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Chronic Pain Risk Associated With Menstrual Period Pain (CRAMPP)

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ClinicalTrials.gov Identifier: NCT02214550
Recruitment Status : Recruiting
First Posted : August 12, 2014
Last Update Posted : February 2, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Frank F. Tu, NorthShore University HealthSystem Research Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Cystitis, Interstitial Dysmenorrhea Migraine Disorders Pelvic Pain Endometriosis Visceral Pain Chronic Pain Drug: microgestin 1/20 Phase 4

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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Deciphering the Hormonal and Nociceptive Mechanisms Underlying Bladder Pain
Study Start Date : July 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Pain Discovery Aim

255 Reproductive age women (18-45) will be identified and divided into 5 groups

  1. Healthy Controls
  2. Chronic Pain (Positive Controls)
  3. Dysmenorrhea (D)
  4. Dysmenorrhea with Cross Organ Sensitization (D+COS)
  5. Painful bladder syndrome (PBS)/interstitial cystitis (IC)

After a screening, dysmenorrhea with COS and PBS participants will be compared with controls. Daily Diaries will be completed for 1-3 months. During the luteal phase of the participants' menstrual cycle or a predetermined time, participants will complete aim #1 testing consisting of a battery of questionnaires, bladder sensitivity testing, quantitative sensory testing (QST), a blood draw and EEG testing. All participants will also complete a yearly follow-up questionnaire for 5 years.

No Intervention: D+COS-no OC
For Aim #2, ten participants in the Dysmenorrhea + COS group will not receive an OC intervention. Monthly questionnaires will be completed for 1 yr. Aim #1 testing will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
Active Comparator: D+COS-cyclic microgestin 1/20
For Aim #2, 26 participants in the Dysmenorrhea + COS group will receive cyclic OC. Monthly questionnaires will be completed for 1 yr. Aim #1 testing will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
Drug: 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

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

Other Name: loestrin 1/20

Active Comparator: D+COS-continuous microgestin 1/20
For Aim #2, 26 participants in the Dysmenorrhea + COS group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. Aim #1 testing will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
Drug: 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

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

Other Name: loestrin 1/20

Active Comparator: PBS-continuous microgestin 1/20
For Aim #2, 26 participants in the Painful Bladder Syndrome group will receive continuous OC. Monthly questionnaires will be completed for 1 yr. Aim #1 testing will be repeated at 6 months and 12 months. A yearly follow-up questionnaire will be completed for 5 years.
Drug: 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

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

Other Name: loestrin 1/20




Primary Outcome Measures :
  1. Change in participant bladder pain sensitivity from baseline. [ Time Frame: 6 month and 12 month visits ]
    Results from the visual analog scale (VAS) of the bladder filling test at the initial, 6 month and 12 month visits will be compared to determine if participants in each of the treatment groups had a reduction in pain.


Secondary Outcome Measures :
  1. Change in Quantitative Sensory Testing (QST) parameters regarding pelvic hyperalgesia from baseline [ Time Frame: 6 months and 12 months ]
    Results from the QST testing performed at initial, 6 month and 12 month visits will be compared to determine if participants in each of the treatment groups had a reduction in sensitivity from baseline

  2. Differences in EEG recorded cortical activity among participants [ Time Frame: Baseline, 6 months and 12 months ]
    Results from EEG site specific ERPs and brainwave related variables performed at Baseline, 6 month, and 12 Month to determine whether differences in brain activity are responsible for sensitivity.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 Aim #1 study visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214550


Contacts
Contact: Nicole Steiner 847-570-2622 pelvicpainresearch@northshore.org
Contact: Frank Tu, MD, MPH 847-570-2521 ftu@northshore.org

Locations
United States, Illinois
NorthShore University Health System Recruiting
Evanston, Illinois, United States, 60201
Principal Investigator: Frank Tu, MD, MPH         
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Frank Tu, MD, MPH NorthShore University HealthSystem Research Institute

Additional Information:
Publications:
Responsible Party: Frank F. Tu, Division Director, Gynecological Pain and Minimally Invasive Surgery, Department of Obstetrics and Gynecology, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT02214550     History of Changes
Other Study ID Numbers: EH13-094
1R01DK100368-01 ( U.S. NIH Grant/Contract )
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Frank F. Tu, NorthShore University HealthSystem Research Institute:
Cystitis, Interstitial
Dysmenorrhea
Migraine Disorders
Cross Organ Sensitization
Pelvic Pain
Endometriosis
Contraceptives, Oral
Birth Control Pills
Painful Bladder Syndrome
Visceral Pain
Chronic Pain

Additional relevant MeSH terms:
Migraine Disorders
Chronic Pain
Endometriosis
Pelvic Pain
Cystitis
Dysmenorrhea
Visceral Pain
Cystitis, Interstitial
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Genital Diseases, Female
Urinary Bladder Diseases
Urologic Diseases
Menstruation Disturbances
Pathologic Processes
Nociceptive Pain