A Phase 4 interventional study of Naproxen Sodium, (Aleve, BAY117031) and Acetaminophen (Tylenol Extra Strength) in Dysmenorrhea, sponsored by Bayer. Completed at 8 sites in United States. Open to female participants aged 15 Years to 35 Years. Per ClinicalTrials.gov, last updated 2019-10-28.
Sponsored by Bayer · Phase 4, Interventional, and Treatment
Among 11 studies in Dysmenorrhea by Bayer — none open to participants now, none under way, none of them phase 3. Dysmenorrhea · Bayer.
Among the 11 studies in Dysmenorrhea by Bayer, this one is the only one that started in 2018, is the only one in phase 4, and was the 10th registered.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's enrollment of 201 is above the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →None of the 11 studies in Dysmenorrhea by Bayer is open now.
Of the 57 Dysmenorrhea studies recruiting now, 7 (12%) set no upper age limit and 49 (86%) stop at 75 or younger; 11 take children under 18; 20 take healthy volunteers.
This study: 15 Years to 35 Years · female · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2018.
Median enrollment 223 across the 7 interventional studies, 658 across the 4 observational. Of the 10 that completed or were terminated, 4 (40%) have results posted.
Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Dysmenorrhea by Bayer, from their registry updates:
Nothing recorded among them since 2026-09-25.
The purpose of this study is to compare the maximum single dose of Aleve® (two tablets, equivalent to 440 mg of naproxen sodium) to the maximum single dose of Tylenol Extra Strength (two caplets, equivalent to 1000 mg of acetaminophen) in the treatment of menstrual pain associated with primary dysmenorrhea.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient is of and is using one of the following methods of and agrees to continue this same method for the duration of the study:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects received one single oral dose of 440 mg naproxen sodium in treatment period 1, followed by one single oral dose of 1000 mg acetaminophen in treatment period 2
Drug: Naproxen Sodium, (Aleve, BAY117031) · Drug: Acetaminophen (Tylenol Extra Strength)
Subjects received one single oral dose of 1000 mg acetaminophen in treatment period 1, followed by one single oral dose of 440 mg naproxen sodium in treatment period 2
Drug: Naproxen Sodium, (Aleve, BAY117031) · Drug: Acetaminophen (Tylenol Extra Strength)
220 mg \*2 tablets, orally, single dose
500 mg \*2 caplets, orally, single dose
Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 46. Higher scores was indicative of more pain relief.
Time frame: Up to 12 hours post-dose
Summed Pain Intensity Difference (SPID) Over 0-12 Hours
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -115, and the maximum value could be 115.
Time frame: Up to 12 hours post-dose
SPID Over 0-6 Hours
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -55, and the maximum value could be 55.
Time frame: Up to 6 hours post-dose
SPID Over 6-12 Hours
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -60, and the maximum value could be 60.
Time frame: From 6 hours to 12 hours post-dose
TOTPAR Over 0-6 Hours
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 22. Higher scores was indicative of more pain relief.
Time frame: Up to 6 hours post-dose
TOTPAR 6-12 Hours
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 24. Higher scores was indicative of more pain relief.
Time frame: From 6 hours to 12 hours post-dose
Time to First Intake of Rescue Medication
Time to first intake of rescue medication was defined as the number of hours elapsed between time of dose and time of rescue medication in each treatment period. Participants would be censored at time of last pain assessment.
Time frame: Up to 12 hours post-dose
Pain Intensity Difference (PID) Scores at Each Evaluation
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement.
Time frame: Up to 12 hours post-dose
Number of Participants by Global Evaluation Scores
Global evaluation was performed either at 12 hours post-dose or immediately prior to the first intake of rescue medication. Global Evaluation Score was based on the question 'Overall, I would rate the effectiveness of the study medication in relieving my menstrual pain as: 0=Poor, 1=Fair, 2=Good, 3=Very Good, 4=Excellent.'
Time frame: Up to 12 hours post-dose
Pain Relief Scores at Each Evaluation
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).
Time frame: Up to 12 hours post-dose
Study was conducted at multiple centers in the US between 05 April 2018 (first patient first visit) and 05 September 2018 (last patient last visit).
| Milestone | Naproxen Sodium : Acetaminophen | Acetaminophen : Naproxen Sodium |
|---|---|---|
| Started | 100 | 101 |
| Completed first intervention | 83 | 78 |
| Completed first intervention | 95 | 97 |
| Completed second intervention | 82 | 87 |
| Completed | 88 | 97 |
| Not completed | 12 | 4 |
| Withdrew: Protocol violation | 2 | 0 |
| Withdrew: Pregnancy | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Lost to follow-up | 3 | 2 |
| Withdrew: Inadequate pain reporter | 1 | 0 |
| Withdrew: Other | 3 | 0 |
| Withdrew: Physician decision | 1 | 0 |
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 46. Higher scores was indicative of more pain relief.
| Scores on a scale * hours | Naproxen Sodium | Acetaminophen |
|---|---|---|
| Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours | 29.18 ± 1.003 | 24.87 ± 1.029 |
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -115, and the maximum value could be 115.
| Scores on a scale * hours | Naproxen Sodium | Acetaminophen |
|---|---|---|
| Summed Pain Intensity Difference (SPID) Over 0-12 Hours | 53.62 ± 1.931 | 43.82 ± 1.977 |
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -55, and the maximum value could be 55.
| Scores on a scale * hours | Naproxen Sodium | Acetaminophen |
|---|---|---|
| SPID Over 0-6 Hours | 23.47 ± 0.902 | 21.94 ± 0.925 |
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -60, and the maximum value could be 60.
