Design: Single site, randomized, double blinded, placebo controlled, cross-over pilot clinical study.

Setting: Specialty clinic at an academic institution.

Patients or Participants: Eligible participants were females aged 18-45 years with menstrual cycles every 24-32 days and menstrual periods lasting no more than 10 days. Subjects had moderate to severe dysmenorrhea and either a surgical diagnosis of endometriosis or ultrasound evidence of endometrioma.

Interventions: Subjects were randomly assigned in a double-blind fashion to receive either the study drug (Anakinra) or placebo administered as daily injections during the first 3 periods and then the alternate intervention for the next 3 periods.

Measurements and Main Results: 15 subjects completed the 6 menstrual cycle study. After each period, they completed the Endometriosis Health Profile-30 (EHP-30) QoL questionnaire and an assessment of dysmenorrhea using a 0-100 Visual Analogue Scale (VAS). All domains of the EHP-30 showed a trend towards improvement with statistically significant improvements in powerlessness (54.5 vs. 63.3, p = 0.04) and self-image (58.1 vs. 66.7, p = 0.03) on the study drug compared to placebo. The mean dysmenorrhea VAS also trended toward improvement with a score of 37.5 during active treatment and 42.6 with placebo (p = 0.26). No difference in menstrual cycle length was detected (29.3 days vs 27.7 days, p=0.56).

Conclusion: With all domains of the EHP-30 and the dysmenorrhea VAS consistently showing either a statistical improvement or trend towards improvement, there is justification for a larger study. Furthermore, since no impact on menstrual cycles was detected, Anakinra may be a particularly impactful option for women desiring fertility.