Regular Menstrual CycleNCT01604603
The Clinical and Biochemical Characteristics in Women With Different Menstrual Pattern
An observational study of Regular Menstrual Cycle and Irregular Menstrual Cycle, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Background: Menstrual disturbance is the major complain in reproductive age women, the clinical and biochemical characteristics of women with different menstrual disturbance had not been well-understood. Read more about this study
- Who is it for?
- Ages 13 to 45 years, women only
- Conditions the study is for
- Regular Menstrual Cycle, Irregular Menstrual Cycle
- How many people
- 470 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2012to Apr 2013
- 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
- No healthy volunteers
- Child, Adult
Study population: Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45.
Who may be able to join
- Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45.
Who cannot join
- Women who experienced menarche <3 years before the beginning of the study;
- Women who received hormones or drugs for major medical diseases;
- Women who presented ovarian cysts or ovarian tumors, uterine abnormality;
- Women who were >45 years old.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
WanFang Medical Center at Taipei Medical University
Taipei, Taiwan, 110
About this study
Background: Menstrual disturbance is the major complain in reproductive age women, the clinical and biochemical characteristics of women with different menstrual disturbance had not been well-understood. Objective: To study the clinical and biochemical characteristics of women with oligomenorrhea, amenorrhea, and premature ovarian failure. Method: Retrospective study, medical records reviewed in patients who visited to outpatient clinic of Reproductive Medicine in Taipei Medical University - Wan Fang Hospital form 2009 Jan. 1 to 2011 Nov. 31. Including criteria: Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45. Excluding criteria: (1) Women who experienced menarche <3 years before the beginning of the study; (2) Women who received hormones or drugs for major medical diseases; (3) Women who presented ovarian cysts or ovarian tumors, uterine abnormality; (4) Women who were >45 years old.
- Conditions
- Regular Menstrual Cycle, Irregular Menstrual Cycle
- Medical subject headings
- Menstruation Disturbances
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 |
|---|---|---|
| Control | Not described | |
| Oligomenorrhea | Not described | |
| Amenorrhea | Not described | |
| premature ovarian failure | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regular Menstrual CycleStudies 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
- Time perspective
- Retrospective
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-I Hsu, Taipei Medical University WanFang Hospital
- Investigators
- Ming I Hsu, MD, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604603
- Sponsor's protocol ID
- WFH-TMU-RetroMcLab-201203022
- Status last verified
- Nov 2013
- First submitted
- 21 May 2012
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Biochemical Characteristics in Women With Different Menstrual Pattern
- ClinicalTrials.gov ID
- NCT01604603
- Acronym / sponsor ID
- WFH-TMU-RetroMcLab-201203022
- Conditions
- Regular Menstrual Cycle, Irregular Menstrual Cycle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 23 May 2012 (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.
Background: Menstrual disturbance is the major complain in reproductive age women, the clinical and biochemical characteristics of women with different menstrual disturbance had not been well-understood. Objective: To study the clinical and biochemical characteristics of women with oligomenorrhea, amenorrhea, and premature ovarian failure. Method: Retrospective study, medical records reviewed in patients who visited to outpatient clinic of Reproductive Medicine in Taipei Medical University - Wan Fang Hospital form 2009 Jan. 1 to 2011 Nov. 31. Including criteria: Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45. Excluding criteria: (1) Women who experienced menarche <3 years before the beginning of the study; (2) Women who received hormones or drugs for major medical diseases; (3) Women who presented ovarian cysts or ovarian tumors, uterine abnormality; (4) Women who were >45 years old.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | – |
| Oligomenorrhea | – | – |
| Amenorrhea | – | – |
| premature ovarian failure | – | – |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45.
Key inclusion criteria (1 listed)
- Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45.
Key exclusion criteria (4 listed)
- Women who experienced menarche <3 years before the beginning of the study;
- Women who received hormones or drugs for major medical diseases;
- Women who presented ovarian cysts or ovarian tumors, uterine abnormality;
- Women who were >45 years old.
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
Not reported in the source record.
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 6 Nov 2013.
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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.
Ming I Hsu, MD principal investigator
Taipei Medical University WanFang Hospital
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 Regular Menstrual Cycle and Irregular Menstrual Cycle, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 4 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 6 Nov 2013. 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 Taiwan. 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.
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 6 Nov 2013.