Primary DysmenorrheaNCT06359457
Correlation Between Serum Progesterone Level And Primary Dysmenorrhea
An observational study of Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to determine the correlation between the levels of serum progesterone and Menstrual Symptoms In Young Females with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 17 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 5 May 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: One hundred girls with dysmenorrhoea. Menarche at least 3 years ago. All females should be regular menstrual cycles.
Who may be able to join
- One hundreds adult females were suffered from primary dysmenorrhea.
- Their age was ranged from 17 to 24 years.
- Their body mass index was ranged from 20 to 25 kg/m2.
Who cannot join
- Any participant will be excluded from the study if they have:
- Irregulars or infrequent menstrual cycles.
- Pacemaker, Myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis.
- Pelvic pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Serum Progesterone Level And Menstrual Symptoms In Young Females With Primary Dysmenorrhea
This study will be conducted to determine the correlation between the levels of serum progesterone and Menstrual Symptoms In Young Females with primary dysmenorrhea.
Read the detailed description
One hundred adult females with primary dysmenorrhea will participate in this study. They will be recruited from the Gynaecological outpatient clinic, Kasr El Ainy University Hospital, Cairo, 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 females with primaryf dysmenorrhea.
- Conditions
- Primary Dysmenorrhea
- Keywords
- Dysmenorrhoea, Serum progesterone level, Visual analogue scale, Menstrual symptoms questionnaire
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A group of young females with primary dysmenorrhea | One hundred young females with primary dysmenorrhea will participate in this study. They will be recruited from the Gynecological outpatient clinic, Kasr El Ainy University Hospital, Cairo, Egypt. All females should have regular menstrual cycles. Taking blood samples of 3 ml through the cubital vein to examine the levels of serum progesterone will be carried out on the 21st day of menstruation, while to assess the pain intensity of primary dysmenorrhea using the Visual Analogue Scale (VAS) and physical and psychological symptoms associated with dysmenorrhea will be assessed by menstrual symptoms questionnaire . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 4-20 ng
Measured: 1 month
Pain intensity
It will be measured by Visual analogue scale. It is 10 cm line with values ranging from 0 to 10. 0 indicates no pain nd 10 indicates the worst pain.
Measured: 1 month
Physical and psychological menstrual symptoms
It will be measured by menstrual symptoms questionnaire. It is 25 items split into two categories 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
Measured: 1 month
Correlation between serum progesterone level and pain
The correlation between serum progesterone level and pain intensity measured by the VAS will be conducted
Measured: 1 month
Correlation between serum progesterone level and menstrual symptoms
The correlation between serum progesterone level and menstrual symptoms measured by the menstrual symptom questionnaire will be conducted
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start5 May 2024
- Primary completion15 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennaallah Yousef Mohamed Nasreldien, Cairo University
- Investigators
- HANAA HAFEZ, PhD, Study director, Lecturer of Physical Therapy for Orthopedic. Physical Therapy, Nahda University.RANIA Hamed, PhD, Study director, Lecturer of Physical Therapy for Basic Science. Physical Therapy, Nahda University.ESRAA MOHAMED, PhD, Study director, Lecturer Of Physical Therapy For Cardiovascular, Respiratory and Geriatrics.HOSSAM HUSSIEN, PhD, Study director, Faculty of Medicine, Al-Azhar University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359457
- Sponsor's protocol ID
- P.T.REC/012/005016
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Serum Progesterone Level And Menstrual Symptoms In Young Females With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06359457
- Acronym / sponsor ID
- P.T.REC/012/005016
- Conditions
- Primary Dysmenorrhea
- Keywords
- Dysmenorrhoea, Serum progesterone level, Visual analogue scale, Menstrual symptoms questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to determine the correlation between the levels of serum progesterone and Menstrual Symptoms In Young Females with primary dysmenorrhea.
Detailed description
One hundred adult females with primary dysmenorrhea will participate in this study. They will be recruited from the Gynaecological outpatient clinic, Kasr El Ainy University Hospital, Cairo, 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 females with primaryf dysmenorrhea.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A group of young females with primary dysmenorrhea | – | –One hundred young females with primary dysmenorrhea will participate in this study. They will be recruited from the Gynecological outpatient clinic, Kasr El Ainy University Hospital, Cairo, Egypt. All females should have regular menstrual cycles. Taking blood samples of 3 ml through the cubital vein to examine the levels of serum progesterone will be carried out on the 21st day of menstruation, while to assess the pain intensity of primary dysmenorrhea using the Visual Analogue Scale (VAS) and physical and psychological symptoms associated with dysmenorrhea will be assessed by menstrual symptoms questionnaire . |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- One hundred girls with dysmenorrhoea. Menarche at least 3 years ago. All females should be regular menstrual cycles.
Key inclusion criteria (3 listed)
- One hundreds adult females were suffered from primary dysmenorrhea.
- Their age was ranged from 17 to 24 years.
- Their body mass index was ranged from 20 to 25 kg/m2.
Key exclusion criteria (4 listed)
- Any participant will be excluded from the study if they have:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum progesterone level
Time frame: 1 month
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 4-20 ng
Pain intensity
Time frame: 1 month
It will be measured by Visual analogue scale. It is 10 cm line with values ranging from 0 to 10. 0 indicates no pain nd 10 indicates the worst pain.
Physical and psychological menstrual symptoms
Time frame: 1 month
It will be measured by menstrual symptoms questionnaire. It is 25 items split into two categories 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
Correlation between serum progesterone level and pain
Time frame: 1 month
The correlation between serum progesterone level and pain intensity measured by the VAS will be conducted
Correlation between serum progesterone level and menstrual symptoms
Time frame: 1 month
The correlation between serum progesterone level and menstrual symptoms measured by the menstrual symptom questionnaire will be conducted
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HANAA HAFEZ, PhD study director
Lecturer of Physical Therapy for Orthopedic. Physical Therapy, Nahda University.
RANIA Hamed, PhD study director
Lecturer of Physical Therapy for Basic Science. Physical Therapy, Nahda University.
ESRAA MOHAMED, PhD study director
Lecturer Of Physical Therapy For Cardiovascular, Respiratory and Geriatrics.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum progesterone level (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.