Many women have cyclic BP that interferes with activities of daily living (ADL) and is non-responsive to analgesics. There is a need for non-hormonal interventions without adverse side effects (AE). Numerous publications suggest use of I2 for relief of cyclic BP but there has been no evaluation that includes validated assessments of BP, patient reported outcomes (PRO) for symptoms and ADL, and AE including potential impact of I on thyroid function (T).METHODS:
A multi-center, randomized, double-blind and placebo-controlled study is planned to evaluate the safety and effectiveness of I2 for cyclic BP. 120 women will be screened and asked to complete a daily diary for 2 cycles to capture baseline symptom severity. Subjects will have a baseline blood draw for T, a BP questionnaire (BPQ) with ADL questions and then randomized 2:1 to 3 mg/day commercially available oral I2 vs placebo for 6 months (m). Daily diary entries will continue for 6 m with BPQ, ADL and T assessed at 3 and 6 m. After 6 m, placebo subjects will be offered 3 m open label I2 and assessed with BPQ, ADL and T at the end of 3 m. All data other than T will be collected as PRO.RESULTS:
The primary endpoint is severity adjusted pain days for active vs placebo after 6 m. Secondary endpoints include T, AE, pain medication days and change in PRO measures.CONCLUSION:
A successful study will provide much needed data regarding the utility of I2 in the non-hormonal management of cyclic BP.