CompletedPhase 4

Chronic Pain Risk Associated With Menstrual Period Pain

United States353 participantsStarted 2014-07

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Participant Bladder Pain Sensitivity From Baseline.

Timeframe: 0 (baseline), 6 month, and 12 month visits

Trial details

NCT IDNCT02214550

SponsorEndeavor Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11

Results submitted2022-07-20

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