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OpenTrials
Completed

NCT Number: NCT05083065

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Menopausal Bleeding Menstrual Irregularity Menstruation Disturbances Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccine Virus Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Insubria

Varese, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. Frequency of the menstrual cycle

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Post-menopausal bleeding

    Time frame: 30 days after the administration of the first and second doses of vaccine

    Any bleeding occurred in post-menopausal women

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Registry information

Acronym: MECOVAC-1

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 19, 2021
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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