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NCT05838157
The Effect of HPV Vaccine on Menstrual Cycle in Women of Reproductive Age
trial testing prophylactic HPV vaccine(bivalent HPV、quadrivalent HPV、9-valent HPV) in Menstrual Disorder in 600 participants. Status unknown.
31 May 2024
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 600 |
| Start date | 4 May 2023 |
| Primary completion | 31 May 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 2 locations across China |
Drugs / interventions tested
- prophylactic HPV vaccine(bivalent HPV、quadrivalent HPV、9-valent HPV) — full drug profile →
Conditions studied
- Menstrual Disorder — all drugs for Menstrual Disorder →
- Premature Ovarian Failure — all drugs for Premature Ovarian Failure →
Sponsor
Sun Yat-sen University
Who can join
Adults 16 to 40, female only, with Menstrual Disorder or Premature Ovarian Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05838157 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Yat-sen University
- Last refreshed: 9 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05838157.
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