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Presentations of Hyperandrogenic Phenotypes in Taiwanese Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01940666
First received: April 5, 2013
Last updated: November 5, 2013
Last verified: November 2013

April 5, 2013
November 5, 2013
September 2012
March 2013   (final data collection date for primary outcome measure)
Clinical and Biochemical Presentations of Distinctive Types of Biochemical Hyperandrogenism in Premenopausal Taiwanese Women [ Time Frame: A retrospective study in 160 Taiwanese women with HA and 165 women without HA, with medical records reviewed from January 1, 2009, through July 21, 2012 (up to 3.5 years) ] [ Designated as safety issue: No ]
Androgens (Total Testosterone (TT) (nmol/L), androstenedione (A4)(ng/ml), free androgen index (FAI), and dehydroepiandrosterone sulfate (DHEA-S) (µg/dl ); anthroponmetric components (body mass index (BMI)(Kg/m2) , waist (cm), Waist-to-hip ratio (W/H)); average menstrual interval, antimullerian hormone(AMH)(ng/ml) adiponectin (ng/nl), leptin(ng/ml), adiponectin/leptin (A/L) ratio, and insulin resistance markers( fasting insulin (µIU/ml), glucose-to-insulin ratio (GIR), Homeostasis model assessment insulin resistance (HOMA-IR) Index, Lipid Accumulation Product Index (LAP Index)).
Same as current
Complete list of historical versions of study NCT01940666 on ClinicalTrials.gov Archive Site
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Presentations of Hyperandrogenic Phenotypes in Taiwanese Women
Clinical and Biochemical Presentations of Distinctive Types of Biochemical Hyperandrogenism in Premenopausal Taiwanese Women

STUDY QUESTION: Which of the four abnormally elevated androgen groups (total testosterone [TT], androstenedione [A4], free androgen index [FAI], or dehydroepiandrosterone-sulfate [DHEA-S]) present with an unfavorable metabolic and hormonal profile, appear to be more insulin-resistant and pose additional cardiovascular risk? SUMMARY ANSWER: Subjects with excess free androgen index tend to be obese and face the highest metabolic syndrome risk, adipocytokine alterations, insulin resistance (IR) and cardiovascular risk. The excess TT group presents with a marginal IR risk, while the excess A4 group has the highest antimüllerian hormone (AMH), and may counterbalance obesity; this group and the excess DHEA-S group have a favorable association with IR.

STUDY DESIGN, SIZE, DURATION:A retrospective study in 160 Taiwanese women with HA and 165 women without HA, with medical records reviewed from 2009 up to 2012. The hyperandrogenic women were classified into four groups (TT, A4, FAI, and DHEA-S) according to independent abnormally elevated androgen measures each above its cut-off value, and the groups were compared with each other and with controls.

PARTICIPANTS/MATERIALS, SETTING, METHODS: This study was performed in the Reproductive Endocrinology Clinic at Wan Fang Medical Center in Taipei, Taiwan. Anthropometric, metabolic, endocrine, and IR components as well as lipid accumulation product (LAP) index were compared between the groups. IR was assessed with the following markers: fasting glucose and insulin levels, oral glucose tolerance test, glucose-to-insulin ratio and homeostasis model assessment of IR index (HOMA-IR).

Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Probability Sample

A retrospective review of the medical records of women who visited the Reproductive Endocrinology Clinic was carried out at the Wan Fang Medical Center at Taipei Medical University from 2009 and up to 2012. A total of 160 Taiwanese women with hyperandrogenism (HA) and 165 women without hyperandrogenism (non-HA) were included in the study.

  • Hyperandrogenism,
  • Polycystic Ovary Syndrome,
  • Metabolic Syndrome,
  • Insulin Resistance,
  • Cardiovascular Disease.
Not Provided
  • Controls
    patients who have all androgens (TT, A4, FAI, and DHEA-S) lower than their cut-off values
  • Total Testosterone >= 2.39
    Patients who have only total testosterone higher than its cut-off value; (TT) >=2.39
  • Androstenedione >= 2.99
    Patients who have only androstenedione higher than its cut-off value; (A4) >=2.99
  • Free Androgen Index >= 6.53
    Patients who have only free androgen index higher than its cut-off value; (FAI) >=6.53
  • DHEAs >= 181.55
    Patients who have only dehyroepiandrosterone sulfate higher than its cut-off value; (DHEA-S)>=181.55
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
649
July 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hyperandrogenic women who were classified into four groups:

    • Total testosterone (TT),
    • Androstenedione (A4),
    • Free androgen index (FAI),
    • and Dehydroepiandrosterone sulphate(DHEA-S).
  • According to abnormally elevated androgen measures each above its cut-off value, and non hyperandrogenic women (who had all androgens below their cut-off values)

Exclusion Criteria:

  • None of the women studied had

    • Hypogonadotropic hypogondism,
    • Hyperprolactinemia,
    • Congenital adrenal hyperplasia,
    • Premature ovarian failure,
    • Androgen-secreting tumors,
    • Cushing's syndrome,
    • or any other endocrine or systemic disease that may affect the reproductive function,
    • or any disorders of the uterus (e.g. Asherman's syndrome and Mullerian genesis) and chromosomal anomalies (e.g. Turner's syndrome).
  • In addition, we excluded females who had

    • Experienced menarche less than three years preceding the study start,
    • or who had day 3 FSH > 15 mIU/ml, as well as women with insufficient clinical/biochemical records,
    • and women with ovarian cysts or tumors in an ultrasonographic examination.
Female
13 Years to 48 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01940666
WFH-TMU-PCOS-201207025
No
Ming-I Hsu, Taipei Medical University WanFang Hospital
Taipei Medical University WanFang Hospital
Not Provided
Principal Investigator: Ming I Hsu, MD WanFang Medical Center at Taipei Medical University
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