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

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: Completed
• Conditions: Dysmenorrhea Primary; Vitamin E; Mefenamic Acid
• Intervention / Treatment: Drug: Mefenamic acid; Drug: Vitamin E capsule

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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)	After enrollment, two days before menstruation to three days in menstrual cycle

Collaborators and Investigators

• Sponsor: Nishtar Medical University
• Investigators: Study Chair: Shazia S Assistant Professor, FCPS, Nishtar Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Actual): January 14, 2026
• Study Completion (Actual): January 14, 2026

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 8, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Vitamin E; Menstrual cycle; Mefenamic acid
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrans; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Benzene Derivatives; Acids, Carbocyclic; Benzopyrans; Aminobenzoates; Benzoates; Fenamates; ortho-Aminobenzoates; Vitamin E; Tocopherols; alpha-Tocopherol; Mefenamic Acid
• Other Study ID 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