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Lidocaine for sexual pain in menopausal breast cancer survivors
NCT01539317Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2011
- Primary completion
- Nov 2013
- Countries
- 1
- Sponsor
- OHSU Knight Cancer Institute
- Modality
- Small Molecules
- Conditions
- dyspareuniavulvodynia
01
Overview
Phase 3, randomised, double-blind trial of lidocaine 10% oropharyngeal spray in dyspareunia and vulvodynia, sponsored by OHSU Knight Cancer Institute. Primary endpoints: Prevention of Entry Dyspareunia at 12 weeks and Location of Pain in Postmenopausal Dyspareunia at 0 weeks. Started Dec 2011; status: completed.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Menopausal breast cancer survivors (18-70 years) with at least 6 months of consistent insertional pain with intercourse and a stable heterosexual partnership.
04
Endpoints
Primary
Prevention of Entry Dyspareunia
Location of Pain in Postmenopausal Dyspareunia
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