DysmenorrheaNCT00590811
Prevalence of Menstrual Cycle Related Pain Complains in Adolescents and Young Adults
An observational study of Dysmenorrhea and Pelvic Pain, run by University Hospital, Gasthuisberg at 2 sites in Belgium.
Trial summary
The aim of this study is to determine the prevalence of menstrual cycle related pain complains in adolescents and young adults. Read more about this study
- Who is it for?
- Ages 12 to 25 years, women only
- Conditions the study is for
- Dysmenorrhea, Pelvic Pain
- How many people
- 200 participants
- Where
- 2 sitesBelgium
- Study dates
- Jan 2008to Feb 2010
- 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 12 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: 3rd year high school girls and 1st year university young females having a routine visit to the school doctor or student doctor.
Who may be able to join
- 3rd year high school girls
- 1st year university young females
Who cannot join
- pre-menarcheal girls
Trial locations and contacts
2 sites in 1 country.
About this study
The aim of this study is to determine the prevalence of menstrual cycle related pain complains in adolescents and young adults.
Read the detailed description
An internet questionnaire with 12 items was used:
Adolescents
- start of menstruation
- characteristics of menstrual cycle
- pain related to menstrual cycle (questions based on well-known pain-complaints related to the presence of endometriosis)
- analgetics
- influence on school carrier
- influence on social life
Young adults
- idem as for adolescents
- influence of pain on an eventual sexual relationship
- Conditions
- Dysmenorrhea, Pelvic Pain
- Keywords
- adolescents, young adults, dysmenorrhea, pelvic pain
- Medical subject headings
- Dysmenorrhea, Pelvic Pain
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 |
|---|---|---|
| adolescents | 3rd year high school girls (14-16 years old) | |
| young adults | 1st year university young females (18 - 20 years old) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of menstrual cycle related pain complains
Measured: 3rd year high school & first year university
Secondary outcomes (1)
Relationship between level of pain complains and characteristics of menstrual cycle
Measured: 3rd year high school & first year university
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies 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
- Observational model
- Cohort
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Investigators
- Christel LC Meuleman, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590811
- Sponsor's protocol ID
- EC - 14/11/2007
- Status last verified
- Jan 2010
- First submitted
- 31 Dec 2007
- Last updated
- 1 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Menstrual Cycle Related Pain Complains in Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT00590811
- Acronym / sponsor ID
- EC - 14/11/2007
- Conditions
- Dysmenorrhea, Pelvic Pain
- Keywords
- adolescents, young adults, dysmenorrhea, pelvic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Jan 2008 (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.
The aim of this study is to determine the prevalence of menstrual cycle related pain complains in adolescents and young adults.
Detailed description
An internet questionnaire with 12 items was used:
Adolescents
- start of menstruation
- characteristics of menstrual cycle
- pain related to menstrual cycle (questions based on well-known pain-complaints related to the presence of endometriosis)
- analgetics
- influence on school carrier
- influence on social life
Young adults
- idem as for adolescents
- influence of pain on an eventual sexual relationship
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adolescents | – | –3rd year high school girls (14-16 years old) |
| young adults | – | –1st year university young females (18 - 20 years old) |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 3rd year high school girls and 1st year university young females having a routine visit to the school doctor or student doctor.
Key inclusion criteria (2 listed)
- 3rd year high school girls
- 1st year university young females
Key exclusion criteria (1 listed)
- pre-menarcheal girls
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
Prevalence of menstrual cycle related pain complains
Time frame: 3rd year high school & first year university
1 secondary outcome
Relationship between level of pain complains and characteristics of menstrual cycle
Time frame: 3rd year high school & first year university
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2010.
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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.
Christel LC Meuleman, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
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 Dysmenorrhea and Pelvic Pain, run by University Hospital, Gasthuisberg at 2 sites in Belgium.
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 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: finished, as of the sponsor's last update on 1 Sep 2010. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of menstrual cycle related pain complains (time frame: 3rd year high school & first year university). 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 Sep 2010.