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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05083065
Other study ID # MECOVAC-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2021
Est. completion date December 30, 2021

Study information

Verified date October 2022
Source Università degli Studi dell'Insubria
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 369
Est. completion date December 30, 2021
Est. primary completion date October 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Intervention

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)

Locations

Country Name City State
Italy University of Insubria Varese

Sponsors (1)

Lead Sponsor Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Post-menopausal bleeding Any bleeding occurred in post-menopausal women 30 days after the administration of the first and second doses of vaccine
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