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

NCT06317064 | Completed Phase 3 DMC

• 1 other identifier: LMRC-Aprepitant-Pain-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Substance P; Neurokinin 1 Receptor; Primary Dysmenorrhea; Aprepitant; Rosemary; Ibuprofen

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Scale Score (Pain scale)

  Female participants' levels of pain were measured using the Visual Analog Scale (VAS). With a scale from 0 to 10, where 10 is the most excruciating pain possible, the VAS is a well-known measure for assessing pain perception. Participants were divided into three groups to reflect varied levels of pain severity based on their VAS ratings obtained throughout the first three consecutive days of both menstrual cycles: Mild Pain, Moderate Pain, and Severe Pain

  At the end of one cycle (each cycle is of 28-3- days)

• Mini Nutritional Assessment (MNA) Score

  The female participants' eating patterns were assessed using the Nestle Nutrition Institute Mini Nutritional Assessment in order to look into any possible associations between their diet and menstrual discomfort. Participants who scored between 24 and 30 had good nutritional status, those who scored from 17 to 23.5 were at risk of malnutrition, and those who scored under 17 were poorly nourished.

  At the end of one cycle (each cycle is of 28-3- days)

• DASS-21 (Depression Anxiety Stress Scale)

  The DASS-21 was used to evaluate the psychological health of our subjects and comprehend how it related to dysmenorrhea. Based on their stated levels of stress, anxiety, and depression, participants were divided into five groups using this scale: normal, mild, moderate, severe, and extremely severe. A score of 0 to 9 indicates normal, 10 to 13 indicates mild depression, 14 to 20 indicates moderate depression, 21 to 27 indicates severe depression, and 28 or above indicates extremely severe depression. Scores between 0 and 7 indicate normal anxiety, 8 to 9 indicate mild anxiety, 10 to 14 indicate moderate anxiety, 15 to 19 indicate severe anxiety, and 20 or more indicate extremely severe anxiety. For stress, 0-14 represents normal, 15-18 represents mild, 19-25 represents moderate, 26-33 represents severe, and 34+ represents really severe stress.

  At the end of one cycle (each cycle is of 28-3- days)

• Pictorial Blood Loss Assessment Chart (PBAC)

  The Pictorial Blood Loss Assessment Chart (PBAC), a self-administered pictorial assessment chart that assigns scores based on how much tampons and cotton-based sanitary pads stain throughout a menstrual cycle, was given to the patients as a tool to measure their menstrual blood volume. Reliability of the PBAC has been shown. They were given guidelines by the researcher on how to utilize the PBAC. Hypomenorrhea was linked to PBAC scores of 10 or less, regular monthly flow was linked to PBAC scores of 10 to 99, and heavy menstrual bleeding was linked to PBAC scores of 100 or more for two months. Cotton pads were the only sanitary goods used. Software for statistical analysis was used to determine scores.

  At the end of one cycle (each cycle is of 28-3- days)

Study Arms (2)

Control Group

NO INTERVENTION

10 females with no dysmenorrhea participated as controls.

NSAIDs and Aprepitant group (Sequential)

EXPERIMENTAL

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.

Drug: Ibuprofen and Aprepitant

Interventions

Ibuprofen and Aprepitant DRUG

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.

Also known as: NSAIDs, Neurokinin 1 Receptor antagonist

NSAIDs and Aprepitant group (Sequential)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: this is study on primary dysmenorrhea, hence all female participants were enrolled
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The participants must be unmarried women of reproductive age who have moderate to severe dysmenorrhea.
• The participants must experience dysmenorrhea during most menstrual cycles to be included in the study.
• For controls, they must not have dysmenorrhea.

You may not qualify if:

• Those with irregular or infrequent menstrual cycles.
• Women who are taking oral contraceptive pills (OCPs) and using an intrauterine contraceptive device (IUD) excluded from the study.
• Women who have reached menopause or have undergone a surgical procedure resulting in the cessation of menstruation excluded from the study.
• Women who are pregnant or breastfeeding.
• Women who taking any medication like sedatives and NSAIDs.
• Women with PCOs, hysterectomy and uterine carcinoma will not be included.

Sponsors & Collaborators

• Lahore Medical Research Center, LLP: lead

Study Sites (1)

Prof. Dr. Riffat Mehboob

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Interventions

Ibuprofen; Aprepitant; Anti-Inflammatory Agents, Non-Steroidal; Neurokinin-1 Receptor Antagonists

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Group 1: Controls 10 females with no dysmenorrhea participated as controls. Group 2: NSAIDS 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.

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 19, 2024
• Study Start: March 15, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 15, 2024
• Last Updated: February 21, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)