NSAIDs for Menstrual Pain

Overseen By Laura Payne, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Mclean Hospital

Must not be taking: Oral contraceptives, Exogenous hormones

Disqualifiers: Chronic pain, Pregnancy, Pelvic inflammatory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of sodium naproxen, a type of NSAID (nonsteroidal anti-inflammatory drug), for menstrual pain relief. Researchers aim to understand why some women do not find relief from NSAIDs, such as ibuprofen, and explore the role of central sensitization—a change in how the brain processes pain that might lead to chronic pain. Participants will take either naproxen or a placebo (inactive pill) during different menstrual cycles to determine any differences in pain relief. Women who experience severe menstrual pain that disrupts daily life and have regular periods may be suitable for this trial. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used oral contraceptives or any hormones in the past 3 months.

What is the safety track record for sodium naproxen?

Research shows that sodium naproxen, the treatment under study, is usually well-tolerated for pain relief. Many people use it as a common over-the-counter medicine for menstrual cramps without serious problems. However, like all medicines, it can have side effects. Some individuals might experience stomach pain, nausea, or headaches. In rare cases, it can cause more serious issues like stomach ulcers or bleeding.

This study is in a later stage, indicating that sodium naproxen has already undergone extensive safety testing. The FDA has approved it for other conditions, such as arthritis and muscle aches, suggesting it is safe for most people. Prospective trial participants should consult a doctor, especially if there are concerns about side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about sodium naproxen for menstrual pain because it offers a well-known, effective ingredient tailored for quick relief. Unlike other NSAIDs, such as ibuprofen or aspirin, sodium naproxen is known for its potent anti-inflammatory action and longer-lasting pain relief, which could mean fewer doses throughout the day. Additionally, its effectiveness in targeting the specific inflammatory pathways involved in menstrual cramps makes it a promising option for those seeking reliable pain management.

What is the effectiveness track record for sodium naproxen in treating menstrual pain?

Research has shown that sodium naproxen, which participants in this trial may receive, effectively relieves menstrual pain. Studies have found that this medication eases cramps during painful periods better than acetaminophen, another common pain reliever. Sodium naproxen provides significant pain relief for up to 12 hours. A review of several studies confirmed its effectiveness at over-the-counter doses and its safety. Overall, sodium naproxen is a reliable choice for managing menstrual pain. ^{5 6 7 8 9}

Who Is on the Research Team?

Laura Payne, PhD

Principal Investigator

Mclean Hospital

Are You a Good Fit for This Trial?

This trial is for women aged 18-50 who experience severe menstrual pain, rating it at least a 6 out of 10. They should have had regular menstrual cycles over the past year and be able to use a smartphone and email. Participants must understand English and consent to the study.

Inclusion Criteria

I am a woman aged between 18 and 50.

Regular menstrual cycles over the past year (at least 9 in the previous 12 months)

Ability and willingness to provide written informed consent

Exclusion Criteria

I have had pelvic inflammatory disease or an STD in the past.

I have not used oral contraceptives or any hormones in the last 3 months.

Currently pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including bladder pain tasks and pressure pain sensitivity tests

1 week

1 visit (in-person)

Treatment Cycle 1

Participants take either placebo or sodium naproxen during the first menstrual cycle

4 weeks

1 visit (in-person)

Treatment Cycle 2

Participants take the alternate treatment (sodium naproxen or placebo) during the second menstrual cycle

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sodium Naproxen

Trial Overview The study tests if Sodium Naproxen, an NSAID, can relieve severe menstrual cramps compared to a placebo. It also examines how the central nervous system's response might influence chronic pain development in these women.

How Is the Trial Designed?

Group I: Sodium Naproxen first Experimental Treatment 2 Interventions

Participants take the dose of sodium naproxen during the first menstrual cycle and take the placebo during the second menstrual cycle.

Group II: Placebo first Experimental Treatment 2 Interventions

Participants take the dose of placebo during the first menstrual cycle and take the sodium naproxen during the second menstrual cycle.

Sodium Naproxen is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Naproxen for:

• Pain relief
• Fever reduction
• Inflammation
• Dysmenorrhea

Approved in European Union as Naproxen for:

• Pain relief
• Fever reduction
• Inflammation
• Dysmenorrhea
• Rheumatoid arthritis
• Osteoarthritis

Approved in Canada as Naproxen for:

• Pain relief
• Fever reduction
• Inflammation
• Dysmenorrhea

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

Endeavor Health

Collaborator

Trials

135

Recruited

742,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

NorthShore University HealthSystem

Collaborator

Trials

134

Recruited

740,000+

Published Research Related to This Trial

Naproxen sodium (Anaprox) is an effective anti-inflammatory and pain relief medication, primarily working by inhibiting prostaglandin synthesis, which is linked to relief from menstrual pain (dysmenorrhea).

The drug is rapidly absorbed in its sodium salt form, has a long half-life of about 13 hours, and is mostly excreted unchanged in urine, indicating a straightforward metabolism with a high therapeutic index and minimal significant drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naproxen sodium (Anaprox): pharmacology, pharmacokinetics and drug interactions. Segre, EJ.[2013]

Naproxen and naproxen sodium are effective non-steroidal anti-inflammatory drugs (NSAIDs) with various indications, but they can cause adverse reactions affecting the gastrointestinal tract, central nervous system, kidneys, liver, and blood.

