Condylomata AcuminataNCT01483794
Epidemiology, Costs and Psychosocial Consequences of Genital Warts in Valparaiso, Chile
An observational study of Condylomata Acuminata, run by Universidad de Valparaiso at 2 sites in Chile.
Trial summary
This is an observational study looking at the characteristics of patients consulting for genital warts in the first semester 2010 at the public sexual health clinic of Valparaiso, Chile. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Condylomata Acuminata
- How many people
- 60 participants
- Where
- 2 sitesChile
- Study dates
- Nov 2011to Apr 2012
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending the public sexual health clinic of Valparaiso, Chile
Who may be able to join
- Men and women 18 years of age or older
- Having being diagnosed with genital warts
- Consulting the sexual health clinic only for genital warts
- Patients accepting to be included in the study
Who cannot join
- Immunodeficiency
- HIV positive
- Having being diagnosed with cancer or pre-cancerous lesions
- Pregnancy
- Presenting a sexual transmissible infection other than genital warts.
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Sexual Health Clinic,
Valparaíso, Valparaiso, V
Carolina San Martin, MD, +56-9-92895478, caroladc@hotmail.com
Heraldo S Povea, MD, +56-9-91629388, heraldopoveapacci@gmail.com
Sexual Health Clinic
Valparaíso, Valparaiso, V
Carolina San Martin, MD
About this study
Official title: Genital Warts: Studies for Establishing Epidemiological Profile, Psychosocial Consequences and Costs of Disease in Attendants to the Sexual Health Clinic of the Public Health Service of Valparaiso and San Antonio, Chile.
This is an observational study looking at the characteristics of patients consulting for genital warts in the first semester 2010 at the public sexual health clinic of Valparaiso, Chile. The objectives are: to have an epidemiological profile, estimating cost of the disease for the health system and the patient and analyzing possible psychosocial consequences of the condition for the patients.
- Conditions
- Condylomata Acuminata
- Keywords
- genital warts
- Medical subject headings
- Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Genital warts treated | Patients that have had treatment on their genital warts | |
| Genital warts on treatment | Patients currently being treated for genital warts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with altered psychosocial tests as a Measure of impact of presenting genital warts.
The psychosocial consequences of presenting genital warts will be assessed.
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 posted1 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condylomata AcuminataStudies 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
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina San Martin, Universidad de Valparaiso
- Investigators
- Carolina San Martin, MD, Principal investigator, University of Valparaiso, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483794
- Sponsor's protocol ID
- CondValpo2011
- Other IDs
- 1501
- Status last verified
- Nov 2011
- First submitted
- 23 Nov 2011
- Last updated
- 1 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genital Warts: Studies for Establishing Epidemiological Profile, Psychosocial Consequences and Costs of Disease in Attendants to the Sexual Health Clinic of the Public Health Service of Valparaiso and San Antonio, Chile.
- ClinicalTrials.gov ID
- NCT01483794
- Acronym / sponsor ID
- CondValpo2011
- Conditions
- Condylomata Acuminata
- Keywords
- genital warts
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 1 Dec 2011 (estimated)
- 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.
This is an observational study looking at the characteristics of patients consulting for genital warts in the first semester 2010 at the public sexual health clinic of Valparaiso, Chile. The objectives are: to have an epidemiological profile, estimating cost of the disease for the health system and the patient and analyzing possible psychosocial consequences of the condition for the patients.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genital warts treated | – | –Patients that have had treatment on their genital warts |
| Genital warts on treatment | – | –Patients currently being treated for genital warts |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending the public sexual health clinic of Valparaiso, Chile
Key inclusion criteria (4 listed)
- Men and women 18 years of age or older
- Having being diagnosed with genital warts
- Consulting the sexual health clinic only for genital warts
- Patients accepting to be included in the study
Key exclusion criteria (5 listed)
- Immunodeficiency
- HIV positive
- Having being diagnosed with cancer or pre-cancerous lesions
- Pregnancy
- Presenting a sexual transmissible infection other than genital warts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with altered psychosocial tests as a Measure of impact of presenting genital warts.
Time frame: one year
The psychosocial consequences of presenting genital warts will be assessed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2011.
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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.
Carolina San Martin, MD principal investigator
University of Valparaiso, Chile
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 Condylomata Acuminata, run by Universidad de Valparaiso at 2 sites in Chile.
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 4 inclusion and 5 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 1 Dec 2011. 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 Chile. 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 Heraldo S Povea, MD (+56-9-91629388, heraldopoveapacci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with altered psychosocial tests as a Measure of impact of presenting genital warts. (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 1 Dec 2011.