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

NCT05083065 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 369

Last updated 2022-11-02

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Università degli Studi dell'Insubria

    lead OTHER

Principal Investigators

  • Antonio Simone Laganà, M.D., Ph.D. · Università degli Studi dell'Insubria

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-10
Primary Completion
2021-10-10
Completion
2021-12-30
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05083065 on ClinicalTrials.gov