Conditions: Dysmenorrhea
Keywords: Dysmenorrhea Periods Menstrual Primary dysmenorrhea in women with recurrent dysmenorrhea
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 81
Healthy volunteers: yes

Brief summary:
The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared to placebo (inactive gel).

Detailed description:
The primary objective of this study is to evaluate the efficacy of 10% (150 mg) lidocaine gel compared with placebo in reducing the severity and onset of primary dysmenorrhea in women with recurrent dysmenorrhea.

The secondary objectives of this study are the following:

* to assess the safety of 10% (150 mg) lidocaine gel compared with placebo
* to evaluate electrocardiograms (ECGs) for potentially significant QT changes at approximate peak lidocaine plasma concentration after 4 days of dosing with 10% (150 mg) lidocaine gel.

Arms:
arm 1: Lidocaine 10% (150mg) vaginal gel arm 2: Placebo vaginal gel

Interventions: intervention 1: Lidocaine intervention 2: Placebo
Intervention descriptions: intervention 1: Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days intervention 2: Placebo vaginal gel administered once daily for 4 days

Protocol document: