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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01117272
First received: May 3, 2010
Last updated: November 13, 2013
Last verified: November 2013

May 3, 2010
November 13, 2013
May 2009
February 2010   (final data collection date for primary outcome measure)
hyperprolactin [ Time Frame: Who visited the Reproductive Endocrinology Clinic at Taipei Medical University-Wan Fang Medical Center from April 2004 to June 2007 ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01117272 on ClinicalTrials.gov Archive Site
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The Relationship of PRL and Polycystic Ovary Syndrome (PCOS) in Taiwan's Women
Relationship of Metabolic Parameters, Endocrine and Prolactin Levels in Taiwan's Women With Polycystic Ovary Syndrome and Hyperprolactinemia.

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.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample

Polycystic Ovary syndrome(PCOS)

Polycystic Ovary Syndrome
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  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
474
April 2010
February 2010   (final data collection date for primary outcome measure)

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.
Female
15 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01117272
WFH-PCOS-98009
No
Ming-I Hsu, Taipei Medical University WanFang Hospital
Taipei Medical University WanFang Hospital
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Principal Investigator: Ming-I Hsu, MD Taipei Medical University WanFang Hospital
Taipei Medical University WanFang Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP