drugset / Trial / NCT01539317
Therapy to Prevent Sexual Pain in Breast Cancer Survivors
RandomizedCrossoverDouble-blindTreatment
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.
Timeline
- Start
- 2011-12
- Primary completion
- 2013-11
- Completion
- 2013-11
Publications
- Goetsch 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.
- Goetsch 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lidocaine | Other / unclassified | 4 % | Topical |