COVID-19MECOVAC-1NCT05083065
Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine
An observational study of COVID-19 and Vaccine, run by Università degli Studi dell'Insubria at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Vaccine, Menstrual Irregularity
- What is being tested?
- Covid-19 vaccine
- Type of treatment
- Vaccines
- How many people
- 369 participants
- Where
- 1 siteItaly
- Study dates
- 10 Sep 2021to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.
Who may be able to join
- Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Covid-19 vaccine
- Keywords
- Covid-19 vaccine, Menstrual Irregularity, Menopausal Bleeding
- Medical subject headings
- COVID-19, Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Covid-19 vaccineBiological
- 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Covid-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 30 days after the administration of the first and second doses of vaccine
Secondary outcomes (1)
Post-menopausal bleeding
Any bleeding occurred in post-menopausal women
Measured: 30 days after the administration of the first and second doses of vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start10 Sep 2021
- Primary completion10 Oct 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Antonio Simone Laganà, M.D., Ph.D., Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083065
- Sponsor's protocol ID
- MECOVAC-1
- Acronym
- MECOVAC-1
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Menstrual Irregularities and Abnormal Uterine Bleeding After Covid-19 Vaccine
- ClinicalTrials.gov ID
- NCT05083065
- Acronym / sponsor ID
- MECOVAC-1 / MECOVAC-1
- Conditions
- COVID-19, Vaccine, Menstrual Irregularity, Menopausal Bleeding
- Keywords
- Covid-19 vaccine, Menstrual Irregularity, Menopausal Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 10 Oct 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women who underwent Covid-19 vaccination | – | Biological: Covid-19 vaccineThis group includes women who underwent both the first or complete cycle of Covid-19 vaccination, regardless of the vaccine used. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.
Key inclusion criteria (1 listed)
- Women who underwent first dose or complete cycle of covid-19 vaccine, regardless of the type of vaccine used.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Biological | Women who underwent Covid-19 vaccination |
Primary outcome
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
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
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
1 secondary outcome
Post-menopausal bleeding
Time frame: 30 days after the administration of the first and second doses of vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Simone Laganà, M.D., Ph.D. principal investigator
Università degli Studi dell'Insubria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Vaccine, run by Università degli Studi dell'Insubria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of the menstrual cycle (time frame: 30 days after the administration of the first and second doses of vaccine). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.