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The Effect of HPV Vaccine on Menstrual Cycle in Women of Reproductive Age

NCT05838157 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2023-06-09

No results posted yet for this study

Summary

Cervical cancer is one of the most common cancer in women, making it the fourth largest cause of female cancer mortality worldwide. High-risk HPV types (hrHPV) continuous infection is the main cause of the premalignant and malignant lesions of the cervix. The most effective primary prevention of cervical cancer is administration HPV vaccines. There are three prophylactic HPV vaccines including bivalent HPV (2vHPV)， quadrivalent HPV vaccine (4vHPV)，9-valent HPV vaccine (9vHPV) currently. With the widespread of HPV vaccination， the cases related to abnormal menstrual cycle or menstrual irregularities has gradually increased in the Vaccine Adverse Event Reporting System, also the number of reports and studies were increasing. We designed this study to evaluate the statistical association of HPV vaccine and changes in menstrual cycle or menstrual irregularities、amenorrhea. And detect the signal of premature ovarian insufficiency (POI) and related events of three HPV vaccines, and to provide evidence for the safety of HPV vaccines based on the data mining and signal detection method. The research data was obtained from prospective self- developed questionnaire. Before-after study was applied in this study, investigators collect the menstrual cycle data of subjects by the questionnaire and qualitatively interview were taken. The control group is before vaccination, HPV vaccination is Intervention group.

Conditions

  • Menstrual Disorder
  • Premature Ovarian Failure

Interventions

BIOLOGICAL

prophylactic HPV vaccine(bivalent HPV、quadrivalent HPV、9-valent HPV)

at least one dose of prophylactic HPV vaccine including bivalent HPV (2vHPV)， quadrivalent HPV vaccine (4vHPV)，9-valent HPV vaccine (9vHPV)

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Juan Xiao, Master · Sun Yat-sen University

  • Chuanbo Xie, PhD · Sun Yat-sen University

  • Junjie Chen, Bachelor · Sun Yat-sen University

  • Huiping Ye, Bachelor · Sun Yat-sen University

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2024-05-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05838157 on ClinicalTrials.gov