WOMANIZER STUDY OVERVIEW


Proof of Concept
Primary Endpoints –
1. FSFI questions 11-13 orgasmic domain focus (Goal of 1 point change in orgasmic domain – 15 total points)
2. FSFI total score (Goal of 3 point change in overall questionnaire)
3. FSDS-R total score (Goal of 6.5 point change in overall questionnaire)

Secondary Endpoint –
1. FIEI question #5 – descriptive statistics (% of women that noted improvement)
2. Questions 3a, b & 6a global assessment questionnaire 


Patient Inclusion Criteria

  • Age 38 +
  • Secondary, generalized, orgasmic dysfunction
  • FSFI orgasmic domain < /=9
  • Overall FSFI score </=26
  • FSDS-R total score >/=11
  • Postmenopausal status (without menses >1yr

​           or

  • Perimenopausal status based on change in menstrual pattern

           or

           3+ symptoms listed below

  • Hot flashes/night sweats
  • Weight gain
  • Abdominal bloating
  • Fatigue
  • Sleeping difficulties/insomnia
  • Moodiness
  • Cognitive changes
  • Hair Loss
  • Vaginal dryness
  • Low libido


Other Criteria

  • Single or partnered, any sexual orientation
  • May have sexual comorbities although orgasmic dysfunction must be most bothersome sexual concern
  • Must be willing/able to use the Womanizer at least twice weekly x 4 weeks and complete questionnaires at baseline and end of 4 week
  • Following meds not exclusionary although no change in baseline meds during 4 week trial with Womanizer. Patients have option to start HRT after completion of 4 week trial if desired by patient and appropriate based on medical evaluation
  • Antidepressants including SSRIs
  • Hormone replacement therapy (must have been on for >3 months)
  • Oral contraceptive agents
  • SERMs


Protocol (N = 20):
Baseline

  • FSFI
  • FDSD-R
  • SF-36

4 weeks:

  • FSFI
  • FSDS-R
  • Global Assessment Questionnaire with PGI-I
  • SF-36
  • FIEI