Trial reportObstetrics and gynecology2009
Combination treatment for menstrual migraine and dysmenorrhea using sumatriptan-naproxen: two randomized controlled trials.
Trial report in Obstetrics and gynecology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 29 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Single Migraine Attack, Placebo-controlled, Parallel-group Multicenter Study to Evaluate the Efficacy and Tolerability of Trexima (Sumatriptan Succinate.Naproxen Sodium) Tablets vs Placebo When Administered During the Mild Pain Phase of Menstrual Migraine in Women With Dysmenorrhea
A Randomized, Double-blind, Single Migraine Attack, Placebo -Controlled, Patallel-group Multicenter Study to Evaluate the Efficacy and Tolerability or Trexima (Sumatriptan Succinate/Naproxen Sodium) Tablets vs Placebo When Administered During the Mild Pain Phase of Menstrual Migraine in Women With Dysmenorrhea
Who cites it
29 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Acute and preventive treatment of menstrual migraine: a meta-analysis.The journal of headache and pain · 2024Pooled it
- Comparative efficacy of different treatments for menstrual migraine: a systematic review and network meta-analysis.The journal of headache and pain · 2023Pooled it
- Sumatriptan plus naproxen for the treatment of acute migraine attacks in adults.The Cochrane database of systematic reviews · 2016Pooled it
- Nonsteroidal anti-inflammatory drugs for dysmenorrhoea.The Cochrane database of systematic reviews · 2015Pooled it
- Frovatriptan 2.5 mg plus dexketoprofen (25 mg or 37.5 mg) in menstrually related migraine. Subanalysis from a double-blind, randomized trial.Cephalalgia : an international journal of headache · 2015Trial
- Frovatriptan plus dexketoprofen in the treatment of menstrually related migraine: an open study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2013Trial
- Frovatriptan versus almotriptan for acute treatment of menstrual migraine: analysis of a double-blind, randomized, cross-over, multicenter, Italian, comparative study.The journal of headache and pain · 2012Trial
- Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind, randomized, cross-over, multicenter, Italian, comparative study versus rizatriptan.The journal of headache and pain · 2011Trial
- Efficacy of frovatriptan in the acute treatment of menstrually related migraine: analysis of a double-blind, randomized, multicenter, Italian, comparative study versus zolmitriptan.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2011Trial
- Sex-specific considerations in migraine therapy.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026Review
- Moderate to Severe Acute Migraine Attacks: An Opinion Paper on the Use of Triptans and Triptan-NSAIDs Combinations in Individualized Treatment Plans.Neurology and therapy · 2026Review
- Framing and Management of Migraines in Women: An Expert Opinion on Challenges, Current Approaches, and Future Multidisciplinary Perspectives.Healthcare (Basel, Switzerland) · 2025Article
- Sumatriptan-naproxen sodium in migraine: A review.European journal of neurology · 2024Review
- Review
- Acute and Preventive Management of Migraine during Menstruation and Menopause.Journal of clinical medicine · 2021Review
- Migraine Treatment: Current Acute Medications and Their Potential Mechanisms of Action.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2018Review
- Network meta-analysis of migraine disorder treatment by NSAIDs and triptans.The journal of headache and pain · 2016Article
- Review
- Relief of menstrual symptoms and migraine with a single-tablet formulation of sumatriptan and naproxen sodium.Journal of women's health (2002) · 2014Article
- Sumatriptan/naproxen sodium combination versus its components administered concomitantly for the acute treatment of migraine: a pragmatic, crossover, open-label outcomes study.Therapeutic advances in neurological disorders · 2013Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the efficacy and tolerability of sumatriptan-naproxen during the mild pain phase of a single menstrual migraine attack associated with dysmenorrhea.
methodsTwo replicate randomized, multicenter, double-blind, placebo-controlled, trials of adults with menstrual migraine and dysmenorrhea were conducted. Participants treated their menstrual migraine attack during the mild pain phase (within 1 hour of onset) with sumatriptan 85 mg and naproxen sodium 500 mg in a single fixed-dose formulation (sumatriptan-naproxen) or placebo. The primary endpoint was 2-hour pain-free response.
resultsSumatriptan-naproxen was statistically superior to placebo in both studies (n=311, Study 1; n=310, Study 2) for 2-hour and, 2- to 24-hour sustained pain-free response, use of headache and menstrual rescue medications, and several nonpain menstrual symptom categories. Two-hour pain-free rates were Study 1, 42% compared with 23%, and Study 2, 52% compared with 22%, P<.001. Two- to 24-hour sustained pain-free rates were Study 1, 29% compared with 18%, P=.022; Study 2, 38% compared with 10%, P<.001. Headache and menstrual medication rates were Study 1, 37% compared with 53%, P=.005; Study 2, 31% compared with 69%, P<.001. Women treated with sumatriptan-naproxen continued to be pain free through 48 hours compared with placebo: Study 1, 26% compared with 17%, P=.040; Study 2, 28% compared with 8%, P<.001. No serious adverse events were reported in either study; nausea and dizziness were the most frequently reported adverse events.
conclusionSumatriptan-naproxen provided an effective pain-free response at 2 hours, which was maintained up to 48 hours in menstrual migraineurs with dysmenorrhea. Sumatriptan-naproxen was well-tolerated and resulted in decreased rescue medication use and relief of nonpainful menstrual symptoms. CLINICAL
trial registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT00329459 and NCT00329355 LEVEL OF EVIDENCE: I.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.