COVID-19 Vaccines and the Menstrual Cycle

• Sponsor: University of Jordan (Other)
• Overall Status: Completed
• CT.gov ID: NCT05688995
• Collaborator: (none)
• Enrollment: 617
• Location: 1
• Actual Duration (Months): 15
• Patients Per Site Per Month: 41

Study Details

Study Description

Brief Summary

The study aimed to explore the effect of different COVID-19 vaccines on menstrual cycle

Condition or Disease	Intervention/Treatment	Phase
Menstrual Irregularity	Biological: Naser Al-Husban

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

• Study Type: Observational
• Actual Enrollment: 617 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: COVID-19 Vaccines and the Menstrual Cycle; a Cross-sectional Study
• Actual Study Start Date: Sep 30, 2021
• Actual Primary Completion Date: Dec 30, 2021
• Actual Study Completion Date: Jan 1, 2023

Outcome Measures

Primary Outcome Measures

1. significant changes in the menstrual cycle after vaccination [6 months]

   changes that involve bleeding amount or pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 18 years and older

• less than 40 years

• healthy women

• received covid-19 vaccine

Exclusion Criteria:

• women who did not receive the vaccine

• those living outside Jordan (those cannot fill the form) and during analysis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jordan University Hospital	Amman		Jordan	11941

Sponsors and Collaborators

• University of Jordan

Investigators

• Principal Investigator: Naser U Al-Husban, the University Of Jordan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Naser Al-Husban, Associate Professor, University of Jordan
• ClinicalTrials.gov Identifier: NCT05688995
• Other Study ID Numbers: ju
• First Posted: Jan 18, 2023
• Last Update Posted: Jan 18, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Menstruation Disturbances

Study Results

No Results Posted as of Jan 18, 2023