Phase 4
Completed N=353
Chronic Pain Risk Associated With Menstrual Period Pain
Cystitis, Interstitial · dysmenorrhea · Migraine Disorders · Pelvic Pain
Source: ClinicalTrials.gov NCT02214550 ↗
Enrolled (actual)
353
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Change in Participant Bladder Pain Sensitivity From Baseline. — 38.2; 37.0; 41.2; 47.9 score on a scale — p=.02
◆ Published Evidence
Emerging
8citations · ~3 / year
Multimodal hypersensitivity derived from quantitative sensory testing predicts pelvic pain outcome: an observational cohort study.
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.
Linked Publications
-
Multimodal hypersensitivity derived from quantitative sensory testing predicts pelvic pain outcome: an observational cohort study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Participant Bladder Pain Sensitivity From Baseline. |
38.2; 37.0; 41.2; 47.9; 2.2; 17.3 | .02 sig |
| SECONDARY Change in Quantitative Sensory Testing (QST) Parameters Regarding Pelvic Hyperalgesia From Baseline |
5.95; 9.38; 13.8; 8.21; 11.6; 6.9 | 0.2315 |
| SECONDARY Differences in EEG Recorded Cortical Activity Among Participants |
10.03; 10.0; 10.05; 10.13; 10.03; 10.15 | .393 |
Eligibility 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 sensory testing study visit.
Data sourced from ClinicalTrials.gov (NCT02214550) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.