Chronic Pain Risk Associated With Menstrual Period Pain

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine if some women with dysmenorrhea (painful periods) are at higher future risk of developing chronic pelvic pain (CPP) and if oral contraceptives (OC) can be used to reverse this chronic pain risk.

Investigators will examine whether dysmenorrhea produces CPP via repetitive cross organ sensitization (COS) episodes. The use of cyclical OCs to eliminate dysmenorrhea is expected to reduce COS and decrease the risk of developing CPP.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NorthShore University HealthSystem; NorthShore University HealthSystem Research Institute
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes of Health (NIH)
• Treatments: Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination

Criteria

Inclusion Criteria:

All

• Reproductive age women (18-45)

For dysmenorrhea and D+COS group only:

• Participants must have had regular (22-45 day) menstrual cycles over at least a two month period preceding testing

Exclusion Criteria:

All

• presence of active pelvic or abdominal malignancies (primary or metastatic)

• active genitourinary infection in the last four weeks

• unable to read or comprehend the informed consent in English

• unwilling to undergo pelvic examination/testing

• presence of hypertension or risk for developing hypertension, and

For dysmenorrhea and D+COS group only:

• absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding) unwilling to take either cyclic or combined OCs

• unwilling to withdraw from OCs for two months prior to the Aim #1 study visit.