Objective: Women with primary ovarian insufficiency (POI) display low androgen levels, which could contribute to mood and behavioral symptoms observed in this condition. We examined the effects of physiologic testosterone therapy added to standard estrogen/progestin therapy on quality of life, self-esteem, and mood in women with POI.
Methods: One hundred twenty-eight women with 46,XX spontaneous POI participated in a 12-month randomized, placebo-controlled, parallel-design investigation of the efficacy of testosterone augmentation of estrogen/progestin therapy. Quality of life, self-esteem, and mood symptoms were evaluated with standardized rating scales and a structured clinical interview. Differences in outcome measures between the testosterone and placebo treatments were analyzed by Wilcoxon rank sum tests.
Results: No differences in baseline characteristics, including serum hormone levels (P > 0.05), were found. Baseline mean (SD) Center for Epidemiologic Studies Depression Scale scores were 10.7 (8.6) and 9.2 (7.8) for testosterone and placebo, respectively (P = 0.35). After 12 months of treatment, measures of quality of life, self-esteem, and mood symptoms did not differ between treatment groups. Serum testosterone levels achieved physiologic levels in the testosterone group and were significantly higher compared with placebo (P < 0.001). Baseline testosterone levels were not associated with either adverse or beneficial clinical effects.
Conclusions: A 150-μg testosterone patch achieves physiologic hormone levels in women with POI. Our findings suggest that augmentation of standard estrogen/progestin therapy with physiologic testosterone therapy in young women with POI neither aggravates nor improves baseline reports of quality of life or self-esteem and had minimal effects on mood. Other mechanisms might play a role in the altered mood accompanying this disorder.
From the 1Behavioral Endocrinology Branch, National Institute of Mental Health; 2Integrative Reproductive Medicine Group, Intramural Research Program on Reproductive and Adult Endocrinology, National Institute of Child Health and Human Development; 3Biostatistics and Clinical Epidemiology Service, Office of the Deputy Director of Clinical Care, Clinical Center, National Institutes of Health, Department of Health and Human Services, Bethesda, MD; and 4Department of Psychiatry, University of North Carolina, Chapel Hill, NC.
Received September 30, 2013; revised and accepted November 26, 2013.
P.J.S. and L.M.N. contributed equally to this work. This work was written as part of their official duties as government employees.
The views expressed in this article do not necessarily represent the views of the National Institute of Mental Health, National Institutes of Health, Department of Health and Human Services, or US Government.
Preliminary results of this study were presented at the 2013 Society of Biological Psychiatry annual meeting and have not been presented or published elsewhere.
Clinical Trial Registration: NCT00001951 (Hormone Replacement in Young Women with Premature Ovarian Failure; http://www.clinicaltrials.gov/ct2/show/NCT00001951?term=NCT00001951&rank=1).
Funding/support: This work was supported by the Intramural Research Program of the National Institute of Child Health and Human Development, National Institutes of Health, and Procter & Gamble under Cooperative Research and Development Agreement (CRADA 00983).
Financial disclosure/conflicts of interest: D.R.R. is a funded member of the editorial board for a Servier-sponsored journal (Dialogues in Clinical Neuroscience). None of the other authors have any disclosures or conflicts of interest to report.
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