NCT02214550

Chronic Pain Risk Associated With Menstrual Period Pain

Deciphering the Hormonal and Nociceptive Mechanisms Underlying Bladder Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-07-01
• Primary completion: 2020-11-01
• Completion: 2021-01-01
• First posted: 2014-08-12
• Last updated: 2023-06-18
• Results posted: 2023-06-18

Locations

1 site across 1 country: United States