DysmenorrheaPhase 4NCT03448536
A Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea
A Phase 4 study testing Naproxen Sodium, (Aleve, BAY117031) and Acetaminophen (Tylenol Extra Strength) in people with Dysmenorrhea, run by Bayer at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 35 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Naproxen Sodium, (Aleve, BAY117031) and Acetaminophen (Tylenol Extra Strength)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 8 sitesUnited States
- Study dates
- 5 Apr 2018to 5 Sep 2018
- 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 15 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ambulatory healthy female patients between 15 and 35 years of age;
- Patient has a history of Over-the-Counter (OTC) analgesic use for treatment of primary dysmenorrhea;
- Patient has a history of regular menstrual cycles that typically occurs between every 21 to 35 days;
- Patient has a self-reported history of primary dysmenorrhea (onset <5 years after menarche) with at least moderate menstrual cramp pain (based on the categorical pain intensity scale, 0-3) occurring during four of the past six menstrual cycles;
- Patient has a self-reported history of primary dysmenorrhea with other causes of dysmenorrhea having been excluded;
- Patient typically requires at least one dose of an OTC analgesic medication such as naproxen, aspirin, acetaminophen, or ibuprofen taken on at least 1 day of her menstrual cycle for the treatment of moderate or severe menstrual cramp, and normally experiences pain relief from these medications;
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- Patient is of child-bearing potential and is using one of the following methods of contraception and agrees to continue this same method for the duration of the study:
- Abstinence for at least the last 60 days AND willingness to use double barrier method should the patient become sexually active during the study;
- Double barrier method (condom with contraceptive foam, diaphragm with contraceptive gel);
- Permanent sterilization of patient or her spouse/partner;
- Oral contraceptive (must have been using the same oral contraceptive for at least three months prior to study entry and agrees to remain on the same type and method throughout the course of the study).
- Patient is willing to participate in the study and return to the study site within approximately 1 week after her menstrual cycle to return the study medication, urine pregnancy test, and for review of the completed patient e-diary;
- Patient is willing to abstain from alcohol consumption throughout the 12-hour Treatment Period;
- Patient is willing to abstain from caffeine consumption throughout the 12-hour Treatment Period;
- Patient is willing to ingest the overencapsulated tablets throughout the study;
- Patient is willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other study procedures according to the clinical protocol.
Who cannot join
- Patient has a known history of allergic, idiosyncratic or serious adverse reaction, to acetaminophen, naproxen, aspirin, ibuprofen, or any other nonsteroidal anti-inflammatory drug (NSAID);
- Patient has a known allergy to any of the excipients in any of the study medication products;
- Patient has experienced asthma, urticaria, or allergic-type reactions after taking aspirin, acetaminophen or other NSAIDs;
- Patient has significant co-existing illness, including gastrointestinal, hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure or other condition that, in the Investigator's judgment, contraindicates administration of the study medication;
- Patient has a current or past history of severe gastritis, gastrointestinal bleeding or ulceration;
- Patient has a current or past history of one or more of the following conditions: secondary dysmenorrhea, pelvic inflammatory disease, urinary tract infection (currently acute or recurrent [defined as more than three per year] prior history of an urinary tract infection is eligible for enrollment), adnexal masses, uterine fibroids, endometriosis, adenomyosis that in the opinion of the Investigator would impact patient safety and/or the study data;
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- Patient has an ongoing sexually transmitted disease (except for a history of genital herpes or Human Papillomavirus) or has abnormal vaginal discharge;
- Patient requires prescription analgesics, narcotic, non-NSAID (i.e., defined as oral use of 5 or more times per week for greater than 3 weeks) or has routinely taken OTC medications in excess of label recommended instructions for control of dysmenorrhea symptoms;
