DysmenorrheaPhase 4NCT05900336
Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea
A Phase 4 study testing Sodium Naproxen in people with Dysmenorrhea and Menstrual Pain, run by Mclean Hospital at 1 site in United States.
Trial summary
Menstrual pain is the most common gynecological complaint and the leading cause of school and work absences in reproductive-age girls and women. One of the primary treatments for menstrual pain is use of nonsteroidal anti-inflammatory drugs (NSAIDs; over-the-counter medications such as naproxen, ibuprofen, or… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea, Menstrual Pain, Non-steroidal Anti-inflammatory Drug
- What is being tested?
- Sodium Naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2024to 1 Aug 2025
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female aged 18-50 years
- Menstrual pain rated at least 6/10 on a 0 (no pain) to 10 (worst pain possible) NRS for all menstrual cycles in the previous 6 months
- Regular menstrual cycles over the past year (at least 9 in the previous 12 months)
- Self-reported menstrual cycle averaging 22-35 days
- Access to a smartphone and email, and willing/able to receive text messages
- Able to read and understand English
- Ability and willingness to provide written informed consent.
Who cannot join
- Use of oral contraceptives or any exogenous hormones in the previous 3 months prior to participation
- Variable levels of menstrual pain in the previous 6 months
- Self-reported symptoms consistent with a chronic pain condition (e.g., pain in any body area lasting longer than 3 months) or previous diagnosis of a chronic pain condition
- Currently pregnant or breastfeeding
- History of pelvic inflammatory disease or sexually transmitted disease
- Acute illness or injury that would potentially impact pain task performance (e.g., fever, flu symptoms) or that affect sensitivity of the extremities (e.g., Reynaud's disease)
- Allergy to naproxen or having a health condition that contradicts use of naproxen or affects naproxen metabolism (e.g., kidney disease)
- History of high blood pressure or anemia (due to possible complications from NSAID use).
Trial locations and contacts
1 site in 1 country.
About this study
Menstrual pain is the most common gynecological complaint and the leading cause of school and work absences in reproductive-age girls and women. One of the primary treatments for menstrual pain is use of nonsteroidal anti-inflammatory drugs (NSAIDs; over-the-counter medications such as naproxen, ibuprofen, or aspirin), although up to 18% of women do not get pain relief from these medications. One reason for this may be due to central sensitization of pain, which is when alterations in the central nervous system change how pain is processed in the brain and experienced. Determining the role of central sensitization in menstrual pain is important because central sensitization is associated with the development of chronic pain. Understanding the relationship between NSAID response and central sensitization is important because it could indicate women who may go on to develop chronic pain later in life. This study would directly address this question. Identifying women at risk for chronic pain would help target new treatments to this vulnerable group to ideally prevent pain from becoming chronic. This is particularly important for women in the military because the severity of menstrual pain is associated with missed work, such that in active-duty military women, less than 4.4% with mild menstrual pain missed work, whereas 20.7% of women with moderate to severe menstrual pain missed work. Addressing the significant impact of menstrual pain for military women will help reducing suffering and potentially decrease the risk of developing future chronic pain problems in this population.
- Being tested
- Sodium Naproxen, Placebo
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium NaproxenDrug
One dose of 550mg sodium naproxen taken at the onset of at least moderate pain after menstrual bleeding has started (i.e., at least 6/10 on the 0-10 numeric rating scale).
PlaceboDrug
One dose of placebo capsule taken at the onset of at least moderate pain after menstrual bleeding has started (i.e., at least 6/10 on the 0-10 numeric rating scale).
