NCT05083065

Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 369 (actual)
• Sponsor: Università degli Studi dell'Insubria · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Covid-19 vaccines offered a good opportunity to counteract the spread of Sars-Cov-2 infection among the general population, reducing significantly both morbidity and mortality. Nevertheless, after the first and second doses of vaccination (regardless of the type of vaccine used) several women required gynaecological visits claiming menstrual Irregularities or abnormal uterine bleeding. Considering this anecdotal evidence, a questionnaire was designed to investigate systematically whether menstrual Irregularities or abnormal uterine bleeding occurred in a significant percentage of women undergoing first and second doses of covid-19 vaccination.

Conditions

• COVID-19
• Vaccine
• Menstrual Irregularity
• Menopausal Bleeding

Interventions

Type	Name	Description
BIOLOGICAL	Covid-19 vaccine	* First dose or complete cycle of Comirnaty (Pfizer/BioNTech) vaccine * First dose or complete cycle of Spikevax (Moderna) vaccine * First dose or complete cycle of AstraZeneca/Vaxzevria vaccine * Complete cycle of vaccination using one type of vaccine for the first dose and a different type for the second dose * Janssen (Johnson \& Johnson) vaccine (single dose)

Timeline

• Start date: 2021-09-10
• Primary completion: 2021-10-10
• Completion: 2021-12-30
• First posted: 2021-10-19
• Last updated: 2022-11-02

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study