Vitamin E Plus Mefenamic Acid Versus Mefenamic Acid Alone for Treating Primary Dysmenorrhea in Women

March 8, 2026 updated by: Hina Javaid, Nishtar Medical University

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:

• 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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Multan, Punjab Province, Pakistan, 60000
        • Nishtar Medical University and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primary Dysmenorrhea for ≥3-months

Exclusion Criteria:

  • Patients already taking Vitamin E therapy
  • Having secondary dysmenorrhea like fibroid, endometriosis, adenomyosis and ovarian cyst on ultrasound

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Monotherapy
Participants will be given Mefenamic acid only
Drug: Mefenamic acid
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
Other Names:
  • Ponstan
Experimental: Combination Therapy
Participants will be given Mefenamic acid plus Vitamin E
Drug: Mefenamic acid
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
Other Names:
  • Ponstan
Drug: Vitamin E 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
Other Names:
  • Tocopheryl Acetate
  • Evion capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
After enrollment, two days before menstruation to three days in menstrual cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nishtar Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Shazia S Assistant Professor, FCPS, Nishtar Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • U1111-1336-6691

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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