MenorrhagiaNCT02685501
Menorrhagia, Dysmenorrhea and Iron Deficiency Among Young Women Soldiers and Effect on Activity
An observational study of Menorrhagia and Dysmenorrhea, run by Hadassah Medical Organization at 2 sites in Israel.
Trial summary
As combat women soldiers are required to more intensive daily activity the investigators believe that the impact of menorrhagia, dysmenorrhea and its clinical consequence (as characterized by, anemia iron deficiency and reduced quality of life)) on personal performance will be more significant in combat women soldiers… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menorrhagia, Dysmenorrhea, Iron Deficiency Anemia
- How many people
- 800 participants
- Where
- 2 sitesIsrael
- Study dates
- Jan 2016to Jun 2017
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women soldiers
Who may be able to join
- Women soldiers in the participating units
Who cannot join
- Lack of consent
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem, 91120
Shoshana Revel-Vilk, MD MSc, 972-2-6777408, shoshanav@hadassah.org.il
- Recruiting
Hadassah Medical Organization
Jerusalem
Hadas Lemberg, PhD, 0097226777572, lhadas@hadassah.org.il
Shoshana Revel-Vilk, MD
About this study
Official title: Menorrhagia, Dysmenorrhea and Iron Deficiency Among Young Women Soldiers
As combat women soldiers are required to more intensive daily activity the investigators believe that the impact of menorrhagia, dysmenorrhea and its clinical consequence (as characterized by, anemia iron deficiency and reduced quality of life)) on personal performance will be more significant in combat women soldiers compared to non-combat women soldiers. Using cohorts from the same environment will enable the investigators to better study the effect of menorrhagia and dysmenorrhea eliminating other uncontrolled factors, such as nutrition. The study does not include any intervention.
- Conditions
- Menorrhagia, Dysmenorrhea, Iron Deficiency Anemia
- Being tested
- no intervention
- Medical subject headings
- Menorrhagia, Dysmenorrhea, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Combat women soldiers | Women soldiers in combat units Receives: Other: no intervention | |
| Non combat women soldiers | Women soldiers in non-combat units Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menorrhagia and dysmenorrhea
The prevalence of menorrhagia and dysmenorrhea and association with quality of life will be assessed
Measured: one year
Secondary outcomes (1)
Iron deficiency
The prevalence of iron deficiency and iron deficiency anemia will be assessed by laboratory tests.
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 posted18 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenorrhagiaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoshana Vilk, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685501
- Sponsor's protocol ID
- Menorrhagia-HMO-CTIL
- Status last verified
- Feb 2016
- First submitted
- 14 Feb 2016
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menorrhagia, Dysmenorrhea and Iron Deficiency Among Young Women Soldiers
- ClinicalTrials.gov ID
- NCT02685501
- Acronym / sponsor ID
- Menorrhagia-HMO-CTIL
- Conditions
- Menorrhagia, Dysmenorrhea, Iron Deficiency Anemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 18 Feb 2016 (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.
As combat women soldiers are required to more intensive daily activity the investigators believe that the impact of menorrhagia, dysmenorrhea and its clinical consequence (as characterized by, anemia iron deficiency and reduced quality of life)) on personal performance will be more significant in combat women soldiers compared to non-combat women soldiers. Using cohorts from the same environment will enable the investigators to better study the effect of menorrhagia and dysmenorrhea eliminating other uncontrolled factors, such as nutrition. The study does not include any intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combat women soldiers | – | Other: no interventionWomen soldiers in combat units |
| Non combat women soldiers | – | Other: no interventionWomen soldiers in non-combat units |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women soldiers
Key inclusion criteria (1 listed)
- Women soldiers in the participating units
Key exclusion criteria (1 listed)
- Lack of consent
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 |
|---|---|---|
| no intervention | Other | Combat women soldiers, Non combat women soldiers |
Primary outcome
Menorrhagia and dysmenorrhea
Time frame: one year
The prevalence of menorrhagia and dysmenorrhea and association with quality of life will be assessed
1 secondary outcome
Iron deficiency
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- 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.
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 Menorrhagia and Dysmenorrhea, run by Hadassah Medical Organization at 2 sites in Israel.
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 24 Feb 2016. 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 Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menorrhagia and dysmenorrhea (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 24 Feb 2016.