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Comparison of salivary versus serum testosterone levels in postmenopausal women receiving transdermal testosterone supplementation versus placebo

Flyckt, Rebecca L. MD1; Liu, James MD1; Frasure, Heidi MA1; Wekselman, Kathryn PhD, RN2; Buch, Akshay PhD2; Kingsberg, Sheryl A. PhD1

doi: 10.1097/gme.0b013e318199d5c4
Articles

Objective: Clinical assessment of androgen action and its correlation to testosterone levels in women has been challenging. The current gold standard for measuring biologically active testosterone (T) is serum free T by equilibrium dialysis. Alternative methods are desirable due to the cost, complexity, and limited availability of the equilibrium dialysis method. Salivary testing has been proposed as a possible substitute for serum testing. This study compared salivary versus serum measurements of total T (TT), bioavailable T (BT; consisting of free T [FT] and albumin-bound T), and FT from samples collected simultaneously in women who were either receiving transdermal T patch supplementation (300 μg/d) or a placebo patch.

Methods: Naturally and surgically postmenopausal women receiving concomitant hormone therapy were recruited to participate in a 24- to 52-week phase III trial of a 300 μg/day transdermal T patch for the treatment of hypoactive sexual desire disorder.

Results: Initial analysis demonstrated high correlations between TT, BT, and FT levels (r = 0.776-0.855). However, there was no correlation with salivary T levels for any of the serum T subtypes (r = 0.170-0.261). After log transformation, salivary T correlated modestly with BT (r = 0.436, P < 0.001), FT (r = 0.452, P < 0.001), and TT (r = 0.438, P < 0.001).

Conclusions: Although salivary testing of T concentrations is an appealing alternative because it is inexpensive and noninvasive, our results do not support the routine use of salivary T levels in postmenopausal women.

In postmenopausal women, serum concentrations of free, total, and bioavailable testosterone did not demonstrate a strong correlation with salivary testosterone concentrations. These results do not support the routine use of measuring salivary testosterone in postmenopausal women receiving testosterone supplementation.

From the 1Department of Obstetrics and Gynecology, University Hospitals Case Medical Center MacDonald Women's Hospital, Case Western Reserve University School of Medicine, Cleveland, OH; and 2Procter and Gamble Pharmaceuticals, Cincinnati, OH.

Received October 7, 2008; revised and accepted December 22, 2008.

Financial disclosure/conflicts of interest: Drs. Kingsberg and Liu are investigators for Procter & Gamble's testosterone patch. Dr. Wekselman is a former employee of Procter & Gamble. Dr. Bush is an employee of Procter & Gamble.

Address correspondence to: Sheryl Kingsberg, PhD, Departments of Obstetrics and Gynecology and Reproductive Biology, Case Medical Center MacDonald Women's Hospital, Case Western Reserve University School of Medicine, 11100 Euclid Avenue, Mailstop 5034, Cleveland, OH 44106. E-mail: Sheryl.Kingsberg@uhhospitals.org

©2009The North American Menopause Society