Dataset Information

Effects of transdermal testosterone on natriuretic peptide levels in women: a randomized placebo-controlled pilot study.

ABSTRACT:

Objective

To investigate whether testosterone administration alters natriuretic peptide levels in women.

Design

Three-month, double-blind, randomized, placebo-controlled study.

Setting

Clinical research center.

Patient(s)

Fifty-one women with hypoandrogenemia due to hypopituitarism.

Intervention(s)

Transdermal testosterone (300 ?g daily) or placebo patch.

Main outcome measure(s)

N-Terminal pro-B-type natriuretic peptide (NT-proBNP) levels.

Result(s)

NT-proBNP levels decreased in the transdermal testosterone group compared with placebo over three months. The difference between groups remained significant after controlling for baseline age, systolic blood pressure, body mass index, and homeostasis model assessment of insulin resistance. Change in NT-proBNP over 3 months was inversely associated with change in free testosterone levels.

Conclusion(s)

Testosterone administration to women results in decreased natriuretic peptide levels, suggesting that testosterone may be an inverse regulator of the natriuretic peptide system.

Clinical trials registration number

NCT00027430.

SUBMITTER: Lin E

PROVIDER: S-EPMC3269509 | biostudies-literature | 2012 Feb

REPOSITORIES: biostudies-literature

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Publications

Effects of transdermal testosterone on natriuretic peptide levels in women: a randomized placebo-controlled pilot study.

Lin Eleanor E McCabe Elizabeth E Newton-Cheh Christopher C Bloch Kenneth K Buys Emmanuel E Wang Thomas T Miller Karen K KK

Fertility and sterility 20111202 2

<h4>Objective</h4>To investigate whether testosterone administration alters natriuretic peptide levels in women.<h4>Design</h4>Three-month, double-blind, randomized, placebo-controlled study.<h4>Setting</h4>Clinical research center.<h4>Patient(s)</h4>Fifty-one women with hypoandrogenemia due to hypopituitarism.<h4>Intervention(s)</h4>Transdermal testosterone (300 μg daily) or placebo patch.<h4>Main outcome measure(s)</h4>N-Terminal pro-B-type natriuretic peptide (NT-proBNP) levels.<h4>Result(s)< ...[more]

PMID: 22137497

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Project description:ObjectiveLow-dose testosterone has been shown to improve depression symptom severity, fatigue, and sexual function in small studies in women not formally diagnosed with major depressive disorder. The authors sought to determine whether adjunctive low-dose transdermal testosterone improves depression symptom severity, fatigue, and sexual function in women with antidepressant-resistant major depression. A functional MRI (fMRI) substudy examined effects on activity in the anterior cingulate cortex (ACC), a brain region important in mood regulation.MethodsThe authors conducted an 8-week randomized double-blind placebo-controlled trial of adjunctive testosterone cream in 101 women, ages 21-70, with antidepressant-resistant major depression. The primary outcome measure was depression symptom severity as assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary endpoints included fatigue, sexual function, and safety measures. The primary outcome of the fMRI substudy (N=20) was change in ACC activity.ResultsThe participants' mean age was 47 years (SD=14) and their mean baseline MADRS score was 26.6 (SD=5.9). Eighty-seven (86%) participants completed 8 weeks of treatment. MADRS scores decreased in both study arms from baseline to week 8 (testosterone arm: from 26.8 [SD=6.3] to 15.3 [SD=9.6]; placebo arm: from 26.3 [SD=5.4] to 14.4 [SD=9.3]), with no significant difference between groups. Improvement in fatigue and sexual function did not differ between groups, nor did side effects. fMRI results showed a relationship between ACC activation and androgen levels before treatment but no difference in ACC activation with testosterone compared with placebo.ConclusionsAdjunctive transdermal testosterone, although well tolerated, was not more effective than placebo in improving symptoms of depression, fatigue, or sexual dysfunction. Imaging in a subset of participants demonstrated that testosterone did not result in greater activation of the ACC.

Dataset Information

Effects of transdermal testosterone on natriuretic peptide levels in women: a randomized placebo-controlled pilot study.

Objective

Design

Setting

Patient(s)

Intervention(s)

Main outcome measure(s)

Result(s)

Conclusion(s)

Clinical trials registration number

Publications

Effects of transdermal testosterone on natriuretic peptide levels in women: a randomized placebo-controlled pilot study.

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