| Study group | Role | What they receive |
|---|---|---|
| Sodium Naproxen first | Experimental | Participants take the dose of sodium naproxen during the first menstrual cycle and take the placebo during the second menstrual cycle. Receives: Drug: Sodium Naproxen; Drug: Placebo |
| Placebo first | Experimental | Participants take the dose of placebo during the first menstrual cycle and take the sodium naproxen during the second menstrual cycle. Receives: Drug: Sodium Naproxen; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Non-steroidal Anti-inflammatory Drug (NSAID) Response
NSAID response will be calculated by comparing change in menstrual pain ratings following NSAID to change in menstrual pain ratings following placebo. Calculated by subtracting the placebo cycle response measure from the NSAID cycle response measure. This will result in a single measure indicative of the degree of NSAID response, while controlling for placebo effects. Possible range: -20 (min) to 20 (max). The value of each intervention separately can be associated with a better or worse outcome, as indicated below. The value of this measure is not independently clinically meaningful (i.e., not related to better or worse outcomes) as it is the result of comparing an individual to themself. Negative values indicate that the participant demonstrated more response to naproxen than they did to placebo; positive values indicate that the participant demonstrated more response to placebo than they did to naproxen.
Measured: 4 hrs after taking dose during the 2nd medicated menstrual period (i.e., 4 hrs after the first occurrence of pain >= 6 on the 0-10 scale after menstrual bleeding has started during the 2nd medicated menstrual period); # of days varies by participant
Urinary Naproxen Concentration
Concentration of naproxen measured in the urine sample. Measured in nanograms of Naproxen Glucuronide per mg creatinine. Value is not independently clinically meaningful (i.e., not related to better or worse outcomes).
Measured: Four hours after taking the dose (either Naproxen or placebo).
Secondary outcomes (4)
Placebo Cycle Response
Change in menstrual pain rating on a 0 (no pain) to 10 (worst pain possible) numeric rating scale before and after the dose is taken. Calculated by subtracting the pre-dose rating from the post-dose rating. Possible range: -10 (min) to 10 (max). Lower scores indicate better outcome.
Measured: 4 hours after dose is taken.
Non-steroidal Anti-inflammatory Drug (NSAID) Cycle Response
Change in menstrual pain rating on a 0 (no pain) to 10 (worst pain possible) numeric rating scale before and after the dose is taken. Calculated by subtracting the pre-dose rating from the post-dose rating. Possible range: -10 (min) to 10 (max). Lower scores indicate better outcome.
Measured: 4 hours after dose is taken.
Urinary PGF2α Concentration
Concentration of prostaglandin F2α (PGF2α) measured in the urine sample. Value is not independently clinically meaningful (i.e., not related to better or worse outcomes).
Measured: Four hours after taking the dose (either Naproxen or placebo).
Urinary PGE Concentration
New information since initial submission indicated that this outcome measure (Prostaglandin E; PGE) would not be detectable in urine. No PGE analyses were conducted.
Measured: Four hours after taking the dose (either Naproxen or placebo).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start25 Mar 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Endeavor Health
- Responsible party
- Principal investigator, Laura Payne, Mclean Hospital
- Investigators
- Laura Payne, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900336
- Sponsor's protocol ID
- 2023P001489
- Status last verified
- Aug 2026
- First submitted
- 31 May 2023
- Last updated
- 22 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05900336
- Acronym / sponsor ID
- 2023P001489
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- United States Department of Defense, Endeavor Health
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Posted 22 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Menstrual pain is the most common gynecological complaint and the leading cause of school and work absences in reproductive-age girls and women. One of the primary treatments for menstrual pain is use of nonsteroidal anti-inflammatory drugs (NSAIDs; over-the-counter medications such as naproxen, ibuprofen, or aspirin), although up to 18% of women do not get pain relief from these medications. One reason for this may be due to central sensitization of pain, which is when alterations in the central nervous system change how pain is processed in the brain and experienced. Determining the role of central sensitization in menstrual pain is important because central sensitization is associated with the development of chronic pain. Understanding the relationship between NSAID response and central sensitization is important because it could indicate women who may go on to develop chronic pain later in life. This study would directly address this question. Identifying women at risk for chronic pain would help target new treatments to this vulnerable group to ideally prevent pain from becoming chronic. This is particularly important for women in the military because the severity of menstrual pain is associated with missed work, such that in active-duty military women, less than 4.4% with mild menstrual pain missed work, whereas 20.7% of women with moderate to severe menstrual pain missed work. Addressing the significant impact of menstrual pain for military women will help reducing suffering and potentially decrease the risk of developing future chronic pain problems in this population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Naproxen first | Experimental | Drug: Sodium Naproxen, Drug: PlaceboParticipants take the dose of sodium naproxen during the first menstrual cycle and take the placebo during the second menstrual cycle. |
