NCT01604603

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

November 6, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

May 21, 2012

Last Update Submit

November 4, 2013

Conditions

Study Arms (4)

Control

Oligomenorrhea

Amenorrhea

premature ovarian failure

Eligibility Criteria

Age13 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45.

You may qualify if:

  • Patients had sufficient medical records (anthropometric, endocrine, metabolic, lipid parameters) and age less than 45.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WanFang Medical Center at Taipei Medical University

Taipei, Taiwan, 110, Taiwan

Location

MeSH Terms

Conditions

Menstruation Disturbances

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ming I Hsu, MD

    Taipei Medical University WanFang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Taipei Medical University WanFang Hospital

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 23, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

November 6, 2013

Record last verified: 2013-11

Locations