Efficacy and Safety Study of Lidocaine Vaginal Gel for Recurrent Dysmenorrhea (Painful Periods)
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Intervention: Lidocaine; Placebo
Intervention description: Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days; Placebo vaginal gel administered once daily for 4 days
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dysmenorrhea; Periods; Menstrual; Primary dysmenorrhea in women with recurrent dysmenorrhea

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).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Experiences primary dysmenorrhea requiring pain medication for moderate-to-severe pain
             (as measured by a 4-point categorical rating scale) by the subject's own report for at
             least four of the previous six menstrual cycles.

          2. Has a history of primary dysmenorrhea with onset within 4 years of menarche.

          3. Has regular menstrual cycles (i.e. onset of menses predictable within 1 - 2 days each
             month) for the 3 month period preceding enrollment. If a subject has had regular
             cycles for the past 12 months but had a single cycle that was not regular within the 3
             month period preceding enrollment, the subject may be enrolled at investigator
             discretion after consultation with sponsor.

          4. Taking the same strength and type of hormonal contraception on a monthly cycle for at
             least the previous 6 months prior to screening and plans to remain on this hormonal
             contraception for the duration of participation in the study or is on an acceptable
             method of birth control including surgical sterilization (i.e. bilateral tubal
             ligation, partner vasectomy), double-barrier methods, and total abstinence (at the
             discretion of the investigator in cases where age, career, lifestyle, or sexual
             orientation of the patient ensures compliance).

          5. Is a tampon user and/or must be willing to use tampons throughout the study dosing
             period.

          6. Age 18 to 40 years (inclusive).

          7. Has a Body Mass Index (BMI) ≤ 35 kg/m2.

          8. Able to understand and willing to complete the efficacy evaluations.

          9. Able to speak and understand English, and must give written informed consent for the
             study.

        Exclusion Criteria:

          1. Unable, in the opinion of the Investigator, to comply fully with any of the study
             requirements.

          2. Experiencing pelvic pain other than that thought to be associated with primary
             dysmenorrhea, such as chronic pelvic pain occurring at times other than exclusively
             during menses and/or dyspareunia.

          3. Experiencing dysmenorrhea symptoms that are effects of or thought to be effects of (at
             least in part) secondary causes of dysmenorrhea, such as uterine fibroids,
             endometriosis, and/or currently symptomatic ovarian cysts.

          4. Experienced dysmenorrhea that did not require, in the opinion of the subject, the use
             of analgesic medication during four of the previous six menstrual episodes.

          5. Has dysmenorrhea refractory to treatment with commonly used analgesic medications for
             the treatment of menstrual pain (e.g., ibuprofen or naproxen sodium).

          6. Use of any Class I antiarrhythmic drug.

          7. Currently using contraceptive injection, implant, or extended cycle OC (hormonal
             contraceptive cycles consisting of 28 days or more of active hormones).

          8. Pregnant or breastfeeding.

          9. Participated in a clinical trial in the 30 days from the time of last dosing in the
             prior study to the time of providing consent for this study.

         10. Previously randomized into this study.

         11. A history of allergic hypersensitivity or significant intolerance (including
             angioedema, urticaria, bronchospasm, and rhinitis) related to treatment with any
             medications used in this study.

         12. A history of past or ongoing clinically significant disease, illness, or disorder
             that, in the opinion of the Investigator, makes the subject unsuitable for study
             participation including active vaginal, vulvar, and cervical lesions.

         13. Laboratory abnormalities that, in the opinion of the Investigator, could
             contraindicate study participation such as liver function tests > 1.5 times the upper
             limit of normal (At the Investigator's discretion, laboratory tests may be repeated
             once for verification.)

         14. A history of, within the past 4 years, or ongoing significant psychiatric illness
             that, in the opinion of the Investigator, makes the subject unsuitable for study
             participation.

         15. A history of chronic analgesic or tranquilizer use or drug abuse including alcohol
             within the 6 months before providing consent for this study.

         16. Regular use of any concomitant medications that might confound efficacy and/or safety
             assessments, in the opinion of the Investigator, including, but not limited to, the
             following: psychotropic drugs, antidepressants, sedative-hypnotics, sedating
             antihistamines, or tranquilizers for 24 hours or five half-lives prior to providing
             informed consent until 24 hours after the final treatment cycle. Selective serotonin
             reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), and
             St. John's Wort are permitted for indications other than pain if the subject has been
             on a stable dose for at least 2 weeks before providing consent for this study and
             agrees to remain on a stable dose throughout the course of the study.

         17. Unwilling to use only those medications that are allowed in the study for the
             treatment of their dysmenorrhea, i.e., study drug and rescue medication.

         18. Any ongoing vaginal infection requiring intravaginal treatment.

         19. A history of toxic shock syndrome (TSS).