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

NCT07466342 | Completed Phase 4

• 1 other identifier: U1111-1336-6691
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dysmenorrhea Primary; Vitamin E; Mefenamic Acid

Keywords

Menstrual cycle; Pain; Vitamin E; Mefenamic acid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Monotherapy

ACTIVE COMPARATOR

Participants will be given Mefenamic acid only

Drug: Mefenamic acid

Combination Therapy

EXPERIMENTAL

Participants will be given Mefenamic acid plus Vitamin E

Drug: Mefenamic acid; Drug: Vitamin E capsule

Interventions

Mefenamic acid DRUG

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

Also known as: Ponstan

Combination Therapy; Monotherapy

Vitamin E capsule DRUG

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

Also known as: Tocopheryl Acetate, Evion capsule

Combination Therapy

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Primary Dysmenorrhea for ≥3-months

You may not qualify if:

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

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Medical University and Hospital

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Pain

Interventions

Mefenamic Acid; Vitamin E; alpha-Tocopherol; Tocopherols

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fenamates; ortho-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shazia S Assistant Professor, FCPS

  Nishtar Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 12, 2026
• Study Start: July 15, 2025
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)