Menstrual IrregularityNCT05688995
COVID-19 Vaccines and the Menstrual Cycle
An observational study of Menstrual Irregularity, run by University of Jordan at 1 site in Jordan.
Trial summary
The study aimed to explore the effect of different COVID-19 vaccines on menstrual cycle Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Irregularity
- What is being tested?
- Naser Al-Husban
- Type of treatment
- Vaccines
- How many people
- 617 participants
- Where
- 1 siteJordan
- Study dates
- 30 Sep 2021to 1 Jan 2023
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Our study included 617 Menstruating females. 74.55% of participants were of the age group between 20-35 years. 59.64% had normal BMI (18.5-24.9 Kg/m2), while 11.99% were underweight (BMI less than 18.5 Kg/m2), 19.77% were overweight (BMI>24.9 Kg/m2 but less than 30 Kg/m2), and 8.59% were obese (BMI more than 30 Kg/m2). Largest BMI was 39.79 Kg/m2. Most of participants were single ladies (79.25%). 82.01% were nulliparous. 17.83% were multiparous, including 1.62% ladies that had 5 or more children (grand multiparous).
Who may be able to join
- 18 years and older
- less than 40 years
- healthy women
- received covid-19 vaccine
Who cannot join
- women who did not receive the vaccine
- those living outside Jordan (those cannot fill the form) and during analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Vaccines and the Menstrual Cycle; a Cross-sectional Study
The study aimed to explore the effect of different COVID-19 vaccines on menstrual cycle
Read the detailed description
This is a descriptive cross-sectional study that took place between September 2021 and December 2021. The study aimed to explore the effect of different COVID-19 vaccines on menstrual cycle. It used an anonymous questionnaire distributed via social media platforms; Facebook, Twitter, and WhatsApp across different cities of Jordan. A total of 732 responses were received with a 59% response rate.
The questionnaire was distributed over four months directed at women who have received at least one dose of the COVID-19 vaccine and who live in Jordan. It took 10 minutes to complete all the questions.
Data collection did not involve direct contact with participants to prevent the spread of COVID-19.
- Conditions
- Menstrual Irregularity
- Being tested
- Naser Al-Husban
- Medical subject headings
- Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naser Al-HusbanBiological
COVID-19 vaccines
What is being measured
The primary outcome is the main question the study is designed to answer.
significant changes in the menstrual cycle after vaccination
changes that involve bleeding amount or pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start30 Sep 2021
- Primary completion30 Dec 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual IrregularityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 617 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naser Al-Husban, University of Jordan
- Investigators
- Naser U Al-Husban, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688995
- Sponsor's protocol ID
- ju
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: can be shared with reasonable request from the primary investigator
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Vaccines and the Menstrual Cycle; a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05688995
- Acronym / sponsor ID
- ju
- Conditions
- Menstrual Irregularity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 18 Jan 2023 (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.
The study aimed to explore the effect of different COVID-19 vaccines on menstrual cycle
Detailed description
This is a descriptive cross-sectional study that took place between September 2021 and December 2021. The study aimed to explore the effect of different COVID-19 vaccines on menstrual cycle. It used an anonymous questionnaire distributed via social media platforms; Facebook, Twitter, and WhatsApp across different cities of Jordan. A total of 732 responses were received with a 59% response rate.
The questionnaire was distributed over four months directed at women who have received at least one dose of the COVID-19 vaccine and who live in Jordan. It took 10 minutes to complete all the questions.
Data collection did not involve direct contact with participants to prevent the spread of COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Our study included 617 Menstruating females. 74.55% of participants were of the age group between 20-35 years. 59.64% had normal BMI (18.5-24.9 Kg/m2), while 11.99% were underweight (BMI less than 18.5 Kg/m2), 19.77% were overweight (BMI>24.9 Kg/m2 but less than 30 Kg/m2), and 8.59% were obese (BMI more than 30 Kg/m2). Largest BMI was 39.79 Kg/m2. Most of participants were single ladies (79.25%). 82.01% were nulliparous. 17.83% were multiparous, including 1.62% ladies that had 5 or more children (grand multiparous).
Key inclusion criteria (4 listed)
- 18 years and older
- less than 40 years
- healthy women
- received covid-19 vaccine
Key exclusion criteria (2 listed)
- women who did not receive the vaccine
- those living outside Jordan (those cannot fill the form) and during analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naser Al-HusbanCOVID-19 vaccines | Biological | – |
Primary outcome
significant changes in the menstrual cycle after vaccination
Time frame: 6 months
changes that involve bleeding amount or pain
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 18 Jan 2023.
- Individual participant dataSharing planned: Undecided. can be shared with reasonable request from the primary investigator
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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.
Naser U Al-Husban principal investigator
University of Jordan
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 Menstrual Irregularity, run by University of Jordan at 1 site in Jordan.
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 4 inclusion and 2 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 18 Jan 2023. 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 Jordan. 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?
significant changes in the menstrual cycle after vaccination (time frame: 6 months). 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 18 Jan 2023.