Chronic Pain Risk Associated With Menstrual Period Pain
Condition: Cystitis, Interstitial; Dysmenorrhea; Migraine Disorders; Pelvic Pain; Endometriosis; Visceral Pain; Chronic Pain
MeSH terms: Migraine Disorders; Endometriosis; Cystitis; Cystitis, Interstitial; Chronic Pain; Pelvic Pain; Dysmenorrhea; Visceral Pain
Study type: Interventional
Phase: Phase 4

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.
    

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 women. One out of every five of those women in turn will develop chronic
      pelvic pain (CPP), yet women without dysmenorrhea rarely report CPP. CPP disorders such as
      irritable bowel syndrome (IBS) and painful bladder syndrome (PBS) can cause severe,
      unrelenting pain due to a lack of effective treatments.

      This study consists of 2 aims.

      Aim #1: To determine if dysmenorrhea with concomitant bladder pain sensitivity exhibits
      neurophysiological features consistent with established CPP. Women with chronic pain or
      dysmenorrhea without COS will be used as controls. Quantitative sensory testing (QST) and a
      noninvasive bladder pain test that investigators validated previously be used to determine
      whether impairments in descending inhibition and pelvic sensitivity are responsible for
      vulnerability to COS in women with dysmenorrhea. EEG will be recorded to look for differences
      in brain activity in response to sensory stimulation between participants cohorts.

      Aim #2: To differentiate the individual contributions of circulating sex hormones and
      repeated sensitizing events (painful menses) on descending and peripheral mechanisms of
      bladder pain. The same QST/bladder pain measures studied in Aim #1 will be retested within
      the dysmenorrhea+COS group following a one-year randomized trial of cyclical OCs vs.
      continuous OCs vs. no treatment. An observational arm of PBS participants will receive
      continuous OCs and serve as controls.
    

Intervention name(s): cyclic microgestin 1/20; continuous microgestin 1/20
Intervention type(s): Drug; Drug
Intervention description(s): 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; Continuous OC use - Pills containing hormones will be taken every day for 1 year
Other intervention name(s): loestrin 1/20; loestrin 1/20
Intervention MeSH terms: Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Norinyl; Mestranol; Norethindrone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Cystitis, Interstitial; Dysmenorrhea; Migraine Disorders; Cross Organ Sensitization; Pelvic Pain; Endometriosis; Contraceptives, Oral; Birth Control Pills; Painful Bladder Syndrome; Visceral Pain; Chronic Pain