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The goal of this study is to see if optimized use of naproxen for treatment of dysmenorrhea will improve pain report from baseline. In addition, we will determine whether cross-organ influences from the uterus on bladder pain sensitivity change from baseline after reduced menstrual pain experience over six months. Finally, a battery of quantitative sensory tests and EEG measures of sensory sensitivity will be used to evaluate mechanisms associated with improvements in menstrual and bladder pain.
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 experience chronic pelvic pain (CPP) which may be in part due to cross-organ neural sensitization.
In this study we will establish whether prophylactic and adequate dosages of naproxen are capable of reducing menstrual pain more than *** use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Dysmenorrhea | Experimental | We will look at the effects of naproxen 500mg use on pain starting just before and during menses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen | Drug | Participants will take naproxen 500mg BID before and for the first 3 days of their period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Menstrual Pain | Score on a scale. Specifically, we used a Numeric Rating Scale (NRS)- 0 through 10 scale with 0 being no pain and 10 worst pain imaginable. Results for the worst menstrual pain score on an NRS from the 6-8 mth menstrual pain diary will be compared to baseline pretreatment diary worst pain score. | 6-8 months |
| Change in Participant Bladder Pain Sensitivity From Baseline | Score on a scale. Specifically, we used a Visual Analog Scale- 0 through 100 scale with 0 being no pain and 100 worst pain imaginable. Results from the visual analog scale (VAS) of the bladder filling test at the baseline and 6-8 mph followup visit will be compared to determine if naproxen treatment of menstrual pain affected bladder pain. Bladder pain ratings at first urge will be used at the outcome measure. | 6-8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Tu, MD, MPH | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7011011 | Background | Chan WY, Dawood MY, Fuchs F. Prostaglandins in primary dysmenorrhea. Comparison of prophylactic and nonprophylactic treatment with ibuprofen and use of oral contraceptives. Am J Med. 1981 Mar;70(3):535-41. doi: 10.1016/0002-9343(81)90576-3. | |
| 28888592 | Background | Oladosu FA, Tu FF, Hellman KM. Nonsteroidal antiinflammatory drug resistance in dysmenorrhea: epidemiology, causes, and treatment. Am J Obstet Gynecol. 2018 Apr;218(4):390-400. doi: 10.1016/j.ajog.2017.08.108. Epub 2017 Sep 6. |
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Participants were recruited between April 2018 and December 2019 from our registry and other studies.
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary Dysmenorrhea | We will look at the effects of naproxen 500mg use on pain starting just before and during menses. Naproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Dysmenorrhea | We will look at the effects of naproxen 500mg use on pain starting just before and during menses. Naproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Menstrual Pain | Score on a scale. Specifically, we used a Numeric Rating Scale (NRS)- 0 through 10 scale with 0 being no pain and 10 worst pain imaginable. Results for the worst menstrual pain score on an NRS from the 6-8 mth menstrual pain diary will be compared to baseline pretreatment diary worst pain score. | Some participant data were missing due to attrition | Posted | Mean | Standard Deviation | score on a scale | 6-8 months |
|
6 months
Participants were asked to verbally relay any AEs they had experienced during the trial at follow-up. Please note, all-cause mortality or serious & other AEs were not formally queried, but we did monitor for them.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary Dysmenorrhea | We will look at the effects of naproxen 500mg use on pain starting just before and during menses. Naproxen: Participants will take naproxen 500mg BID before and for the first 3 days of their period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia grade 1 | Gastrointestinal disorders | CTAE version 5 | Non-systematic Assessment | Nausea, upset stomach (mild, grade 1). Mild symptoms; intervention not indicated. Maybe unrelated to study drug as another new drug was being started at the same time. |
There was some loss to follow-up. We did not systematically query for adverse events.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Hellman, Research Associate Professor | NorthShore University HealthSystem | 847-570-2622 | khellman@northshore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2018 | May 8, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 31, 2018 | May 8, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D010146 | Pain |
| D059265 | Visceral Pain |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| 31870730 | Background | Tu FF, Datta A, Atashroo D, Senapati S, Roth G, Clauw DJ, Hellman KM. Clinical profile of comorbid dysmenorrhea and bladder sensitivity: a cross-sectional analysis. Am J Obstet Gynecol. 2020 Jun;222(6):594.e1-594.e11. doi: 10.1016/j.ajog.2019.12.010. Epub 2019 Dec 20. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Menstrual Pain | Numeric Rating Scale is a 0-10 scale with 0 being no pain and 10 being the worst imaginable. Results from the NRS for worst day's menstrual pain are reported | Mean | Standard Deviation | Numerical rating scale |
|
| Bladder Pain | Visual analog scale is a 0-100 scale with 0 being no pain and 100 worst pain imaginable. Results from the VAS of the bladder filling test are compared to determine if participants had a reduction in pain following treatment. Bladder pain ratings at first urge are used as the outcome measure. | 3 participants did not complete baseline visits to measure bladder pain | Mean | Standard Deviation | Visual Analog Scale 0-100 |
|
| Units | Counts |
|---|
| Participants |
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|
|
| Primary | Change in Participant Bladder Pain Sensitivity From Baseline | Score on a scale. Specifically, we used a Visual Analog Scale- 0 through 100 scale with 0 being no pain and 100 worst pain imaginable. Results from the visual analog scale (VAS) of the bladder filling test at the baseline and 6-8 mph followup visit will be compared to determine if naproxen treatment of menstrual pain affected bladder pain. Bladder pain ratings at first urge will be used at the outcome measure. | Some participant data were missing due to attrition. | Posted | Mean | Standard Deviation | score on a scale | 6-8 months |
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| 0 |
| 26 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D059226 | Nociceptive Pain |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |