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Why do period pills fail some women? new study investigates

NCT ID NCT05900336

Knowledge-focused Sponsor: Mclean Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 70 women with severe menstrual pain to understand why some don't get relief from NSAIDs like naproxen. Researchers measured pain changes after taking the drug or a placebo and tested how the brain processes pain. The goal is to find out if central sensitization—changes in how the nervous system handles pain—explains why some women don't respond to standard treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sodium naproxen
What this could lead to
If successful, this could help identify women at risk for chronic pain and guide early treatments to prevent it.
What could go wrong
This is a small, completed Phase 4 study focused on understanding pain mechanisms, not testing a new treatment. Results may not apply to all women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

70 people

The number who actually took part.

Started

Mar 2024

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female aged 18-50 years 2. 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 3. Regular menstrual cycles over the past year (at least 9 in the previous 12 months) 4. Self-reported menstrual cycle averaging 22-35 days 5. Access to a smartphone and email, and willing/able to receive text messages 6. Able to read and understand English 7. Ability and willingness to provide written informed consent. Exclusion Criteria: 1. Use of oral contraceptives or any exogenous hormones in the previous 3 months prior to participation 2. Variable levels of menstrual pain in the previous 6 months 3. 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 4. Currently pregnant or breastfeeding 5. History of pelvic inflammatory disease or sexually transmitted disease 6. 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) 7. Allergy to naproxen or having a health condition that contradicts use of naproxen or affects naproxen metabolism (e.g., kidney disease) 8. History of high blood pressure or anemia (due to possible complications from NSAID use).

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Conditions

The condition(s) this trial relates to.

dysmenorrhea

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dysmenorrhea Menstrual pain Non-steroidal anti-inflammatory drug

Contacts and locations

Locations

  • McLean Hospital

    Belmont, Massachusetts, 02478, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.