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Total testosterone assays in women with polycystic ovary syndrome: precision and correlation with hirsutism.

ABSTRACT: There is no standardized assay of testosterone in women. Liquid chromatography mass spectrometry (LC/MS) has been proposed as the preferable assay by an Endocrine Society Position Statement.The aim was to compare assay results from a direct RIA with two LC/MS.We conducted a blinded laboratory study including masked duplicate samples at three laboratories--two academic (University of Virginia, RIA; and Mayo Clinic, LC/MS) and one commercial (Quest, LC/MS).Baseline testosterone levels from 596 women with PCOS who participated in a large, multicenter, randomized controlled infertility trial performed at academic health centers in the United States were run by varying assays, and results were compared.We measured assay precision and correlation and baseline Ferriman-Gallwey hirsutism scores.Median testosterone levels were highest with RIA. The correlations between the blinded samples that were run in duplicate were comparable. The correlation coefficient (CC) between LC/MS at Quest and Mayo was 0.83 [95% confidence interval (CI), 0.80-0.85], between RIA and LC/MS at Mayo was 0.79 (95% CI, 0.76-0.82), and between RIA and LC/MS at Quest was 0.67 (95% CI, 0.63-0.72). Interassay variation was highest at the lower levels of total testosterone (?50 ng/dl). The CC for Quest LC/MS was significantly different from those derived from the other assays. We found similar correlations between total testosterone levels and hirsutism score with the RIA (CC=0.24), LC/MS at Mayo (CC=0.15), or Quest (CC=0.17).A testosterone RIA is comparable to LC/MS assays. There is significant variability between LC/MS assays and poor precision with all assays at low testosterone levels.

SUBMITTER: Legro RS

PROVIDER: S-EPMC2999971 | biostudies-literature | 2010 Dec

REPOSITORIES: biostudies-literature

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Total testosterone assays in women with polycystic ovary syndrome: precision and correlation with hirsutism.

Legro Richard S RS Schlaff William D WD Diamond Michael P MP Coutifaris Christos C Casson Peter R PR Brzyski Robert G RG Christman Gregory M GM Trussell J C JC Krawetz Stephen A SA Snyder Peter J PJ Ohl Dana D Carson Sandra A SA Steinkampf Michael P MP Carr Bruce R BR McGovern Peter G PG Cataldo Nicholas A NA Gosman Gabriella G GG Nestler John E JE Myers Evan R ER Santoro Nanette N Eisenberg Esther E Zhang Meizhuo M Zhang Heping H

The Journal of clinical endocrinology and metabolism 20100908 12

<h4>Context</h4>There is no standardized assay of testosterone in women. Liquid chromatography mass spectrometry (LC/MS) has been proposed as the preferable assay by an Endocrine Society Position Statement.<h4>Objective</h4>The aim was to compare assay results from a direct RIA with two LC/MS.<h4>Design and setting</h4>We conducted a blinded laboratory study including masked duplicate samples at three laboratories--two academic (University of Virginia, RIA; and Mayo Clinic, LC/MS) and one commer ...[more]

PMID: 20826578

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Project description:ContextOvarian and adrenal steroidogenesis underlie endocrine-metabolic dysfunction in polycystic ovary syndrome (PCOS). Adipocytes express aldo-keto reductase 1C3 and type 1 11β-hydroxysteroid dehydrogenase, which modulate peripheral androgen and cortisol production.ObjectivesTo compare serum adrenal steroids, including 11-oxygenated androgens (11-oxyandrogens), cortisol, and cortisone between normal-weight women with PCOS and body mass index- and age-matched ovulatory women with normal-androgenic profiles (controls), and assess whether adrenal steroids associate with abdominal adipose deposition.DesignProspective, cross-sectional, cohort study.SettingAcademic medical center.PatientsTwenty normal-weight women with PCOS and 20 body mass index-/age-matched controls.InterventionsBlood sampling, IV glucose tolerance testing, and total-body dual-energy x-ray absorptiometry.Main outcome measuresClinical characteristics, hormonal concentrations, and body fat distribution.ResultsWomen with PCOS had higher serum total/free testosterone (T) and androstenedione (A4) levels and a greater android/gynoid fat mass than controls (androgens P < .001; android/gynoid fat mass ratio, P = .026). Serum total/free T and A4 levels correlated positively with android/gynoid fat mass ratio in all women combined (P < .025, all values). Serum 11ß-hydroxyA4, 11-ketoA4, 11ß-hydroxyT, 11-ketoT, cortisol, and cortisone levels were comparable between female types and unrelated to body fat distribution. Serum 11-oxyandrogens correlated negatively with % total body fat, but lost significance adjusting for cortisol. Serum cortisol levels, however, correlated inversely with android fat mass (P = .021), with a trend toward reduced serum cortisol to cortisone ratio in women with PCOS vs controls (P = .075), suggesting diminished 11β-hydroxysteroid dehydrogenase activity.ConclusionReduced cortisol may protect against preferential abdominal fat mass in normal-weight PCOS women with normal serum 11-oxyandrogens.

Project description:BACKGROUND:Polycystic ovary syndrome (PCOS) affects 5%-15% of women and is the most common cause of hirsutism. Data on the time-course of improvement to suppressive therapy and predictors of that response in PCOS are lacking. The objectives of our study are to determine the long-term response and identify predictors of response in PCOS women treated with suppressive therapy, including spironolactone (SPL) + oral contraceptives (OCs). MATERIALS AND METHODS:Retrospective cross-sectional analysis of 200 women with PCOS (1990 NIH criteria) treated with suppressive therapy in general, and a subgroup of 138 subjects treated with OCP+SPL who had been prospectively included in a biorepository. Main outcome measure included improvement rate per 100 person-month of follow-up for hirsutism, menstrual irregularity and acne measured qualitatively as "feeling better", and changes in the severity of hirsutism quantified by modified Ferriman-Gallwey [mF-G] score. RESULTS:During a mean follow-up of 34.2 months, 85.1%, 82.7%, and 79.3% of patients reported improvement in hirsutism, menstrual dysfunction, and acne, respectively. The modified Ferriman-Gallwey (mF-G) hirsutism score improved by 59.9%. The net reduction in mF-G score and the percent of patients reporting improvement in hirsutism were greater for OC+SPL than for either drug alone, with no difference in the percent of patients free of adverse effects. Among those treated with OC+SPL (n?=?138), the initial mF-G and sex hormone-binding globulin (SHBG) independently predicted successful therapy for hirsutism. CONCLUSION:There is a high rate of patient satisfaction with suppressive therapy in PCOS. The efficacy of suppressive therapy for hirsutism was greater with OC+SPL than with either drug alone. Successful treatment of hirsutism with combination OC+SPL requires at least 6 months of therapy, with the proportion of satisfied patients continuing to increase with treatment duration. The probability of patient satisfaction with OC+SPL treatment for hirsutism can be predicted by her initial mF-G score or SHBG level.

Dataset Information

Total testosterone assays in women with polycystic ovary syndrome: precision and correlation with hirsutism.

Publications

Total testosterone assays in women with polycystic ovary syndrome: precision and correlation with hirsutism.

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