- Patient is taking mood-altering agents (e.g., antidepressants, sedatives, phenothiazines, or anti-anxiety agents). Patients who are on a stable dose for at least 3 months, and not taking this medication for dysmenorrhea or premenstrual syndrome are eligible for enrollment;
- Patient does not agree to abstain from taking any analgesic and/or anti-inflammatory medication (with the exception of low dose aspirin [defined as no greater than 100 mg daily] taken for cardioprotective purposes) approximately 72 hours prior to the anticipated treatment period and throughout the dosing/assessment period. All pain and anti-inflammatory medications including supplements, topical heat or cold, and other products of topical application will be discontinued approximately 72 hours prior to the anticipated dosing for each treatment period and throughout the dosing/assessment period;
- Patient does not agree to abstain from using transcutaneous electrical nerve stimulation devices that are used to treat dysmenorrhea throughout each treatment period;
- Patient is taking piroxicam (Feldene®) or oral corticosteroids. Patients taking inhaled or topical corticosteroids are eligible for enrollment;
- Patient is pregnant, lactating , or less than 6 months postpartum;
- Patient is currently using an intra-uterine devices (IUD), or using hormonal implants (e.g., Norplant) or injections (e.g., Depo-Provera) for contraception or used within the past 6 months;
- Patient is currently using an oral contraceptive for less than 3 months, has been on a unstable dose within the last 3 months or has switched from one oral contraceptive to another within the last 3 months or intends to do so in the course of the study;
- Patient has a history of chronic abuse of alcohol (regularly consumes 3 or more alcoholic drinks per day), analgesics, narcotic analgesics, ergot alkaloids, tranquilizers, or opioids or other substances known to produce dependence; in the judgement of the investigator within the past 3 years;
- Positive drug at screening and visit 2 for illegal drug substances, or non-prescribed controlled substances;
- Positive pregnancy test or breast feeding at screening and prior to dosing in each Treatment Period;
- Patients with a medical disorder, condition or history such that could impair the patient's ability to participate or complete this study in the opinion of the investigator.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Radiant Research, Inc.
Akron, Ohio, 44311
Radiant Research, Inc.
Chandler, Arizona, 85224
Radiant Research, Inc.
Chicago, Illinois, 60602
Radiant Research, Inc.
Cincinnati, Ohio, 45236
Radiant Research, Inc.
Dallas, Texas, 75234
Radiant Research, Inc.
Pinellas Park, Florida, 33781
Synexus US, LP- Plano
Plano, Texas, 75234
Radiant Research, Inc.
Scottsdale, Arizona, 85251
About this study
Official title: A Double-Blind, Randomized, Crossover Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea
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.
- Conditions
- Dysmenorrhea
- Being tested
- Naproxen Sodium, (Aleve, BAY117031), Acetaminophen (Tylenol Extra Strength)
- Keywords
- Primary dysmenorrhea of at least moderate severity
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen Sodium, (Aleve, BAY117031)Drug
220 mg *2 tablets, orally, single dose
Acetaminophen (Tylenol Extra Strength)Drug
500 mg *2 caplets, orally, single dose
| Study group | Role | What they receive |
|---|---|---|
| Naproxen Sodium : Acetaminophen | Experimental | 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 Receives: Drug: Naproxen Sodium, (Aleve, BAY117031); Drug: Acetaminophen (Tylenol Extra Strength) |
| Acetaminophen : Naproxen Sodium | Experimental | 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 Receives: Drug: Naproxen Sodium, (Aleve, BAY117031); Drug: Acetaminophen (Tylenol Extra Strength) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 hours post-dose
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.'
Measured: 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).
Measured: Up to 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start5 Apr 2018
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448536
- Sponsor's protocol ID
- 19737
- Other IDs
- 2017-005031-17, 2017
- Status last verified
- Oct 2019
- First submitted
- 9 Feb 2018
- Last updated
- 28 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Daniels SE, Paredes-Diaz A, An R, Centofanti R, Tajaddini A. Significant, long-lasting pain relief in primary dysmenorrhea with low-dose naproxen sodium compared with acetaminophen: a double-blind, randomized, single-dose, crossover study. Curr Med Res Opin. 2019 Dec;35(12):2139-2147. doi: 10.1080/03007995.2019.1654987. Epub 2019 Aug 28.
