Status:
COMPLETED
Chronic Pain Risk Associated With Menstrual Period Pain
Lead Sponsor:
Endeavor Health
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Cystitis, Interstitial
Dysmenorrhea
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief 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 use...
Detailed Description
Endometrial shedding during the menstrual cycle elicits profound changes in neuronal activity and cytokine concentrations producing moderate to severe pelvic pain in more than 20% of reproductive-age ...
Eligibility Criteria
Inclusion
- 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
- 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 sensory testing study visit.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
353 Patients enrolled
Trial Details
Trial ID
NCT02214550
Start Date
July 1 2014
End Date
January 1 2021
Last Update
June 18 2023
Active Locations (1)
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1
NorthShore University Health System
Evanston, Illinois, United States, 60201