Publications by authors named "L R Derogatis"

Background: The Elements of Desire Questionnaire (EDQ) is a patient-reported outcome (PRO) measure developed to evaluate sexual desire and was included in two identically designed phase 3 clinical trials (RECONNECT) as an exploratory endpoint. The EDQ was developed based on a literature review, qualitative research with patients with hypoactive sexual desire disorder (HSDD), and input from clinical experts. This instrument is intended to be used to collect efficacy data in clinical trials evaluating potential treatments for HSDD.

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Screening, diagnosis, and management of hypoactive sexual desire disorder (HSDD) and research into the condition have been challenging due to its biopsychosocial complexity and lack of consensus on relevant measures. Although physician interviews yield much clinically valid information, self-reported questionnaires appear more acceptable to patients and physicians. Consequently, validated patient-reported outcome (PRO) tools are essential for evaluation and management of HSDD, including any therapeutic intervention.

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Objective: To quantify the association between vulvovaginal atrophy and depression, major depressive disorder, and anxiety.

Methods: Women with vulvovaginal atrophy from the Truven Health MarketScan Commercial and Medicare Supplemental Databases (01/2010-09/2016) with ≥365 days of continuous insurance coverage before and after the first vulvovaginal atrophy/dyspareunia diagnosis (index date) were selected. Women with vulvovaginal atrophy were matched 1:3 to women without (controls) according to age, calendar year, health plan, and region.

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Article Synopsis
  • Responder analyses are crucial for assessing if changes in clinical trials, especially those focused on patient-reported outcomes related to female sexual health, are clinically meaningful.
  • The study aimed to determine the minimal clinically important difference (MCID) for scores on questionnaires related to female sexual functioning during a trial of the drug bremelanotide for women with hypoactive sexual desire disorder (HSDD) and related conditions.
  • Results showed significant improvements at the 1.75 mg dose across all evaluated endpoints compared to placebo, aligning with expert estimates for clinically meaningful differences.
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