Savella in Treatment for Provoked Vestibulodynia
Condition: Vestibulodynia; Vulvodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Intervention: Milnacipran
Intervention description: 6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose) for 12 weeks - total treatment period is 18 weeks
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Maximum age: 54 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: provoked vestibulodynia; vulvodynia; PVD

Summary:

      The primary aim of this study is to determine the efficacy of milnacipran in reducing pain in
      women with provoked vestibulodynia (PVD), a centrally mediated pain syndrome similar to
      fibromyalgia, that is characterized by severe pain in the vestibule (outer vagina). The
      investigators will also determine whether associated symptoms in PVD, including psychological
      distress, impairment of sexual function, physical function, and quality of life, are
      correlated with a reduction in vulvar pain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. women between 18-54 years of age,

          2. 'Friedrich's Criteria' must be met (report greater than six continuous months of
             vulvar symptoms including insertional dyspareunia or pain to touch, demonstrate on
             physical exam moderate to severe tenderness to light touch, localized to the vulvar
             vestibule [positive Cotton Swab Test] and demonstration of variable degrees of
             erythema of the vestibule),

          3. an average pain level of "4" or greater on the 10-point tampon test and/or an average
             pain level of "4" or greater on the sexual intercourse pain scale(0 = no pain at all;
             10 = worse pain ever) during the 2-week screening period(see Study Parameters
             Section), and

          4. willing to use two forms of contraception during the study.

        Exclusion Criteria:

          1. other vulvar conditions, including dermatoses, vulvitis, vulvar papillomatosis, and
             atrophic vaginitis (presence of a maturation index),

          2. previous vestibulectomy,

          3. active vaginal infection,

          4. neuropathology, including seizure disorder or syncopal episodes,

          5. pregnancy or at risk for pregnancy and not using a reliable birth control method for
             at least 3 months prior to entering the study,

          6. breastfeeding,

          7. major medical illness including chronic liver disease/hepatic impairment, renal
             impairment, narrow-angle glaucoma, or uncontrolled hypertension,

          8. major psychiatric illness including substance abuse,

          9. multiple allergies (greater than three drugs or environmental agents),

         10. use of centrally-acting agents, including monoamine oxidase inhibitors,
             benzodiazepines, opiates, muscle relaxants, and antidepressants within 2 weeks of
             randomization and during the study, and

         11. use of topical lidocaine, within 2 weeks of randomization and during the study, as it
             has shown to be an effective treatment in some women, while worsening symptoms in
             others. Subjects will be permitted to take acetaminophen, aspirin, or a nonsteroidal
             anti-inflammatory drug as rescue medication. They will be provided with a list of
             allowable escape medications and those which would constitute a protocol deviation.