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

NCT05083065 | Completed FDA Drug

• 1 other identifier: MECOVAC-1
• Study Type: observational
• Target: 369
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Vaccine; Menstrual Irregularity; Menopausal Bleeding

Keywords

Covid-19 vaccine; Menstrual Irregularity; Menopausal Bleeding

Outcome Measures

Primary Outcomes (3)

• Frequency of the menstrual cycle

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

  30 days after the administration of the first and second doses of vaccine

• Quantity of the menstrual cycle

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

  30 days after the administration of the first and second doses of vaccine

• Duration of the menstrual cycle

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

  30 days after the administration of the first and second doses of vaccine

Secondary Outcomes (1)

• Post-menopausal bleeding

  30 days after the administration of the first and second doses of vaccine

Study Arms (1)

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

Interventions

Covid-19 vaccine BIOLOGICAL

* 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)

Women who underwent Covid-19 vaccination

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.

You may qualify if:

• Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

University of Insubria

Varese, Italy

Location

MeSH Terms

Conditions

COVID-19; Menstruation Disturbances

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Antonio Simone Laganà, M.D., Ph.D.

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: October 19, 2021
• Study Start: September 10, 2021
• Primary Completion: October 10, 2021
• Study Completion: December 30, 2021
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

IT (1)