Effects of physiologic testosterone therapy on quality of life, self-esteem, and mood in women with primary ovarian insufficiency

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00001951.

Conflict of interest statement

Conflicts of Interest/Financial Disclosure: None of the other Authors have any disclosures or conflicts of interest to report.

Figures

Figure 1. Study population enrollment and outcomes

An initial sample of 395 women with POI was admitted to the NIH Clinical Center and participated in the screening portion of the longer term study evaluating the effects on bone health between July 2000 and February 2005. Eligibility was reported as the number of women enrolled in the larger 3-year trial. Of these, 267 met exclusion criteria and 145 met inclusion criteria and were enrolled in the larger study, of the 145 women randomized to T or placebo treatment; 17 declined participation in the mood component of the study. Thus, 128 women with POI who were randomized to either T or placebo treatment were enrolled in our study with 123 women completing the study. *Of the six women who had incomplete ratings at the 12-month visit, two in the placebo arm and one in the T treatment arm had incomplete behavior ratings (i.e., CES-D or HAM-D or SCID); the other three women, present in the T treatment arm, completed the Q-Les-Q and one of those also completed the SCID). Therefore, the completed data obtained from these women was included in the analysis.