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Diagnostic and Therapeutic Potential of Substance P/ NK1R Receptor in Primary Dysmenorrhea

NCT06317064 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-21

No results posted yet for this study

Summary

Dysmenorrhea is characterized as excruciating menstrual cramps of uterine origin and is one of the most prevalent gynecological illnesses. Substance P (SP) and NK1R mediate the symptoms of various pain disorders with chronic and/or neuropathic pain. Objective: To evaluate diagnostic and therapeutic potential of Substance P/ NK1R receptor in primary dysmenorrhea. Study Design: This was a randomized controlled trial which took place at Lahore Medical Research Center from March 2024 to October 2024. Non-probability convenient sampling techniques was used for sampling. A total of 40 female participants was included in the study who met specific criteria for inclusion. The study comprised of three phases, Phase 1 (Before medication), Phase 2 (NSAIDs) and Phase 3(Dexamethasone + Aprepitant). 10 females with no dysmenorrhea participated as controls. The study duration spanned three menstrual cycles. 20 dysmenhorric and 6 controls were analyzed for NK1R levels. Several assessment tools were also used in the study,

Conditions

  • Primary Dysmenorrhea

Interventions

DRUG

Ibuprofen and Aprepitant

All 30 participants in this group used NSAIDs (Non-steroidal Anti-Inflammatory Drugs), during their dysmenorrhea period. Same patients from phase 2 (n=30) in next cycle received NK1R antagonist "Dexamethasone (6mg) + Aprepitant (80mg)" for 2 days.

Sponsors & Collaborators

  • Lahore Medical Research Center, LLP

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2024-10-31
Completion
2024-12-15

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06317064 on ClinicalTrials.gov