Explanation of Study Design This study will be completed as a randomized, double-blind, placebo-controlled investigation with all eligible participants being randomized in an equal allocation (1:1:1:1) to each of the four study groups. Upon screening and providing consent, each study participant will complete baseline assessments and be randomized into one of four groups. Each participant will take their assigned supplement each day for 12 weeks. Approximately every four weeks participants will complete a series of questionnaires intended to evaluate menstrual symptoms, quality of life, gastrointestinal symptoms, health, and more specific menstrual symptoms specifically aligned around their menstrual cycle. Participants are allowed to stop their participation or withdraw at any time.
Supplementation Groups Placebo Effera300 (1 daily dose of 300 mg) Effera100 (1 daily dose of 100 mg) Effera2x100 (2 daily doses of 200 mg)
Participants will be randomized to one of the four arms of the study using simple randomization (ABAB) and an even allocation ratio (1:1:1:1).
Order of Study Procedures (See Study Table Below)
Week 0 (Day -28 to Day -3):
Informed consent process Eligibility determination via review of inclusion/exclusion criteria and medical/health history review Review medications Completion of online survey questionnaires (Menstrual symptoms questionnaire (MSQ-24), PROMIS Global Health 10 (PH-10), Patient Health Questionnaire (PHQ-4), PROMIS-GI Short Form) Complete menstrual complications symptoms questionnaire during first seven days of their next cycle Optional (If available): Sync their compatible wearable device to upload sleep and physical activity data Take first dose Report any adverse events
Weeks 1-3 Complete Patient Health Questionnaire (PHQ-4) each week Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events
Week 4 Complete menstrual complications symptoms questionnaire during first 7 days of menstrual cycle Completion of online survey questionnaires (Menstrual symptoms questionnaire (MSQ-24), PROMIS Global Health 10 (PH-10), Patient Health Questionnaire (PHQ-4), PROMIS-GI Short Form) Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events
Weeks 5-7 Complete Patient Health Questionnaire (PHQ-4) each week Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events
Week 8 Complete menstrual complications symptoms questionnaire during first 7 days of menstrual cycle Completion of online survey questionnaires (Menstrual symptoms questionnaire (MSQ-24), PROMIS Global Health 10 (PH-10), Patient Health Questionnaire (PHQ-4), PROMIS-GI Short Form) Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events
Weeks 9-11 Complete Patient Health Questionnaire (PHQ-4) each week Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events
Week 12 Complete menstrual complications symptoms questionnaire during first 7 days of menstrual cycle Completion of online survey questionnaires (Menstrual symptoms questionnaire (MSQ-24), PROMIS Global Health 10 (PH-10), Patient Health Questionnaire (PHQ-4), PROMIS-GI Short Form) Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data through completion of final assessments Continue taking assigned supplement through completion of final assessments
Study Table Action (Weeks) Information (0) Demographics (0) Inclusion/Exclusion Review (0) Medical/health history review (0) Medication Review (0) Menstrual Symptoms Questionnaire-24 (MSQ-24) (0, 4, 8, 12) PROMIS Global Health (0, 4, 8, 12) Patient Health (PHQ-4) (0, 1, 2, 3, 4, 5, 6, 6, 7, 8, 9, 10, 11, 12) PROMIS-GI Combined Short Form (0, 4, 8, 12) Menstrual Cycle Comfort Questionnaire (Days before mensense, 0, 4, 8, 12) Optional: Sleep \& Physical Activity Tracker (0, 1, 2, 3, 4, 5, 6, 6, 7, 8, 9, 10, 11, 12) Supplement Compliance (0, 1, 2, 3, 4, 5, 6, 6, 7, 8, 9, 10, 11, 12) Adverse Event Reporting (0, 1, 2, 3, 4, 5, 6, 6, 7, 8, 9, 10, 11, 12)
