Clinical trial · Interventional
Therapy to Prevent Sexual Pain in Breast Cancer Survivors
Therapy to Prevent Sexual Pain in Menopausal Survivors of Breast Cancer
NCT01539317CI-TRIAL-00027001completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Dyspareunia | — | UNRESOLVED | — |
| Menopause | — | UNRESOLVED | — |
| Vulvodynia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topical liquid lidocaine | Drug | — | UNRESOLVED |
| Topical saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Topical liquid lidocaine
- interventionNames
- Drug: Topical liquid lidocaine
- Drug: Topical saline
- type
- PLACEBO_COMPARATOR
- label
- Topical Saline
- interventionNames
- Drug: Topical liquid lidocaine
- Drug: Topical saline
Primary outcomes (2)
- measure
- Prevention of Entry Dyspareunia With Non-hormonal Therapy
- timeFrame
- During Phase II (0-4 weeks) and during Phase III (5-12 weeks)
- description
- Mean intercourse pain reported by subjects using the Numerical Rating Scale pain ratings (range 0-10, 0 being "no pain" and 10 being "worst possible pain"). Testing was during weeks 0-4 (Phase II) (with blinded randomization for placebo vs active intervention medication) and testing was during weeks 5-12 (Phase III) (with open-label active medication for 8 weeks after completing the blinded 4 weeks). Subjects agreed to try penetration twice per week and score their pain using the Numerical Rating Scale pain ratings.The scores were averaged during each phase.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDGoetsch MF, Lim JY, Caughey AB. A Practical Solution for Dyspareunia in Breast Cancer Survivors: A Randomized Controlled Trial. J Clin Oncol. 2015 Oct 20;33(30):3394-400. doi: 10.1200/JCO.2014.60.7366. Epub 2015 Jul 27. PMID 26215946
- DERIVEDGoetsch MF, Lim JY, Caughey AB. Locating pain in breast cancer survivors experiencing dyspareunia: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1231-1236. doi: 10.1097/AOG.0000000000000283. PMID 24807329