Recent studies raise questions about the safety and recommendations for using these drugs, particularly in vulnerable populations like the elderly and pregnant women, highlighting the need for cautious prescribing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naproxen: pharmacology and dental therapeutics. Roda, RS.[2022]

In a study involving 64 women with primary dysmenorrhea, naproxen sodium was found to be significantly more effective than placebo in reducing pain intensity and allowing women to continue their daily activities during menstrual cycles.

Only one participant experienced side effects from naproxen sodium, indicating that it is a safe option for managing dysmenorrhea, especially since it greatly reduced the number of women who had to stay home due to pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naproxen sodium in dysmenorrhea. Its influence in allowing continuation of work/school activities. Hanson, FW., Izu, A., Henzl, MR.[2013]

In a study involving 35 young women, diclofenac sodium significantly reduced menstrual pain compared to a placebo, with strong statistical support (P < 0.001).

Diclofenac sodium also effectively decreased menstrual bleeding, as shown by both subjective ratings and the number of sanitary pads used, indicating its dual benefit in managing dysmenorrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of primary dysmenorrhea with diclofenac sodium. Riihiluoma, P., Wuolijoki, E., Pulkkinen, MO.[2019]

In a clinical trial involving 20 patients with painful menstrual periods due to endometriosis, naproxen sodium provided complete or substantial pain relief in 83% of cases, compared to only 41% with placebo, demonstrating its efficacy (P = .008).

Naproxen sodium also reduced the need for additional pain relief, with only 5% of treated women requiring supplemental analgesics versus 36% in the placebo group (P = .002), and it was found to be safe with no significant side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naproxen sodium in dysmenorrhea secondary to endometriosis. Kauppila, A., Rönnberg, L.[2013]

Naproxen sodium and naproxen have been shown to be effective analgesics for treating various obstetric and gynecologic pain conditions, including dysmenorrhea, postpartum pain, and pain from gynecologic surgery.

The literature review indicates that these compounds are useful in managing pain and inflammation associated with a wide range of gynecologic issues, highlighting their versatility as pain relief options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naproxen sodium for OB/GYN use, with special reference to pain states: a review. Edgren, RA., Morton, CJ.[2013]

In a double-blind trial involving 32 women with dysmenorrhea, naproxen sodium significantly improved pain relief compared to placebo, with an average relief score of 13.7 versus 8.8 out of 18, indicating its efficacy in treating menstrual pain.

The study reported minimal side effects among participants, suggesting that naproxen sodium is a safe option for managing dysmenorrhea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating dysmenorrhea with anti-inflammatory agents: a double-blind trial with naproxen sodium. Sande, HA., Salvesen, T., Izu, A.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31397597/

a double-blind, randomized, single-dose, crossover study Conclusions: A single, maximum non-prescription dose of naproxen sodium was more effective than acetaminophen over 12 h. Keywords: Acetaminophen; anti- ...

2. journals.lww.com journals.lww.com/md-journal/fulltext/2020/05080/efficacy_and_safety_of_over_the_counter_analgesics.8.aspx

Efficacy and safety of over-the-counter analgesics for primary As for efficacy outcomes, all the included analgesics except aspirin were more effective than placebo in treating dysmenorrhea [naproxen (OR 3.99, 95% CI 2.18– ...

3. aleve.com aleve.com/healthcare-professionals/efficacy-and-pain-guidelines/primary-dysmenorrhea

Primary Dysmenorrhea Pain Study and Guidelines Efficacy and Pain Guidelines ... (naproxen sodium) provided more pain relief over 12 hours than acetaminophen for menstrual cramps due to primary dysmenorrhea.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06861920

NSAID Use for Treating Dysmenorrhea and Preventing ... The goal of this clinical trial is to learn if NSAIDs (i.e. naproxen sodium) can treat menstrual pain and prevent the development of chronic pelvic pain in ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149291802800431

a pooled analysis of five studies Conclusion: When administered at OTC doses, naproxen was effective in the relief of pain and other symptoms of primary dysmenorrhea and had a good safety ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/naproxen-oral-route/description/drg-20069820

Naproxen (oral route) - Side effects & dosage Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, ...

7. aleve.com aleve.com/products/aleve-caplets

Aleve® Caplets | Product Information Temporarily relieves minor aches and pains due to: Minor pain of arthritis; Muscular aches; Backache; Menstrual cramps; Headache; Toothache; The common cold.

8. webmd.com webmd.com/drugs/2/drug-5173-1289/naproxen-oral/naproxen-oral/details

Naproxen (Aleve, Naprosyn, others) - Uses, Side Effects, ... Naproxen is commonly used to reduce fever and to treat pain and inflammation caused by several conditions, including arthritis, gout, ankylosing spondylitis, ...

9. drugs.com drugs.com/naproxen.html

Naproxen: Uses, Dosage, Side Effects, Warnings Naproxen is used to treat pain or inflammation caused by conditions such as arthritis, ankylosing spondylitis, tendinitis, bursitis, gout, or menstrual cramps.