PubMed 31397597
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Crossover Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT03448536
- Acronym / sponsor ID
- 19737
- Conditions
- Dysmenorrhea
- Keywords
- Primary dysmenorrhea of at least moderate severity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Posted 28 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naproxen Sodium : Acetaminophen | Experimental | Drug: Naproxen Sodium, (Aleve, BAY117031), Drug: Acetaminophen (Tylenol Extra Strength)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 |
| Acetaminophen : Naproxen Sodium | Experimental | 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 |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Ambulatory healthy female patients between 15 and 35 years of age;
- Patient has a history of Over-the-Counter (OTC) analgesic use for treatment of primary dysmenorrhea;
- Patient has a history of regular menstrual cycles that typically occurs between every 21 to 35 days;
- Patient has a self-reported history of primary dysmenorrhea (onset <5 years after menarche) with at least moderate menstrual cramp pain (based on the categorical pain intensity scale, 0-3) occurring during four of the past six menstrual cycles;
- Patient has a self-reported history of primary dysmenorrhea with other causes of dysmenorrhea having been excluded;
Key exclusion criteria (19 listed)
- Patient has a known history of allergic, idiosyncratic or serious adverse reaction, to acetaminophen, naproxen, aspirin, ibuprofen, or any other nonsteroidal anti-inflammatory drug (NSAID);
- Patient has a known allergy to any of the excipients in any of the study medication products;
- Patient has experienced asthma, urticaria, or allergic-type reactions after taking aspirin, acetaminophen or other NSAIDs;
- Patient has significant co-existing illness, including gastrointestinal, hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure or other condition that, in the Investigator's judgment, contraindicates administration of the study medication;
- Patient has a current or past history of severe gastritis, gastrointestinal bleeding or ulceration;
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 |
|---|---|---|
| Naproxen Sodium, (Aleve, BAY117031)220 mg *2 tablets, orally, single dose | Drug | Acetaminophen : Naproxen Sodium, Naproxen Sodium : Acetaminophen |
| Acetaminophen (Tylenol Extra Strength)500 mg *2 caplets, orally, single dose | Drug | Acetaminophen : Naproxen Sodium, Naproxen Sodium : Acetaminophen |
Primary outcome
Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours
Time frame: Up to 12 hours post-dose
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.
9 secondary outcomes
Summed Pain Intensity Difference (SPID) Over 0-12 Hours
Time frame: Up to 12 hours post-dose
SPID Over 0-6 Hours
Time frame: Up to 6 hours post-dose
SPID Over 6-12 Hours
Time frame: From 6 hours to 12 hours post-dose
TOTPAR Over 0-6 Hours
Time frame: Up to 6 hours post-dose
TOTPAR 6-12 Hours
Time frame: From 6 hours to 12 hours post-dose
Time to First Intake of Rescue Medication
Time frame: Up to 12 hours post-dose
Pain Intensity Difference (PID) Scores at Each Evaluation
Time frame: Up to 12 hours post-dose
Number of Participants by Global Evaluation Scores
Time frame: Up to 12 hours post-dose
Pain Relief Scores at Each Evaluation
Time frame: Up to 12 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31397597Daniels SE, Paredes-Diaz A, An R, Centofanti R, Tajaddini A. Significant, long-lasting pain relief in primary dysmenorrhea with low-dose naproxen sodium compared with acetaminophen: a double-blind, randomized, single-dose, crossover study. Curr Med Res Opin. 2019 Dec;35(12):2139-2147. doi: 10.1080/03007995.2019.1654987. Epub 2019 Aug 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen Sodium, (Aleve, BAY117031) and Acetaminophen (Tylenol Extra Strength) in people with Dysmenorrhea, run by Bayer at 8 sites 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 16 inclusion and 19 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 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 28 Oct 2019). 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?
Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours (time frame: Up to 12 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448536, which also lists 1 linked publication.
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 28 Oct 2019.