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Chronic Pain Risk Associated With Menstrual Period Pain

NCT02214550 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2023-06-18

Study results available
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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.

Conditions

  • Cystitis, Interstitial
  • Dysmenorrhea
  • Migraine Disorders
  • Pelvic Pain
  • Endometriosis
  • Visceral Pain
  • Chronic Pain

Interventions

DRUG

cyclic microgestin 1/20

Cyclic OC Use - Participants will ingest pills containing active hormones for 21 days followed by 7 days of no pills, and then the cycle will repeat

DRUG

continuous microgestin 1/20

Continuous OC use - Pills containing hormones will be taken every day for 1 year

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Endeavor Health

    lead OTHER

Principal Investigators

  • Frank Tu, MD, MPH · Endeavor Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2020-11-30
Completion
2021-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02214550 on ClinicalTrials.gov