phyllodes tumor of the breast.
- Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).
- 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).
- Partner has a problem of sexual dysfunction limiting his performance or making it inconsistent.
- The potential subject or her partner has a serious current medical condition that might interrupt completion of a 6 month study.
- Potential subject has been diagnosed by a physical therapist with significant pelvic floor muscle dysfunction causing pain (pelvic floor myalgia).
- Potential subject has used topical or systemic estrogen within the last 4 months.
- Has continued tenderness of vestibule mucosa immediately after application of both test liquids.
- Allergy to lidocaine or other numbing agents.
Data sourced from ClinicalTrials.gov (NCT01539317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.