| Placebo first | Experimental | Drug: Sodium Naproxen, Drug: PlaceboParticipants take the dose of placebo during the first menstrual cycle and take the sodium naproxen during the second menstrual cycle. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female aged 18-50 years
- Menstrual pain rated at least 6/10 on a 0 (no pain) to 10 (worst pain possible) NRS for all menstrual cycles in the previous 6 months
- Regular menstrual cycles over the past year (at least 9 in the previous 12 months)
- Self-reported menstrual cycle averaging 22-35 days
- Access to a smartphone and email, and willing/able to receive text messages
Key exclusion criteria (8 listed)
- Use of oral contraceptives or any exogenous hormones in the previous 3 months prior to participation
- Variable levels of menstrual pain in the previous 6 months
- Self-reported symptoms consistent with a chronic pain condition (e.g., pain in any body area lasting longer than 3 months) or previous diagnosis of a chronic pain condition
- Currently pregnant or breastfeeding
- History of pelvic inflammatory disease or sexually transmitted disease
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 |
|---|---|---|
| Sodium NaproxenOne dose of 550mg sodium naproxen taken at the onset of at least moderate pain after menstrual bleeding has started (i.e., at least 6/10 on the 0-10 numeric rating scale). | Drug | Placebo first, Sodium Naproxen first |
| PlaceboOne dose of placebo capsule taken at the onset of at least moderate pain after menstrual bleeding has started (i.e., at least 6/10 on the 0-10 numeric rating scale). | Drug | Placebo first, Sodium Naproxen first |
Primary outcome
Overall Non-steroidal Anti-inflammatory Drug (NSAID) Response
Time frame: 4 hrs after taking dose during the 2nd medicated menstrual period (i.e., 4 hrs after the first occurrence of pain >= 6 on the 0-10 scale after menstrual bleeding has started during the 2nd medicated menstrual period); # of days varies by participant
NSAID response will be calculated by comparing change in menstrual pain ratings following NSAID to change in menstrual pain ratings following placebo. Calculated by subtracting the placebo cycle response measure from the NSAID cycle response measure. This will result in a single measure indicative of the degree of NSAID response, while controlling for placebo effects. Possible range: -20 (min) to 20 (max). The value of each intervention separately can be associated with a better or worse outcome, as indicated below. The value of this measure is not independently clinically meaningful (i.e., not related to better or worse outcomes) as it is the result of comparing an individual to themself. Negative values indicate that the participant demonstrated more response to naproxen than they did to placebo; positive values indicate that the participant demonstrated more response to placebo than they did to naproxen.
Urinary Naproxen Concentration
Time frame: Four hours after taking the dose (either Naproxen or placebo).
Concentration of naproxen measured in the urine sample. Measured in nanograms of Naproxen Glucuronide per mg creatinine. Value is not independently clinically meaningful (i.e., not related to better or worse outcomes).
4 secondary outcomes
Placebo Cycle Response
Time frame: 4 hours after dose is taken.
Non-steroidal Anti-inflammatory Drug (NSAID) Cycle Response
Time frame: 4 hours after dose is taken.
Urinary PGF2α Concentration
Time frame: Four hours after taking the dose (either Naproxen or placebo).
Urinary PGE Concentration
Time frame: Four hours after taking the dose (either Naproxen or placebo).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Laura Payne, PhD principal investigator
Mclean Hospital
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 Sodium Naproxen in people with Dysmenorrhea and Menstrual Pain, run by Mclean Hospital 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 7 inclusion and 8 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 22 Sep 2026. 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 22 Sep 2026). 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?
Overall Non-steroidal Anti-inflammatory Drug (NSAID) Response (time frame: 4 hrs after taking dose during the 2nd medicated menstrual period (i.e., 4 hrs after the first occurrence of pain >= 6 on the 0-10 scale after menstrual bleeding has started during the 2nd medicated menstrual period); # of days varies by participant). 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?
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 22 Sep 2026.