Effects of physiologic testosterone therapy on quality of life, self-esteem, and mood in women with primary ovarian insufficiency.
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.
Gioia M
GM
Guerrieri
Pedro E
PE
Martinez
Summer P
SP
Klug
Nazli A
NA
Haq
Vien H
VH
Vanderhoof
Deloris E
DE
Koziol
Vaishali B
VB
Popat
Sophia N
SN
Kalantaridou
Karim A
KA
Calis
David R
DR
Rubinow
Peter J
PJ
Schmidt
Lawrence M
LM
Nelson
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D020249:Hormone Replacement Therapy; D006801:Humans; D008593:Menopause; D019964:Mood Disorders; D016649:Primary Ovarian Insufficiency / Q000097:blood* / Q000523:psychology; D011594:Psychometrics; D011788:Quality of Life; D012649:Self Concept; D013739:Testosterone / Q000008:administration & dosage* / Q000097:blood; D016896:Treatment Outcome
D013739:Testosterone