DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Chronic Pain Risk Associated With Menstrual Period Pain

Information source: NorthShore University HealthSystem Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystitis, Interstitial; Dysmenorrhea; Migraine Disorders; Pelvic Pain; Endometriosis; Visceral Pain

Intervention: microgestin 1/20 (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: NorthShore University HealthSystem Research Institute

Official(s) and/or principal investigator(s):
Frank Tu, MD, MPH, Principal Investigator, Affiliation: NorthShore University HealthSystem Research Institute

Overall contact:
Julia Kane, MA, CCRP, Phone: 847-570-2622, Email: jkane@northshore.org


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. We 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.

Clinical Details

Official title: Deciphering the Hormonal and Nociceptive Mechanisms Underlying Bladder Pain

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Change in participant bladder pain sensitivity from baseline.

Secondary outcome: Change in Quantitative Sensory Testing (QST) parameters regarding pelvic hyperalgesia from baseline

Detailed description: Endometrial shedding during the menstrual cycle elicits profound changes in neuronal activity and cytokines 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 migraines or dysmenorrhea without COS will be used as controls. Quantitative sensory testing (QST) and a noninvasive bladder pain test we previously have validated will be used to determine whether impairments in descending inhibition and pelvic sensitivity are responsible for vulnerability to COS in women with dysmenorrhea. 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 patients will receive continuous OCs and serve as controls.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.


Inclusion Criteria:

- Reproductive age women (18-45) with dysmenorrhea, migraine (without aura) or painful

bladder syndrome

- Subjects must have had regular (22-45 day) menstrual cycles over at least a two month

period preceding testing Exclusion Criteria:

- presence of active pelvic or abdominal malignancies (primary or metastatic),

- absence of regular menses (including current pregnancy, recent pregnancy, or active

breast feeding) unwilling to take either cyclic or combined OCs,

- 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

- unwilling to withdraw from OCs for two months prior to the Aim #1 study visit.

Locations and Contacts

Julia Kane, MA, CCRP, Phone: 847-570-2622, Email: jkane@northshore.org

NorthShore University Health System, Evanston, Illinois 60201, United States; Recruiting
Frank Tu, MD, MPH, Principal Investigator
Additional Information

Click here for more information about this study: CRAMPP

Related publications:

Tu FF, Epstein AE, Pozolo KE, Sexton DL, Melnyk AI, Hellman KM. A noninvasive bladder sensory test supports a role for dysmenorrhea increasing bladder noxious mechanosensitivity. Clin J Pain. 2013 Oct;29(10):883-90. doi: 10.1097/AJP.0b013e31827a71a3.

Tu FF, Fitzgerald CM, Kuiken T, Farrell T, Norman Harden R. Vaginal pressure-pain thresholds: initial validation and reliability assessment in healthy women. Clin J Pain. 2008 Jan;24(1):45-50. doi: 10.1097/AJP.0b013e318156db13.

Zondervan KT, Yudkin PL, Vessey MP, Jenkinson CP, Dawes MG, Barlow DH, Kennedy SH. Chronic pelvic pain in the community--symptoms, investigations, and diagnoses. Am J Obstet Gynecol. 2001 May;184(6):1149-55.

Westling AM, Tu FF, Griffith JW, Hellman KM. The association of dysmenorrhea with noncyclic pelvic pain accounting for psychological factors. Am J Obstet Gynecol. 2013 Nov;209(5):422.e1-422.e10. doi: 10.1016/j.ajog.2013.08.020. Epub 2013 Aug 22.

Starting date: July 2014
Last updated: August 8, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017