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Trial record 1 of 3 for:    menstruation | Covid-19 vaccine
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Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine (MECOVAC-1)

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ClinicalTrials.gov Identifier: NCT05083065
Recruitment Status : Not yet recruiting
First Posted : October 19, 2021
Last Update Posted : October 26, 2021
Sponsor:
Information provided by (Responsible Party):
Antonio Simone Laganà, Università degli Studi dell'Insubria

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
COVID-19 Vaccine Menstrual Irregularity Menopausal Bleeding Biological: Covid-19 vaccine

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

Resource links provided by the National Library of Medicine


Group/Cohort 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)




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05083065


Contacts
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Contact: Antonio Simone Laganà, M.D., Ph.D. +393296279579 antoniosimone.lagana@uninsubria.it

Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
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Principal Investigator: Antonio Simone Laganà, M.D., Ph.D. Università degli Studi dell'Insubria
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Responsible Party: Antonio Simone Laganà, Principal Investigator, Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier: NCT05083065    
Other Study ID Numbers: MECOVAC-1
First Posted: October 19, 2021    Key Record Dates
Last Update Posted: October 26, 2021
Last Verified: October 2021

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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, Università degli Studi dell'Insubria:
Covid-19 vaccine
Menstrual Irregularity
Menopausal Bleeding
Additional relevant MeSH terms:
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COVID-19
Menstruation Disturbances
Uterine Hemorrhage
Hemorrhage
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Uterine Diseases