MECOVAC-1: Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine

Sponsor
Università degli Studi dell'Insubria (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05083065
Collaborator
(none)
300
2.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Covid-19 vaccine

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine
Anticipated Study Start Date :
Oct 21, 2021
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Women who underwent Covid-19 vaccination

This group includes women who underwent both the first or complete cycle of Covid-19 vaccination, regardless of the vaccine used.

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)

Outcome Measures

Primary Outcome Measures

  1. Frequency of the menstrual cycle [30 days after the administration of the first and second doses of vaccine]

    In women of reproductive age, any frequency shorter than 25 days or longer than 36 days will be defined as abnormal

  2. Quantity of the menstrual cycle [30 days after the administration of the first and second doses of vaccine]

    In women of reproductive age, any quantity less than 30 ml or more than 80 ml will be defined as abnormal

  3. Duration of the menstrual cycle [30 days after the administration of the first and second doses of vaccine]

    In women of reproductive age, any duration shorter than 3 days or longer than 7 days will be defined as abnormal

Secondary Outcome Measures

  1. Post-menopausal bleeding [30 days after the administration of the first and second doses of vaccine]

    Any bleeding occurred in post-menopausal women

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.
Exclusion Criteria:
  • Women undergoing any kind of hormonal therapy, including combined oral contraceptives, oral/vaginal progestins, intrauterine devices, GnRH-analogues, aromatase inhibitors, hormonal replacement therapy in menopause;

  • Surgical menopause (hysterectomy and/or bilateral oophorectomy);

  • Breastfeeding.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Università degli Studi dell'Insubria

Investigators

  • Principal Investigator: Antonio Simone Laganà, M.D., Ph.D., Università degli Studi dell'Insubria

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Antonio Simone Laganà, Principal Investigator, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT05083065
Other Study ID Numbers:
  • MECOVAC-1
First Posted:
Oct 19, 2021
Last Update Posted:
Oct 26, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Antonio Simone Laganà, Principal Investigator, Università degli Studi dell'Insubria
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2021