Comparative Study of Dehydroepiandrosterone versus Femarelle® on Menopausal Systemic and Genitourinary Syndrome

OBJECTIVES: The aim was to evaluate the therapeutic effects of dehydroepiandrosterone (DHEA) and DT56a (Femarelle®) on systemic and genitourinary symptoms of menopause in postmenopausal women. DESIGN: A comparative effectiveness research study of seventy postmenopausal women (mean age: 53 years), experiencing postmenopausal symptoms, was designed. PARTICIPANTS: Seventy patients were randomly assigned to receive either DHEA (60 mg/day) or Femarelle® (644 mg/day) for 3 months. MATERIALS, SETTING, METHODS: Subjects were assessed for serum estradiol, luteinizing hormone, follicle-stimulating hormone, Greene Climacteric Scales Scores, female urinary symptoms, and female sexual function index (FSFI). RESULTS: Both DHEA and Femarelle® demonstrated comparable efficacy in reducing total Greene Climacteric Scale scores. No significant differences in serum follicle-stimulating hormone and E2 levels were observed between the 2 groups. Within-group analyses showed that DHEA was associated with significant improvements in urinary symptoms (overactive bladder symptom score, urinary distress inventory-6, incontinence impact questionnaire-7, international consultation of incontinence questionnaire, and pelvic organ prolapse distress inventory) and sexual function measures (FSFI domains including desire, arousal, lubrication, orgasm, and satisfaction), whereas Femarelle® did not show significant changes over the 3-month period. Between-group comparisons of change scores suggested a trend toward greater improvement in the DHEA group; however, these findings should be interpreted with caution, given the exploratory design and limited sample size. LIMITATIONS: The absence of testosterone measurements limits the assessment of the androgenic effects of DHEA. Femarelle® has never been studied for sexual function; our findings are preliminary and require long-term validation. CONCLUSIONS: While both DHEA and Femarelle® were effective in improving climacteric symptoms, DHEA was associated with improvements in genitourinary symptoms in this cohort. However, given the exploratory design and absence of a placebo control, these findings should be interpreted as hypothesis-generating.