DysmenorrheaPhase 4NCT03697720

Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain

A Phase 4 study testing Naproxen in people with Dysmenorrhea and Pain, run by Endeavor Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Dysmenorrhea, Pain
What is being tested?: Naproxen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 9 May 2018to 27 Sep 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

Reproductive-age women (age 18-45) with dysmenorrhea
Average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) on at least one day during menses or during withdrawal uterine bleeding from cyclic OCs without painkillers
Menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament
Indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCPs)

Who cannot join

Presence of active pelvic or abdominal malignancies (primary or metastatic)
Absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding)
Active genitourinary infection in the last four weeks
Unable to read or comprehend the informed consent in English
Unwilling to complete study procedures
Presence of hypertension or risk for developing hypertension

Show all 9Show fewer

Unwillingness to take naproxen and/or placebo
Contradictions to taking naproxen (allergies, kidney disease, anemia, alcoholism, cardiovascular disease, stomach or intestinal ulcer or abnormal liver function)
Formal urological diagnosis such as overactive bladder or bladder pain syndrome.

Trial locations and contacts

1 site in 1 country.

United States1 site

NorthShore University Health System
Evanston, Illinois, 60201

Other trials in United States

About this study

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.

Read the 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 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.

Conditions: Dysmenorrhea, Pain
Being tested: Naproxen
Keywords: cross-organ sensitivity, bladder pain, NSAID, visceral pain
Medical subject headings: Dysmenorrhea, Pain, Visceral Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NaproxenDrug
Participants will take naproxen 500mg BID before and for the first 3 days of their period.

Study groups in NCT03697720
Study group	Role	What they receive
Primary Dysmenorrhea	Experimental	We will look at the effects of naproxen 500mg use on pain starting just before and during menses. Receives: Drug: Naproxen

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 6-8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 201827 Sep 2023

First posted5 Oct 2018
Study start9 May 2018
Primary completion23 Nov 2020
Study completion27 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for DysmenorrheaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03697720
Sponsor's protocol ID: EH18-128
Status last verified: Sep 2023
First submitted: 4 Oct 2018
Last updated: 18 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 7011011
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.
PubMed 28888592
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.
PubMed 31870730

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Effect of a Ginger Formula on Menstrual Health vs a Placebo
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All Dysmenorrhea trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Examining the Role of Improved NSAID Management in Treating Dysmenorrhea and Bladder Pain
ClinicalTrials.gov ID: NCT03697720
Acronym / sponsor ID: EH18-128
Conditions: Dysmenorrhea, Pain
Keywords: cross-organ sensitivity, bladder pain, NSAID, visceral pain
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Endeavor HealthUniversity, hospital or other
Study start: 9 May 2018 (actual)
Primary completion: 23 Nov 2020 (actual)
Study completion: 27 Sep 2023 (actual)
First posted: 5 Oct 2018 (actual)
Results: Posted 18 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In this study we will establish whether prophylactic and adequate dosages of naproxen are capable of reducing menstrual pain more than *** use.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Primary Dysmenorrhea	Experimental	Drug: NaproxenWe will look at the effects of naproxen 500mg use on pain starting just before and during menses.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Reproductive-age women (age 18-45) with dysmenorrhea
Average menstrual pain ≥ 5/10 (0=no pain and 10=the worst imaginable pain) on at least one day during menses or during withdrawal uterine bleeding from cyclic OCs without painkillers
Menstrual pain in the region between the umbilicus and the perineum, above the level of the inguinal ligament
Indication the participant has attempted to resolve pain by medical means (including NSAIDs and/or OCPs)

Key exclusion criteria (9 listed)

Presence of active pelvic or abdominal malignancies (primary or metastatic)
Absence of regular menses (including current pregnancy, recent pregnancy, or active breast feeding)
Active genitourinary infection in the last four weeks
Unable to read or comprehend the informed consent in English
Unwilling to complete study procedures

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NaproxenParticipants will take naproxen 500mg BID before and for the first 3 days of their period.	Drug	Primary Dysmenorrhea

Primary outcome

Change in Menstrual Pain
Time frame: 6-8 months
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.
Change in Participant Bladder Pain Sensitivity From Baseline
Time frame: 6-8 months
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.

Results and safety

Results posted to the registry on 18 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Dysmenorrhea	26	19

Primary outcome: Change in Menstrual Pain

Time frame: 6-8 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Primary Dysmenorrhea n = 19
Value	4.1 (2.4)

Primary Dysmenorrhea: p <0.0001, t-test, 2 sided

Population analysed: Some participant data were missing due to attrition

Primary outcome: Change in Participant Bladder Pain Sensitivity From Baseline

Time frame: 6-8 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Primary Dysmenorrhea n = 17
Value	10.7 (10.6)

Primary Dysmenorrhea: p = .119, t-test, 2 sided

Population analysed: Some participant data were missing due to attrition.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Dysmenorrhea	0 of 26 (0%)	1 of 26 (3.8%)	0 of 26

Limitations and caveats (from the sponsor): There was some loss to follow-up. We did not systematically query for adverse events.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 7011011Chan 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.
Background: PubMed 28888592Oladosu 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.
Background: PubMed 31870730Tu 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.
Individual participant dataSharing planned: No

Related trials for Dysmenorrhea

Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Frank Tu, MD, MPH principal investigator

Endeavor Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Naproxen in people with Dysmenorrhea and Pain, run by Endeavor Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Menstrual Pain (time frame: 6-8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03697720, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.