Clinically Relevant Changes in Sexual Desire, Satisfying Sexual Activity and Personal Distress as Measured by the Profile of Female Sexual Function, Sexual Activity Log, and Personal Distress Scale in Postmenopausal Women with Hypoactive Sexual Desire Disorder

Abstract

Introduction Transdermal testosterone patch (TTP) treatment produced statistically significant improvements in a satisfying sexual activity (SSA), sexual desire, and personal distress in postmenopausal women suffering from hypoactive sexual desire disorder (HSDD), but clinical significance of these changes was not determined. Aim To quantify the magnitude of change in three principal outcomes measures determined by HSDD patients as associated with the perception of meaningful benefit with TTP therapy. Methods The criteria for defining responders were determined using anchoring methodology and receiver operating characteristics analysis to establish minimum important differences (MIDs) in a representative subsample of 132 patients in two randomized, controlled trials in surgically menopausal women with HSDD (N = 1,094). Perceived benefit was established based upon the question “Overall, would you say that you experienced a meaningful benefit from the study patches?”. These data defined responders and established MIDs for changes in sexual desire, SSA, and personal distress. The MIDs were applied to the two trials to establish responder rates in each treatment group. Main Outcome Measures Changes in score that correspond to the MID for sexual desire, SSA, and personal distress, and responder rates in each treatment group based upon these values. Results Increases in frequency of SSA of greater than 1 activity/4 weeks, increases in sexual desire score of ≥8.9, and decreases in the personal distress score of ≥20.0 were identified as threshold improvements best able to differentiate responders and nonresponders. The responder rate was significantly higher (P < 0.001) in the testosterone group vs. placebo for all three outcomes measures (sexual desire, 50% vs. 34%; SSA, 44% vs. 30%; personal distress, 51% vs. 39%). Conclusions Changes in sexual desire, SSA, and personal distress observed with TTP treatment in surgically menopausal women with HSDD were clinically significant and were associated with a meaningful treatment benefit.

Methods for Specifying the Target Difference in a Randomised Controlled Trial: The Difference ELicitation in TriAls (DELTA) Systematic Review

“…Another common variation is to consider the percentage change score in the instrument under consideration [33], rather than the absolute score change. Determination of what constituted an important difference was sometimes based upon the use of methodology more typically used to assess diagnostic accuracy, such as receiver operating characteristic curves [6],[11],[20], or more complex statistical approaches. It is worth noting that the anchor method was not always successful in deriving values for an important difference; failure was usually due to either practical or methodological difficulties [17],[23].…”

Gepirone-ER Treatment of Low Sexual Desire Associated with Depression in Women as Measured by the DeRogatis Inventory of Sexual Function (DISF) Fantasy/Cognition (Desire) Domain—A Post Hoc Analysis

“…The question [31] always arises: are these results clinically significant? The DISF has been normalized to the general population.…”

Evaluation of a rural nurse-led clinic for female sexual dysfunction

“…1 Female sexual dysfunction can include a decrease in sexual desire and arousal, altered or absent orgasm, and dyspareunia. Recent findings from the Australian Longitudinal Study of Health and Relationships found that two thirds of Australian women experienced one or more sexual difficulties, of which at the 12 month follow-up persisted in nearly three quarters of the women and with one third reporting a new difficulty.…”