Pelvic PainNCT03786588
Patients With Chronic Pelvic Pain With Vaginal Microbiota
An observational study of Pelvic Pain, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Vaginal microorganisms play an important role in the occurrence and development of many diseases, such as persistent infection of high-risk human papillomavirus (HR-HPV) causing cervical intraepithelial neoplasia and cervical cancer, and the role of microorganisms in chronic prostatitis. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Pelvic Pain
- What is being tested?
- Observation
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2018to 25 Dec 2020
- How long will I take part?
- 1 Year
- 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 20 to 45 years
- Men only
- Adult
Study population: Gestational participants without HPV infection
Who may be able to join
- Those are aged 20 to 45 years old, have vaginal intercourse more than 3 years, and aren't in menstrual, pregnancy or puerperium period.
Who cannot join
- Those are aged more than 45 years old without HPV infection in the last one year, having no vaginal intercourse, and those can't cooperate the examiner. Women who are HIV or hepatitis B/C positive, have autoimmune disorders and systemic disease (like diabetes mellitus, hormone treatment diseases, severe liver and kidney dysfunction), or have severe mental illness and malignant tumors are also excluded. At the same time, all the participants should meet the following requirements: no vagina douching within last 2 days, no vaginal intercourse within last 3 days, no systemic application of antifungal agents or antibiotics or pessaries within last 14 days of sampling.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Hui Xu, +86-010-69156874
About this study
Official title: Chronic Pelvic Pain With Vaginal Microbiota in Gestational Women Without HPV Infection
Vaginal microorganisms play an important role in the occurrence and development of many diseases, such as persistent infection of high-risk human papillomavirus (HR-HPV) causing cervical intraepithelial neoplasia and cervical cancer, and the role of microorganisms in chronic prostatitis.
- Conditions
- Pelvic Pain
- Being tested
- Observation
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
The patients with the negative results of HPV infection, and assigned to different group according to the CPP manifestation.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Vaginal microbiota in gestation CPP women without HPV infection Receives: Other: Observation | |
| GroupB | Vaginal microbiota in gestation women without CPP and HPV infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal microbiota difference
Vaginal microbiota difference between the women with or without CPP, and all the cases are cervical HPV negative.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start25 Dec 2018
- Primary completion25 Dec 2019 (estimated)
- Study completion25 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shuwang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786588
- Sponsor's protocol ID
- CPPVM
- Status last verified
- Aug 2019
- First submitted
- 21 Dec 2018
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pelvic Pain With Vaginal Microbiota in Gestational Women Without HPV Infection
- ClinicalTrials.gov ID
- NCT03786588
- Acronym / sponsor ID
- CPPVM
- Conditions
- Pelvic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 25 Dec 2018 (actual)
- Primary completion
- 25 Dec 2019 (estimated)
- Study completion
- 25 Dec 2020 (estimated)
- First posted
- 26 Dec 2018 (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.
Vaginal microorganisms play an important role in the occurrence and development of many diseases, such as persistent infection of high-risk human papillomavirus (HR-HPV) causing cervical intraepithelial neoplasia and cervical cancer, and the role of microorganisms in chronic prostatitis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: ObservationVaginal microbiota in gestation CPP women without HPV infection |
| GroupB | – | –Vaginal microbiota in gestation women without CPP and HPV infection |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Gestational participants without HPV infection
Key inclusion criteria (1 listed)
- Those are aged 20 to 45 years old, have vaginal intercourse more than 3 years, and aren't in menstrual, pregnancy or puerperium period.
Key exclusion criteria (1 listed)
- Those are aged more than 45 years old without HPV infection in the last one year, having no vaginal intercourse, and those can't cooperate the examiner. Women who are HIV or hepatitis B/C positive, have autoimmune disorders and systemic disease (like diabetes mellitus, hormone treatment diseases, severe liver and kidney dysfunction), or have severe mental illness and malignant tumors are also excluded. At the same time, all the participants should meet the following requirements: no vagina douching within last 2 days, no vaginal intercourse within last 3 days, no systemic application of antifungal agents or antibiotics or pessaries within last 14 days of sampling.
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 |
|---|---|---|
| ObservationThe patients with the negative results of HPV infection, and assigned to different group according to the CPP manifestation. | Other | Group A |
Primary outcome
Vaginal microbiota difference
Time frame: one year
Vaginal microbiota difference between the women with or without CPP, and all the cases are cervical HPV negative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
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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.
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 Pelvic Pain, run by Peking Union Medical College Hospital at 1 site 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 1 inclusion and 1 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 29 Aug 2019. 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 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 Shu Wang (+86-18810535568, chaoxp_pumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal microbiota difference (time frame: one year). 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 29 Aug 2019.