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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06359457
Other study ID # P.T.REC/012/005016
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date July 2024

Study information

Verified date April 2024
Source Cairo University
Contact MENNAALLAH YOUSEF NASRELDIEN, PhD
Phone 01142896492
Email mennatullahyousef@pt.suez.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will be conducted to determine Correlation between the levels of serum progesterone and Menstrual Symptoms In Young Females


Description:

One hundred adult females with primary dysmenorrhea will participate in this study. They will be recruited from outpatient clinic of Gynaecological outpatient clinic, faculty of physical therapy, Cairo university, Egypt Many studies reported that primary dysmenorrhea was the result of increased prostaglandin, especially prostaglandin F2α (PGF2α) and prostaglandin E2 (PGE2) which produced the effect through the cyclooxygenase pathway, and further led to uterine ischemia hypoxia. Nevertheless the relationship between the serum progesterone level and menstrual symptoms was not completely clear. Hence, this study will investigate the association between the serum progesterone level and menstrual symptoms in young female complain of dysmenorrhea and non-dysmenorrhea.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date July 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 17 Years to 24 Years
Eligibility Inclusion Criteria: 1. One hundreds adult females were suffered from primary dysmenorrhea. 2. Their age was ranged from 17 to 24 years. 3. Their body mass index was ranged from 20 to 25 kg/m2. Exclusion Criteria: - Any participant will be excluded from the study if they have: 1. Irregulars or infrequent menstrual cycles. 2. Pacemaker, Myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis. 3. Pelvic pathology.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Serum progesterone level Blood samples will be taken by physician for each girl, and will send to laboratory center to measure the progesterone level in the blood. The normal serum progesterone level at 21st day is 4-20ng Up to 3 months
Primary Pain intensity It will be measured by Visual analogue scale. It is a graphic rating scale with numerical values placed equidistantly along the line. The descriptors and numbers help the subject to place her estimate on line in which 0 mean no pain,1 equal mild pain, 2 equal moderate pain, 3 mean sever pain and 4 mean unbearable pain. Up to 3 months
Primary Physical and psychological symptoms It will be measured by menstrual symptoms questionnaire. It was 13 item of 22 item of c-form MSQ (CMSQ) which used to assess the physical and psychological symptoms associated with dysmenorrhea.The score on each item ranged from 1 (never) to 5 (always) with a higher composite score indicating more symptoms Up to 3 months
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