Reliability and validity of the elements of desire questionnaire in premenopausal women with hypoactive sexual desire disorder

Abstract

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. The objective of this study was to evaluate the measurement properties of both the monthly and daily recall versions of the EDQ during the RECONNECT trials.

Methods: Participants completed the EDQ daily version for 7 consecutive days prior to selected monthly clinic visits. The monthly recall version was completed at each monthly clinic visit. The analysis population consisted of all subjects with Female Sexual Function Index (FSFI) data at baseline and ≥ 1 follow-up visit.

Results: At baseline, 1144 and 676 subjects completed the monthly and daily recall EDQs, respectively. The EDQ scores had good internal consistency and test-retest reliability. Monthly and daily recall EDQ scores were correlated with FSFI-desire domain scores at baseline and month 3. Scores from the monthly and daily recall versions were also correlated. After 6 months, there was a significantly greater improvement for bremelanotide versus placebo in both the monthly and daily recall versions (both P < 0.0001).

Conclusions: The results demonstrated that EDQ exhibited good reliability, validity, and sensitivity to change. Consistent with other validated PRO measures of sexual desire, the EDQ provides additional insights into sexual desire.

Trial registration: NCT02338960 and NCT02333071 (RECONNECT studies).

Keywords: Bremelanotide; Female sexual dysfunction; Hypoactive sexual desire disorder; Patient-reported outcomes; Validation.

Conflict of interest statement

DAR was an employee of Evidera at the time of the study, and the company received funding from Palatin Technologies, Inc.; DAR has received consulting fees and research support from Palatin Technologies, Inc., Viveve Medical, and AMAG Pharmaceuticals, Inc.

SEA has served on advisory boards and has been a consultant for AMAG Pharmaceuticals, Inc., Palatin Technologies, Inc., Ixchelsis, Promescent, Strategic Science Technologies, and Valeant/Sprout. He has been a principal investigator for Clinical Outcomes Solutions, Endoceutics, and Ixchelsis, and he has served on the speakers’ bureau for Valeant.

LRD has no conflicts of interest to disclose.

SAK has served on advisory boards or has been a consultant for AMAG Pharmaceuticals, Inc., Astellas Pharma US, Inc., Duchesnay, Emotional Brain, Endoceutics, Ivix, Pfizer, Shionogi, Materna, TherapeuticsMD, SST, Lupin Pharmaceuticals, Inc., Palatin Technologies, Inc., and Sprout Pharmaceuticals, Inc. She has stock options in Viveve Medical.

HW was an employee of Evidera, which has received funding from Palatin Technologies, Inc., at the time of the study.

AS and JK are employees and stockholders of AMAG Pharmaceuticals, Inc.

RJ is an employee and a stockholder of Palatin Technologies, Inc.

JL was an employee of Palatin Technologies, Inc. at the time of the study.

Figures

Fig. 1

Mean EDQ total score by treatment group (BMT vs. placebo) across study visits in the integrated phase 3 RECONNECT studies – monthly recall version. BMT, bremelanotide; EDQ, Elements of Desire Questionnaire. *The mean EDQ total score for the monthly recall version was calculated as the mean of individual items (1–9) and does not represent the sum of all items. Scores range from 1 (lowest desire) to 5 (highest desire)

Fig. 2

Mean EDQ total score by treatment group (BMT vs. placebo) across study visits in the integrated phase 3 RECONNECT studies – daily recall version. BMT, bremelanotide; EDQ, Elements of Desire Questionnaire. *The mean EDQ total score for the 24-h recall version was calculated as the mean of items 1, 2, 3, 4, 6, 8, and 9. Scores range from 1 (lowest desire) to 5 (highest desire). The mean score for each item was calculated for each day, and then a weekly score was calculated using these daily total scores. Data from at least 4 of the 7 days in the week were required to generate a weekly mean