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Electronic letters published:
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Susan R Davis, MBBS FRACP PhD Monash University, Mary-Anne Papalia, Robert J. Norman, Sheila O'Neill, Margaret Redelman, Margaret Williamson, Bronwyn G.A. Stuckey, John Wlodarczyk, Karen Gard'ner, and Andrew Humberstone
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susan.davis{at}med.monash.edu.au Susan R Davis, et al.
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We wish to address readers’ comments regarding our paper reporting the effects of transdermal testosterone for premenopausal women 1. As described in the on line appendix, the discrepancy between screening testosterone at baseline and the data presented, is due to the former being measured by a free testosterone kit assay to achieve quick turn- around at the time of recruitment and the latter being measured using a validated sensitive assay at Esoterix Inc., Calabasas Hills, California, USA. The primary reason for setting a screening blood testosterone level was to exclude women with high testosterone levels to minimize the likelihood of androgenisation. We agree that there is no level of testosterone that correlates with low self-reported sexual wellbeing2. Although the maximal benefit appeared to be in the women receiving one 90 -µL dose per day, when we looked at all of the data across the study rather than just the final month there was a much stronger signal and results were significant for both the 1x 90-µL dose and 2x 90 -µL dose . We are in agreement that sexual function is extremely complex. However to undertake a study that takes into account all the major influences on sexual wellbeing and satisfaction would be extremely ambitious. That we demonstrated an effect of testosterone therapy, albeit modest, over and above the inherent background ‘noise’ in this study indicates that testosterone independently influences female sexual function. 1. Davis SR, Papalia MA, Norman RJ, et al. Safety and Efficacy of a Testosterone Metered-Dose Transdermal Spray for treatment of decreased sexual satisfaction in Premenopausal Women: A Placebo-Controlled Randomized, Dose-Ranging Study. . Annals Internal Med. 2008;148:569-577. 2. Davis SR, Davison SL, Donath S, Bell RJ. Circulating androgen levels and self-reported sexual function in women. JAMA. Jul 6 2005;294(1):91-96. |
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Liu Hong, PhD Institute of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, China, Kaichun Wu, Daiming Fan
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hlhyhj{at}126.com Liu Hong, et al.
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To the editor: We read with interest the article by Davis and colleagues [1]. They clearly show that a daily 90-ul dose of transdermal testosterone improves self-reported sexual satisfaction for premenopausal women with reduced libido and low serum-free testosterone levels. The report evaluates many factors associated with the sexual satisfaction of women, such as age, premenopausal status, body mass index, sexual activity, depression, testosterone level, pregnancy, relationship problems, medication, and so on. However, they don't clearly show the factors affecting their partners. If the sexual activity is with a partner, clinicians will need to know the effect of partner on the sexual satisfaction in premenopausal women. The readers will strongly suggest a more detailed follow-up. For example, does the partner keep the same one? What about the health and relationship activity of the partner? Could the authors comment on the sexual satisfaction of a woman whose partner is always sitting in the office, as compared to one whose partner is keeping doing physical exercises? The placebo effect is strong, indicating more factors should be considered in the evaluation. The environment also affects the sexual satisfaction in premenopausal women. It is assumed to be different for a novel place, as compared to the same bed. Could the authors comment on the potential effect of environment on the sexual satisfaction in premenopausal women? References: 1. Davis S, Papalia MA, Norman RJ et al. Safety and efficacy of a testosterone metered-dose transdermal spray for treating decreased sexual satisfaction in premenopausal women: a randomized trial. Annals Intern Med 2008; 148: 569-577. Conflict of Interest:None declared |
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Hari KVS Kumar, MD Medwin Hospitals, Hyderabad, India, Muthukrishnan J, Modi KD
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hariendo{at}rediffmail.com Hari KVS Kumar, et al.
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To The Editor Annals of Internal Medicine We have some comments regarding the study of testosterone replacement in Premenopausal Women by Dr Davis and colleagues (1). 1) The inclusion criteria specified for the study participants was early morning free testosterone level of 3.8 pmol/L or less. However, the mean free testosterone level at baseline as shown in Table 3 is more than 6 pmol/L in all the study groups. This appears contrary to the defined inclusion criteria. 2) Out of the 480 symptomatic, screened woman initially, 168 (35%) were ineligible because of free testosterone level above the cutoff value (3.8 pmol/L). This highlights the fact that androgen levels are not related to the sexual dysfunction in women as reported earlier (2). 3) Use of oral contraceptive pills result in suppression of free and total testosterone level and may contribute to decreased libido (3). In the study, the maximum benefit is seen in the group using daily 90 µL dose of transdermal testosterone. Baseline characteristics show that more number of patients of the same group was using oral contraceptives in relation to others (34% vs 2% in placebo).Could this be the contributing factor behind the observed benefit in this group? References: 1) Davis S, Papalia MA, Norman RJ et al. Safety and efficacy of a Testosterone Metered-Dose Transdermal spray for treating Decreased Sexual Satisfaction in Premenopausal Women. Annals Intern Med 2008; 148: 569-577. 2) Santoro N, Torrens J, Crawford S et al. Correlates of circulating androgens in mid-life women: the study of women’s health across the nation. J Clin Endocrinol Metab. 2005; 90 : 4836-4845. 3) Martin-Loeches M, Orti RM, Monfort M, Ortega E, Rius J. A comparative analysis of the modification of sexual desire of users of oral hormonal contraceptives and intrauterine contraceptive devices. Eur J Contracept Reprod Health Care 2003; 8: 129-134. Conflict of Interest:None declared |
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