Dataset Information

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

ABSTRACT:

Context

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.

Objective

The aim was to compare assay results from a direct RIA with two LC/MS.

Design and setting

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).

Participants and interventions

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.

Main outcome measure

We measured assay precision and correlation and baseline Ferriman-Gallwey hirsutism scores.

Results

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).

Conclusions

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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Publications

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.

Context

Objective

Design and setting

Participants and interventions

Main outcome measure

Results

Conclusions

Publications

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

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