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The Relationship of PRL and Polycystic Ovary Syndrome (PCOS) in Taiwan's Women

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ClinicalTrials.gov Identifier: NCT01117272
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : November 14, 2013
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, Taipei Medical University WanFang Hospital

Tracking Information
First Submitted Date May 3, 2010
First Posted Date May 5, 2010
Last Update Posted Date November 14, 2013
Study Start Date May 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 10, 2013)
hyperprolactin [ Time Frame: Who visited the Reproductive Endocrinology Clinic at Taipei Medical University-Wan Fang Medical Center from April 2004 to June 2007 ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01117272 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Relationship of PRL and Polycystic Ovary Syndrome (PCOS) in Taiwan's Women
Official Title Relationship of Metabolic Parameters, Endocrine and Prolactin Levels in Taiwan's Women With Polycystic Ovary Syndrome and Hyperprolactinemia.
Brief Summary

Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder of reproductive-age women. According to Rotterdam 2003 criteria: at least two of three criteria are met, hyperandrogenism, chronic anovulation, and polycystic ovary. PCOS will cause irregular menstrual cycle, infertility, acne, hirsutism, obesity, or/and metabolic syndrome, diabetes that may increase risk of cardiovascular disease.

Hyperprolactinaemia is also a common problem in reproductive aged women. Both hyperprolactinaemia and PCOS had endocrine disorder and irregular menstrual cycle. Investigators hope to collect clinical data from PCOS and prolactinemia patients followed in Wang Fang hospital for many years in endocrinological and metabolical aspects for comparison. Investigators at the same time would like to understand more about other similarities and differences between these two endocrinological dysfunction for future study.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Polycystic Ovary syndrome(PCOS)
Condition Polycystic Ovary Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • PCOS group
    Who met the 2003 Rotterdam criteria.
  • Mild hyperprolactinaemia group
    Who were diagnosed with prolactin levels above the upper limit of normal (24.29 ng/ml) and under 100 ng/ml.
  • Control group
    Without PCOS and with normal prolactin levels.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 13, 2013)
474
Original Estimated Enrollment
 (submitted: May 4, 2010)
750
Actual Study Completion Date April 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • PCOM by ultrasound Diagnosis
  • Anovulation, Oligo menses
  • Hyperandrogenism

Exclusion Criteria:

  • Women who had been diagnosed with other etiology that should be excluded in PCOS diagnosis, such as hyperprolactinemia, hypogonadotropic hypogonadism, premature ovarian failure, congenital adrenal hyperplastic, androgen-secreting tumor, Cushing's syndrome, disorders of uterus( such as Asherman's syndrome, Mullerian agenesis), chromosomal anomalies( such as Turner syndrome).
  • Women who did not have sufficient clinical or biochemical records.
  • Girls who had menarche at <3 years of age and women who were >40 years of age.
Sex/Gender
Sexes Eligible for Study: Female
Ages 15 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01117272
Other Study ID Numbers WFH-PCOS-98009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ming-I Hsu, Taipei Medical University WanFang Hospital
Study Sponsor Taipei Medical University WanFang Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Ming-I Hsu, MD Taipei Medical University WanFang Hospital
PRS Account Taipei Medical University WanFang Hospital
Verification Date November 2013