Menstruation DisturbancesNCT01183377
Frequency of Female Athlete Triad Among Elite Female Athlete of Iran in Different Sport in 2007
An observational study of Menstruation Disturbances and Eating Disorder, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Women's evermore presence in professional and athletic sports has revealed sound evidence on the existence of female athlete triad among the world's elite female athletes. This triad consists of eating disorders, amenorrhea and osteoporosis. Read more about this study
- Who is it for?
- Ages 13 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstruation Disturbances, Eating Disorder, Bone Loss
- How many people
- 250 participants
- Where
- 1 siteIran
- Study dates
- Oct 2006to Mar 2009
- 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 13 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Study population: Professional Iranian female athletes who are members in national teams or federations sports and champion team in Tehran
Who may be able to join
- All Elite Female athletes who play in international teams in sport federation or champion Team in Tehran between 13-45 years old.
Who cannot join
- The 13-15 year old female athletes who are not manarch with secondary sex charactristics.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Rheumatology Research Center, Shariati Hospital
Tehran, Tehran Province, 14114
About this study
Official title: Screening of Menstrual Disorder in Elite Feamle Athlete in Iran
Women's evermore presence in professional and athletic sports has revealed sound evidence on the existence of female athlete triad among the world's elite female athletes. This triad consists of eating disorders, amenorrhea and osteoporosis. It has been stated that all female athletes are potentially at risk, but it is not clear to what extent those exercising at different levels are at risk of this syndrome/triad. Since the manifestation of this triad is often denied, or under-reported, appropriate screening methods are required to identify the symptoms. There is still no clear-cut information available on the incidence of this triad in Iran. And there are religious and cultural differences between Iran's elite female athletes and those in other countries. Therefore, in order to meet Iranian female athletes' needs, the investigators decided to determine the frequency of the female athlete triad in Iran.
- Conditions
- Menstruation Disturbances, Eating Disorder, Bone Loss
- Keywords
- Female Athlete Triad syndrom, Eating disorder, osteoprosis
- Medical subject headings
- Menstruation Disturbances, Feeding and Eating Disorders, Bone Diseases, Metabolic
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 |
|---|---|---|
| 1 | Female athlete Triad syndrom was based on menstrual disorder,Eating Disorder and bone loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Female Athlete Triad among Elite female athlete in Iran in 2006
Measured: 24 month
Secondary outcomes (1)
prevalence of menstrual disorder in female athlete in Iran in 2006
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startOct 2006
- Primary completionFeb 2009
- Study completionMar 2009 (estimated)
Why it stopped: the study terminated last week
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstruation DisturbancesStudies 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
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Haleh Dadgostar, MD, Study director, Rheumatology Research Center, Tehran University for Medical SciencesFereydoun Davatchi, MD, Principal investigator, Rheumatology Research Center, Tehran University for Medical SciencesShafie Movaseghi, MD, Principal investigator, Rheumatology Research Center, Tehran University for Medical Sciencesashraf Aleyasin, MD, Principal investigator, Tehran University for Medical Sciencesmohamad hosein Forozanfar, MD, Principal investigator, Rheumatology Research Center, Tehran University for Medical SciencesTalia Alenabi, MD, Principal investigator, Sport Medicine Federation of Islamic Republic Of IranNarges Chime, MD, Principal investigator, Shahid Beheshti University of Medical Sciencespooneh Kimia ghalam, MD, Principal investigator, Health ministry of Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183377
- Sponsor's protocol ID
- 85-01-41-3488
- Status last verified
- Aug 2010
- First submitted
- 13 Aug 2010
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Menstrual Disorder in Elite Feamle Athlete in Iran
- ClinicalTrials.gov ID
- NCT01183377
- Acronym / sponsor ID
- 85-01-41-3488
- Conditions
- Menstruation Disturbances, Eating Disorder, Bone Loss
- Keywords
- Female Athlete Triad syndrom, Eating disorder, osteoprosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: the study terminated last week
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (estimated)
- First posted
- 17 Aug 2010 (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.
Women's evermore presence in professional and athletic sports has revealed sound evidence on the existence of female athlete triad among the world's elite female athletes. This triad consists of eating disorders, amenorrhea and osteoporosis. It has been stated that all female athletes are potentially at risk, but it is not clear to what extent those exercising at different levels are at risk of this syndrome/triad. Since the manifestation of this triad is often denied, or under-reported, appropriate screening methods are required to identify the symptoms. There is still no clear-cut information available on the incidence of this triad in Iran. And there are religious and cultural differences between Iran's elite female athletes and those in other countries. Therefore, in order to meet Iranian female athletes' needs, the investigators decided to determine the frequency of the female athlete triad in Iran.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Female athlete Triad syndrom was based on menstrual disorder,Eating Disorder and bone loss |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study population: Professional Iranian female athletes who are members in national teams or federations sports and champion team in Tehran
Key inclusion criteria (1 listed)
- All Elite Female athletes who play in international teams in sport federation or champion Team in Tehran between 13-45 years old.
Key exclusion criteria (1 listed)
- The 13-15 year old female athletes who are not manarch with secondary sex charactristics.
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 Female Athlete Triad among Elite female athlete in Iran in 2006
Time frame: 24 month
1 secondary outcome
prevalence of menstrual disorder in female athlete in Iran in 2006
Time frame: 24 month
Results and safety
The study was stopped early (reason given: the study terminated last week). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 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.
Haleh Dadgostar, MD study director
Rheumatology Research Center, Tehran University for Medical Sciences
Fereydoun Davatchi, MD principal investigator
Rheumatology Research Center, Tehran University for Medical Sciences
Shafie Movaseghi, MD principal investigator
Rheumatology Research Center, Tehran University for Medical Sciences
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 Menstruation Disturbances and Eating Disorder, run by Tehran University of Medical Sciences at 1 site in Iran.
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: stopped early, as of the sponsor's last update on 17 Aug 2010. 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 Iran. 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 was stopped early (reason given: the study terminated last week). Results are not available in the source record.
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 Female Athlete Triad among Elite female athlete in Iran in 2006 (time frame: 24 month). 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 17 Aug 2010.