| Scores on a scale * hours | Naproxen Sodium | Acetaminophen |
|---|---|---|
| SPID Over 6-12 Hours | 30.15 ± 1.252 | 21.88 ± 1.280 |
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 22. Higher scores was indicative of more pain relief.
| Scores on a scale * hours | Naproxen Sodium | Acetaminophen |
|---|---|---|
| TOTPAR Over 0-6 Hours | 13.46 ± 0.451 | 12.90 ± 0.463 |
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 24. Higher scores was indicative of more pain relief.
| Scores on a scale * hours | Naproxen Sodium | Acetaminophen |
|---|---|---|
| TOTPAR 6-12 Hours | 15.72 ± 0.661 | 11.97 ± 0.677 |
Time to first intake of rescue medication was defined as the number of hours elapsed between time of dose and time of rescue medication in each treatment period. Participants would be censored at time of last pain assessment.
| Hours | Naproxen Sodium | Acetaminophen |
|---|---|---|
| Time to First Intake of Rescue Medication | NA (NA to NA) | NA (NA to NA) |
Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement.
| Scores on a scale | Naproxen Sodium | Acetaminophen |
|---|---|---|
| 30 minutes | 0.8 ± 1.47 | 0.9 ± 1.61 |
| 1 hour | 1.9 ± 1.93 | 2.1 ± 2.01 |
| 3 hours | 4.1 ± 2.40 | 4.0 ± 2.68 |
| 6 hours | 5.1 ± 2.59 | 4.3 ± 2.90 |
| 9 hours | 4.9 ± 2.93 | 3.6 ± 3.13 |
| 12 hours | 5.0 ± 2.97 | 3.5 ± 3.37 |
Global evaluation was performed either at 12 hours post-dose or immediately prior to the first intake of rescue medication. Global Evaluation Score was based on the question 'Overall, I would rate the effectiveness of the study medication in relieving my menstrual pain as: 0=Poor, 1=Fair, 2=Good, 3=Very Good, 4=Excellent.'
| Participants | Naproxen Sodium | Acetaminophen |
|---|---|---|
| Poor | 10 | 13 |
| Fair | 26 | 42 |
| Good | 25 | 38 |
| Very good | 60 | 38 |
| Excellent | 35 | 25 |
Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).
| Scores on a scale | Naproxen Sodium | Acetaminophen |
|---|---|---|
| 30 minutes | 0.9 ± 0.98 | 0.9 ± 1.01 |
| 1 hour | 1.4 ± 1.06 | 1.6 ± 1.12 |
| 3 hours | 2.3 ± 1.17 | 2.3 ± 1.32 |
| 6 hours | 2.7 ± 1.45 | 2.4 ± 1.50 |
| 9 hours | 2.6 ± 1.52 | 2.0 ± 1.57 |
| 12 hours | 2.7 ± 1.60 | 1.9 ± 1.69 |
Collected over The observation phase for adverse events (AEs) started with signing the informed consent form and ended in general with the last visit of follow-up (up to 133 days). After the end of follow-up there was no requirement to actively collect AEs.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Naproxen Sodium | 0/192 (0%) | 0/192 (0%) | 12/192 (6.3%) |
| Acetaminophen | 0/185 (0%) | 0/185 (0%) | 9/185 (4.9%) |
| Event | Naproxen Sodium | Acetaminophen |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 3/192 | 0/185 |
| Pharyngitis streptococcalInfections and infestations | 1/192 | 2/185 |
| NauseaGastrointestinal disorders | 2/192 | 1/185 |
| Eye pruritusEye disorders | 1/192 | 1/185 |
| Urinary tract infectionInfections and infestations | 0/192 | 1/185 |
| Nail avulsionInjury, poisoning and procedural complications | 0/192 | 1/185 |
| Vitamin D deficiencyMetabolism and nutrition disorders | 0/192 | 1/185 |
| Attention deficit/hyperactivity disorderPsychiatric disorders | 0/192 | 1/185 |
| AmenorrhoeaReproductive system and breast disorders | 0/192 | 1/185 |
| GastritisGastrointestinal disorders | 1/192 | 0/185 |
Safety population (included all randomized participants who took at least one dose of investigational medicinal product \[IMP\])
| Age, Continuous(years) | Naproxen Sodium : Acetaminophen | Acetaminophen : Naproxen Sodium | Total |
|---|---|---|---|
| Mean | 24.7 ± 5.60 | 25.0 ± 5.77 | 24.8 ± 5.67 |
| Sex: Female, Male(Participants) | Naproxen Sodium : Acetaminophen | Acetaminophen : Naproxen Sodium | Total |
|---|---|---|---|
| Female | 96 | 100 | 196 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Naproxen Sodium : Acetaminophen | Acetaminophen : Naproxen Sodium | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 14 | 27 |
| Not Hispanic or Latino | 83 | 85 | 168 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Naproxen Sodium : Acetaminophen | Acetaminophen : Naproxen Sodium | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 6 | 2 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 23 | 27 | 50 |
| White | 66 | 68 | 134 |
| More than one race | 0 | 2 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| At least moderate pain intensity during 4 of last 6 menstrual cycles(Participants) | Naproxen Sodium : Acetaminophen | Acetaminophen : Naproxen Sodium | Total |
|---|---|---|---|
| Yes | 96 | 100 | 196 |
| No | 0 | 0 | 0 |
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Studies of the drugs tested here: Naproxen · Acetaminophen