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
  Purpose

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.


Condition
Polycystic Ovary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Relationship of Metabolic Parameters, Endocrine and Prolactin Levels in Taiwan's Women With Polycystic Ovary Syndrome and Hyperprolactinemia.

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 474
Study Start Date: May 2009
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Polycystic Ovary syndrome(PCOS)

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01117272

Locations
Taiwan
Taipei Medical University WanFang Hospital
Taipei, Taiwan, 116
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Ming-I Hsu, MD Taipei Medical University WanFang Hospital
  More Information

No publications provided

Responsible Party: Ming-I Hsu, Attending Doctor, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01117272     History of Changes
Other Study ID Numbers: WFH-PCOS-98009
Study First Received: May 3, 2010
Last Updated: November 13, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
PCOS
hyperprolactinemia
obesity
hyperandrogenic

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Hyperprolactinemia
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014