Dysmenorrhea PrimaryPhase 4NCT07466342
Vitamin E Plus Mefenamic Acid Versus Mefenamic Acid Alone for Treating Primary Dysmenorrhea in Women
A Phase 4 study testing Mefenamic acid and Vitamin E capsule in people with Dysmenorrhea Primary and Vitamin E, run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to determine whether adding vitamin E to mefenamic acid reduces menstrual pain more effectively than mefenamic acid alone in women with primary dysmenorrhea. Primary dysmenorrhea refers to painful menstrual cramps that occur without an underlying pelvic disease. Read more about this study
- Who is it for?
- Ages 15 to 35 years, women only
- Conditions the study is for
- Dysmenorrhea Primary, Vitamin E, Mefenamic Acid
- What is being tested?
- Mefenamic acid and Vitamin E capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2025to 14 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Primary Dysmenorrhea for ≥3-months
Who cannot join
- Patients already taking Vitamin E therapy
- Having secondary dysmenorrhea like fibroid, endometriosis, adenomyosis and ovarian cyst on ultrasound
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Nishtar Medical University and Hospital
Multan, Punjab Province, 60000
About this study
Official title: Comparison of Vitamin E in Combination With Mefenamic Acid Versus Mefenamic Acid Alone for Management of Primary Dysmenorrhea
The goal of this clinical trial is to determine whether adding vitamin E to mefenamic acid reduces menstrual pain more effectively than mefenamic acid alone in women with primary dysmenorrhea. Primary dysmenorrhea refers to painful menstrual cramps that occur without an underlying pelvic disease.
The main question this study aims to answer is:
Read more
- Does the combination of vitamin E and mefenamic acid reduce menstrual pain more than mefenamic acid alone?
Researchers will compare two groups of women aged 15-35 years who experience primary dysmenorrhea. One group will receive mefenamic acid together with vitamin E, while the other group will receive mefenamic acid alone.
A total of 60 participants will be enrolled and randomly assigned to one of the two treatment groups. Participants in the combination group will take mefenamic acid 400 mg with vitamin E 400 IU at the start of their menstrual cycle. Participants in the comparison group will take mefenamic acid 400 mg alone at the start of their menstrual cycle.
Pain will be measured using a Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents severe pain. Pain scores will be recorded at the time of enrollment and again during the second menstrual cycle after starting treatment.
The study will evaluate whether the average pain score during the second menstrual cycle is lower in women who receive vitamin E together with mefenamic acid compared with those who receive mefenamic acid alone. The findings may help determine whether adding vitamin E can improve the management of primary dysmenorrhea.
- Conditions
- Dysmenorrhea Primary, Vitamin E, Mefenamic Acid
- Being tested
- Mefenamic acid, Vitamin E capsule
- Keywords
- Menstrual cycle, Pain, Vitamin E, Mefenamic acid
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mefenamic acidDrug
Also called Ponstan
All participants will be given 250 mg of Mefenamic acid (Tablet Ponstan), twice daily, for 5 days: two days before the start of menstruation to three days in menstrual cycle
Vitamin E capsuleDrug
Also called Tocopheryl Acetate, Evion capsule
All participants will be given 200 mg of Vitamin E (Evion capsule), twice daily, for 5 days: two days before the start of menstruation to three days in menstrual cycle
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Active comparator | Participants will be given Mefenamic acid only Receives: Drug: Mefenamic acid |
| Combination Therapy | Experimental | Participants will be given Mefenamic acid plus Vitamin E Receives: Drug: Mefenamic acid; Drug: Vitamin E capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score
Pain will be assessed using Visual analogue Scale, for five days, two days before menstruation to three days in menstrual cycle.
Mean Pain Score = (VAS Day 1 + Day 2 + Day 3 + Day 4 + Day 5) ÷ 5 Mean Pain Score in the Baseline Cycle (without treatment) and Cycle 2 (with study medication) will be recorded.
Change in Pain=Mean VAS (Cycle 2)-Mean VAS (Baseline Cycle)
Measured: After enrollment, two days before menstruation to three days in menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start15 Jul 2025
- Primary completion14 Jan 2026
- Study completion14 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hina Javaid, Nishtar Medical University
- Investigators
- Shazia S Assistant Professor, FCPS, Study chair, Nishtar Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466342
- Sponsor's protocol ID
- U1111-1336-6691
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vitamin E in Combination With Mefenamic Acid Versus Mefenamic Acid Alone for Management of Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07466342
- Acronym / sponsor ID
- U1111-1336-6691
- Conditions
- Dysmenorrhea Primary, Vitamin E, Mefenamic Acid
- Keywords
- Menstrual cycle, Pain, Vitamin E, Mefenamic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 14 Jan 2026 (actual)
- Study completion
- 14 Jan 2026 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine whether adding vitamin E to mefenamic acid reduces menstrual pain more effectively than mefenamic acid alone in women with primary dysmenorrhea. Primary dysmenorrhea refers to painful menstrual cramps that occur without an underlying pelvic disease.
The main question this study aims to answer is:
- Does the combination of vitamin E and mefenamic acid reduce menstrual pain more than mefenamic acid alone?
Researchers will compare two groups of women aged 15-35 years who experience primary dysmenorrhea. One group will receive mefenamic acid together with vitamin E, while the other group will receive mefenamic acid alone.
A total of 60 participants will be enrolled and randomly assigned to one of the two treatment groups. Participants in the combination group will take mefenamic acid 400 mg with vitamin E 400 IU at the start of their menstrual cycle. Participants in the comparison group will take mefenamic acid 400 mg alone at the start of their menstrual cycle.
Pain will be measured using a Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents severe pain. Pain scores will be recorded at the time of enrollment and again during the second menstrual cycle after starting treatment.
The study will evaluate whether the average pain score during the second menstrual cycle is lower in women who receive vitamin E together with mefenamic acid compared with those who receive mefenamic acid alone. The findings may help determine whether adding vitamin E can improve the management of primary dysmenorrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | Active comparator | Drug: Mefenamic acidParticipants will be given Mefenamic acid only |
| Combination Therapy | Experimental | Drug: Mefenamic acid, Drug: Vitamin E capsuleParticipants will be given Mefenamic acid plus Vitamin E |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Primary Dysmenorrhea for ≥3-months
Key exclusion criteria (2 listed)
- Patients already taking Vitamin E therapy
- Having secondary dysmenorrhea like fibroid, endometriosis, adenomyosis and ovarian cyst on ultrasound
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 |
|---|---|---|
| Mefenamic acidAlso: PonstanAll participants will be given 250 mg of Mefenamic acid (Tablet Ponstan), twice daily, for 5 days: two days before the start of menstruation to three days in menstrual cycle | Drug | Combination Therapy, Monotherapy |
| Vitamin E capsuleAlso: Tocopheryl Acetate, Evion capsuleAll participants will be given 200 mg of Vitamin E (Evion capsule), twice daily, for 5 days: two days before the start of menstruation to three days in menstrual cycle | Drug | Combination Therapy |
Primary outcome
Change in Pain Score
Time frame: After enrollment, two days before menstruation to three days in menstrual cycle
Pain will be assessed using Visual analogue Scale, for five days, two days before menstruation to three days in menstrual cycle. Mean Pain Score = (VAS Day 1 + Day 2 + Day 3 + Day 4 + Day 5) ÷ 5 Mean Pain Score in the Baseline Cycle (without treatment) and Cycle 2 (with study medication) will be recorded. Change in Pain=Mean VAS (Cycle 2)-Mean VAS (Baseline Cycle)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Shazia S Assistant Professor, FCPS study chair
Nishtar Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mefenamic acid and Vitamin E capsule in people with Dysmenorrhea Primary and Vitamin E, run by Nishtar Medical University at 1 site in Pakistan.
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 1 inclusion and 2 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 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Pain Score (time frame: After enrollment, two days before menstruation to three days in menstrual cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.