Menstrual DisorderNCT05838157
The Effect of HPV Vaccine on Menstrual Cycle in Women of Reproductive Age
An observational study of Menstrual Disorder and Premature Ovarian Failure, run by Sun Yat-sen University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Disorder, Premature Ovarian Failure
- What is being tested?
- prophylactic HPV vaccine(bivalent HPV、quadrivalent HPV、9-valent HPV)
- Type of treatment
- Vaccines
- How many people
- 600 participants
- Where
- 2 sitesChina
- Study dates
- 4 May 2023to 31 Dec 2024
- 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 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Girls and women aged 16 to 40 years who receiving HPV vaccination ( including 2vHPV、4vHPV、9vHPV) in Cancer Prevention Center, Sun Yat-sen University Cancer Center during April 10th 2023 to April 30th 2023.
Who may be able to join
- Previous menstrual cycles were regular and normal
- At least one vaccination of HPV vaccine
Who cannot join
- Pregnancy
- Breast-feeding
- Record of abnormal results of HPV test/ cervical cytology/ gynecological ultrasonography
- Record of medications related to menstruation
- Diseases contribute to menstrual irregularities、amenorrhea such as severe anemia/ coagulation disorders/ thyroid dysfunction etc.
- Participation in other clinical trials
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Cancer Prevention Center,Sun Yat-sen University Cancer Cente
Guangzhou, Guangdong, 510000
XIAO Juan, Master, 87345515 ext. 020, xiaojuan@sysucc.org.cn
XIAO Juan, Master
- Not yet recruiting
Sun Yat-sen University Cancer Cente
Guangzhou, Guangdong, 510000
Juan Xiao, Master, 87345515 ext. 020, xiaojuan@sysucc.org.cn
About this study
Official title: Research for the Effect of HPV Vaccine on Menstrual Cycle in Women of Reproductive Age
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.
Read the detailed description
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. Whereas all of the studies are retrospective and the data from passive surveillance system, meanwhile, HPV vaccines has been available in Chinese mainland less than 7 years. Especially, 9vHPV applicable range was broadened to 45 years shortly before. There are rarely prospective researches focus on the connection between HPV vaccines and menstrual disorder. We designed this prospective study to observe and evaluate the statistical association of HPV vaccine and menstrual disorder such as menstrual irregularities、amenorrhea、 hypomenorrhea or hypermenorrhea in Chinese women. 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 study design used self-control, We using a self-designed questionnaire collect the menstruation data of girls and women aged 16 to 40 years who receiving HPV vaccination ( including 2vHPV、4vHPV、9vHPV) in Cancer Prevention Center, Sun Yat-sen University Cancer Center during May 10th 2023 to April 30th 2023. The self-designed questionnaire contains three parts. First part includes personal basic information such as age, profession, education Level, marital or childbearing status etc. Part two there are containing health status, menstruation conditions (include menstrual cycle, menstrual period, menstrual blood volume and dysmenorrhea etc). Part three collects menstruation conditions by qualitatively interview , covers each menstrual cycle after the first dose of HPV vaccination until 3 months after the third dose .
To analyze the data, R studio statistical software was used. The general measurement data were analyzed by paired sample T test, p=0.05. Bayesian trusted Propagation neural network (BCPNN) and multi-item gamma Poisson contractor (MGPS) were used to detect the signals of POI related events and to conduct empirical Bayes data mining among ours database.
- Conditions
- Menstrual Disorder, Premature Ovarian Failure
- Being tested
- prophylactic HPV vaccine(bivalent HPV、quadrivalent HPV、9-valent HPV)
- Keywords
- HPV vaccine, menstrual cycle, menstrual disorder, premature ovarian insufficiency
- Medical subject headings
- Menstruation Disturbances, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylactic HPV vaccine(bivalent HPV、quadrivalent HPV、9-valent HPV)Biological
at least one dose of prophylactic HPV vaccine including bivalent HPV (2vHPV)， quadrivalent HPV vaccine (4vHPV)，9-valent HPV vaccine (9vHPV)
| Study group | Role | What they receive |
|---|---|---|
| Girls and women aged 16 to 40 years who receiving at least one dose of HPV vaccination | Girls and women aged 16 to 40 years who receiving HPV vaccination ( including 2vHPV、4vHPV、9vHPV) in Cancer Prevention Center, Sun Yat-sen University Cancer Center during April 10th 2023 to April 30th 2023. Receives: Biological: prophylactic HPV vaccine(bivalent HPV、quadrivalent HPV、9-valent HPV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of the menstrual cycle
In 16~40 years old women , any frequency shorter than 21 days or longer than 36 days will be defined as abnormal
Measured: 3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)
Duration of the menstrual cycle
In 16~40 years old women , any duration shorter than 3 days or longer than 7 days will be defined as abnormal
Measured: 3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)
Quantity of the menstrual cycle
In 16~40 years old women , any quantity less than 30 ml or more than 80 ml will be defined as abnormal
Measured: 3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)
Secondary outcomes (1)
Premature ovarian failure (POF) signals
From the first dose of the vaccine, Blood biochemical detection used to measure the levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), progesterone (P), testosterone (T) and prolactin (PRL). And Ultrasonography is used to detected changes in the endometrium after each vaccination.
