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

Revicki DA, Althof SE, Derogatis LR, Kingsberg SA, Wilson H, Sadiq A, Krop J, Jordan R, Lucas J

Journal of patient-reported outcomes8 Oct 2020Cited by 5 (Europe PMC)

PMID33033885PMCIDPMC7544783DOI10.1186/s41687-020-00241-6PepBankPUB-33033885

Summary

BackgroundThe 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.MethodsParticipants 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.ResultsAt 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).ConclusionsThe 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 registrationNCT02338960 and NCT02333071 (RECONNECT studies).

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study1

1 result from studies that gave the peptide. 1 result from people.

01HumanRandomized controlled trialEfficacy outcome
In premenopausal women with hypoactive sexual desire disorder, bremelanotide improved Elements of Desire Questionnaire scores more than placebo after 6 months, in both monthly and daily recall versions.
In plain wordsIn premenopausal women with low sexual desire, bremelanotide improved desire questionnaire scores more than placebo after 6 months.
Peptide
Bremelanotide (PT-141)
Outcome
IncreaseElements of Desire Questionnaire improvement at 6 months (monthly and daily recall)
Study
n: not reported in source
Comparator
Placebo
Analysis
Exploratory
Outcome group
Sexual function · Reproductive and sexual health
Studied dose
Dose not stated · 6 monthsAs given in this study (human).
Source sentences
Summary
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).
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-3303388501

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Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT02338960

2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

Palatin Technologies, Incn = 714Jan 2015 to 29 Jun 2017

Hypoactive Sexual Desire Disorder

Trial page ClinicalTrials.govUpdated 28 Jan 2021

CompletedPhase 3Results postedNCT02333071

1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder

Palatin Technologies, Incn = 723Dec 2014 to 30 Jun 2017

Hypoactive Sexual Desire Disorder

Trial page ClinicalTrials.govUpdated 9 Apr 2021

Version history

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Version 2Current
9 Oct 2026, 18:17 UTC
Study results updated
Version 1
9 Oct 2026, 03:04 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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