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

Polycystic Ovary Syndrome Clinical Trial

Official title:

Relationship of Metabolic Parameters, Endocrine and Prolactin Levels in Taiwan's Women With Polycystic Ovary Syndrome and Hyperprolactinemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117272
• Other study ID #: WFH-PCOS-98009
• Status: Completed
• Phase: N/A
• First received: May 3, 2010
• Last updated: November 13, 2013
• Start date: May 2009
• Est. completion date: April 2010

Study information

• Verified date: November 2013
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. completion date: April 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperprolactinemia
• Polycystic Ovary Syndrome
• Syndrome

Locations

Country	Name	City	State
Taiwan	Taipei Medical University WanFang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hyperprolactin		Who visited the Reproductive Endocrinology Clinic at Taipei Medical University-Wan Fang Medical Center from April 2004 to June 2007