Measured: 3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start4 May 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Menstrual DisorderStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Juan, Sun Yat-sen University
- Investigators
- Juan Xiao, Master, Study director, Sun Yat-sen UniversityChuanbo Xie, PhD, Study director, Sun Yat-sen UniversityJunjie Chen, Bachelor, Principal investigator, Sun Yat-sen UniversityHuiping Ye, Bachelor, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838157
- Sponsor's protocol ID
- 2022111615154477
- Status last verified
- Jun 2023
- First submitted
- 3 Apr 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338de Sanjose S, Delany-Moretlwe S. HPV vaccines can be the hallmark of cancer prevention. Lancet. 2019 Aug 10;394(10197):450-451. doi: 10.1016/S0140-6736(19)30549-5. Epub 2019 Jun 26. No abstract available.
PubMed 31255298Gong L, Ji HH, Tang XW, Pan LY, Chen X, Jia YT. Human papillomavirus vaccine-associated premature ovarian insufficiency and related adverse events: data mining of Vaccine Adverse Event Reporting System. Sci Rep. 2020 Jul 1;10(1):10762. doi: 10.1038/s41598-020-67668-1.
PubMed 32612121Hviid A, Myrup Thiesson E. Association Between Human Papillomavirus Vaccination and Primary Ovarian Insufficiency in a Nationwide Cohort. JAMA Netw Open. 2021 Aug 2;4(8):e2120391. doi: 10.1001/jamanetworkopen.2021.20391.
PubMed 34436612Colafrancesco S, Perricone C, Tomljenovic L, Shoenfeld Y. Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants. Am J Reprod Immunol. 2013 Oct;70(4):309-16. doi: 10.1111/aji.12151. Epub 2013 Jul 31.
PubMed 23902317Tatang C, Arredondo Bisono T, Bergamasco A, Salvo F, Costa Clemens SA, Moride Y. Human Papillomavirus Vaccination and Premature Ovarian Failure: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System. Drugs Real World Outcomes. 2022 Mar;9(1):79-90. doi: 10.1007/s40801-021-00271-6. Epub 2021 Sep 12.
PubMed 34510402Torella M, Marrapodi MM, Ronsini C, Ruffolo AF, Braga A, Frigerio M, Amabile E, Vastarella MG, Rossi F, Riemma G. Risk of Premature Ovarian Insufficiency after Human Papilloma Virus Vaccination: A PRISMA Systematic Review and Meta-Analysis of Current Evidence. Vaccines (Basel). 2023 Jan 9;11(1):140. doi: 10.3390/vaccines11010140.
PubMed 36679985Little DT, Ward HR. Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination: A Case Series Seen in General Practice. J Investig Med High Impact Case Rep. 2014 Oct 28;2(4):2324709614556129. doi: 10.1177/2324709614556129. eCollection 2014 Oct-Dec.
PubMed 26425627
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research for the Effect of HPV Vaccine on Menstrual Cycle in Women of Reproductive Age
- ClinicalTrials.gov ID
- NCT05838157
- Acronym / sponsor ID
- 2022111615154477
- Conditions
- Menstrual Disorder, Premature Ovarian Failure
- Keywords
- HPV vaccine, menstrual cycle, menstrual disorder, premature ovarian insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 May 2023 (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.
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.
Detailed description
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. Whereas all of the studies are retrospective and the data from passive surveillance system, meanwhile, HPV vaccines has been available in Chinese mainland less than 7 years. Especially, 9vHPV applicable range was broadened to 45 years shortly before. There are rarely prospective researches focus on the connection between HPV vaccines and menstrual disorder. We designed this prospective study to observe and evaluate the statistical association of HPV vaccine and menstrual disorder such as menstrual irregularities、amenorrhea、 hypomenorrhea or hypermenorrhea in Chinese women. 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 study design used self-control, We using a self-designed questionnaire collect the menstruation data of girls and women aged 16 to 40 years who receiving HPV vaccination ( including 2vHPV、4vHPV、9vHPV) in Cancer Prevention Center, Sun Yat-sen University Cancer Center during May 10th 2023 to April 30th 2023. The self-designed questionnaire contains three parts. First part includes personal basic information such as age, profession, education Level, marital or childbearing status etc. Part two there are containing health status, menstruation conditions (include menstrual cycle, menstrual period, menstrual blood volume and dysmenorrhea etc). Part three collects menstruation conditions by qualitatively interview , covers each menstrual cycle after the first dose of HPV vaccination until 3 months after the third dose .
To analyze the data, R studio statistical software was used. The general measurement data were analyzed by paired sample T test, p=0.05. Bayesian trusted Propagation neural network (BCPNN) and multi-item gamma Poisson contractor (MGPS) were used to detect the signals of POI related events and to conduct empirical Bayes data mining among ours database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Girls and women aged 16 to 40 years who receiving at least one dose of HPV vaccination | – | Biological: prophylactic HPV vaccine(bivalent HPV、quadrivalent HPV、9-valent HPV)Girls and women aged 16 to 40 years who receiving HPV vaccination ( including 2vHPV、4vHPV、9vHPV) in Cancer Prevention Center, Sun Yat-sen University Cancer Center during April 10th 2023 to April 30th 2023. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Girls and women aged 16 to 40 years who receiving HPV vaccination ( including 2vHPV、4vHPV、9vHPV) in Cancer Prevention Center, Sun Yat-sen University Cancer Center during April 10th 2023 to April 30th 2023.
Key inclusion criteria (2 listed)
- Previous menstrual cycles were regular and normal
- At least one vaccination of HPV vaccine
Key exclusion criteria (6 listed)
- Pregnancy
- Breast-feeding
- Record of abnormal results of HPV test/ cervical cytology/ gynecological ultrasonography
- Record of medications related to menstruation
- Diseases contribute to menstrual irregularities、amenorrhea such as severe anemia/ coagulation disorders/ thyroid dysfunction etc.
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 |
|---|---|---|
| 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) | Biological | Girls and women aged 16 to 40 years who receiving at least one dose of HPV vaccination |
Primary outcome
Frequency of the menstrual cycle
Time frame: 3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)
In 16~40 years old women , any frequency shorter than 21 days or longer than 36 days will be defined as abnormal
Duration of the menstrual cycle
Time frame: 3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)
In 16~40 years old women , any duration shorter than 3 days or longer than 7 days will be defined as abnormal
Quantity of the menstrual cycle
Time frame: 3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)
In 16~40 years old women , any quantity less than 30 ml or more than 80 ml will be defined as abnormal
1 secondary outcome
Premature ovarian failure (POF) signals
Time frame: 3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Results publication: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Results publication: PubMed 31255298de Sanjose S, Delany-Moretlwe S. HPV vaccines can be the hallmark of cancer prevention. Lancet. 2019 Aug 10;394(10197):450-451. doi: 10.1016/S0140-6736(19)30549-5. Epub 2019 Jun 26. No abstract available.
- Results publication: PubMed 32612121Gong L, Ji HH, Tang XW, Pan LY, Chen X, Jia YT. Human papillomavirus vaccine-associated premature ovarian insufficiency and related adverse events: data mining of Vaccine Adverse Event Reporting System. Sci Rep. 2020 Jul 1;10(1):10762. doi: 10.1038/s41598-020-67668-1.
- Results publication: PubMed 34436612Hviid A, Myrup Thiesson E. Association Between Human Papillomavirus Vaccination and Primary Ovarian Insufficiency in a Nationwide Cohort. JAMA Netw Open. 2021 Aug 2;4(8):e2120391. doi: 10.1001/jamanetworkopen.2021.20391.
- Results publication: PubMed 23902317Colafrancesco S, Perricone C, Tomljenovic L, Shoenfeld Y. Human papilloma virus vaccine and primary ovarian failure: another facet of the autoimmune/inflammatory syndrome induced by adjuvants. Am J Reprod Immunol. 2013 Oct;70(4):309-16. doi: 10.1111/aji.12151. Epub 2013 Jul 31.
- Results publication: PubMed 34510402Tatang C, Arredondo Bisono T, Bergamasco A, Salvo F, Costa Clemens SA, Moride Y. Human Papillomavirus Vaccination and Premature Ovarian Failure: A Disproportionality Analysis Using the Vaccine Adverse Event Reporting System. Drugs Real World Outcomes. 2022 Mar;9(1):79-90. doi: 10.1007/s40801-021-00271-6. Epub 2021 Sep 12.
- Results publication: PubMed 36679985Torella M, Marrapodi MM, Ronsini C, Ruffolo AF, Braga A, Frigerio M, Amabile E, Vastarella MG, Rossi F, Riemma G. Risk of Premature Ovarian Insufficiency after Human Papilloma Virus Vaccination: A PRISMA Systematic Review and Meta-Analysis of Current Evidence. Vaccines (Basel). 2023 Jan 9;11(1):140. doi: 10.3390/vaccines11010140.
- Results publication: PubMed 26425627Little DT, Ward HR. Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination: A Case Series Seen in General Practice. J Investig Med High Impact Case Rep. 2014 Oct 28;2(4):2324709614556129. doi: 10.1177/2324709614556129. eCollection 2014 Oct-Dec.
- Individual participant dataSharing planned: Undecided
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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.
Juan Xiao, Master study director
Sun Yat-sen University
Chuanbo Xie, PhD study director
Sun Yat-sen University
Junjie Chen, Bachelor principal investigator
Sun Yat-sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Disorder and Premature Ovarian Failure, run by Sun Yat-sen University at 2 sites in China.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Xiao, Master (87345515 ext. 020, xiaojuan@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of the menstrual cycle (time frame: 3 months after the administration of the third dose of vaccine( starts with the first dose of HPVvaccine, no less than 9 cycles)). 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?
On the ClinicalTrials.gov record for NCT05838157, which also lists 8 linked publications.
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 9 Jun 2023.