CompletedPhase 4

Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder

United Kingdom40 participantsStarted 2019-10-07

Plain-language summary

A randomised, double-blind, placebo-controlled, two-way crossover physiological study. Designed to evaluate the effects of melanocortin-4 receptor (MC4R) activation on brain activity patterns and behavioural psychometric measures of sexual arousal during visual erotic stimuli in approximately 40 right-handed, heterosexual, premenopausal women aged 18 years and over with Hypoactive Sexual Desire Disorder (HSDD) for at least a 6 month duration.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001) total score is \<10.
✓. PHQ-9 score for Question 9 is 0.
✓. Either Female Sexual Function Index (FSFI) total score ≤26 if diagnosed with HSDD (with or without symptoms of decreased arousal) or subjects diagnosed with HSDD only (without symptoms of decreased arousal), FSFI desire domain score of ≤5 (regardless of total FSFI score).
✓. Female Sexual Distress Scale - Desire/Arousal/Orgasm (FSDS-DAO) total score is \>18.

Exclusion criteria

✕. Two sequential assessments (seated, approximately 4 minutes apart and no more than 15 minutes apart) with readings above 140 mmHg systolic BP or 90 mmHg diastolic BP, and upon repeat at least 24 hours later.
✕. Treatment for hypertension that has been changed at least once in the 4 weeks prior to Screening.
✕. Implanted or injected testosterone product within 6 months of Screening.
✕. Within 3 months of Screening:
✕. Psychosis, bipolar disorder, depression, and/or alcohol/substance abuse; depression or alcohol/substance abuse that resolved \>1 year prior to Screening/Visit 1 will not be exclusionary.
✕. Prior suicide attempt or increased suicidality as indicated by a score greater than zero on Questions 1-5 inclusive (interpreted increased risk) and/or Question 20 (interpreted history of suicide) of the Beck Scale for Suicidal Ideation (BSS),

What they're measuring

Changes in Blood Oxygen Level Dependent (BOLD) Signal Change on Functional MRI

Timeframe: Baseline and 15 minutes

Trial details

NCT IDNCT04179734

SponsorImperial College Healthcare NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-06

Results submitted2023-04-20

View on ClinicalTrials.gov More Hypoactive Sexual Desire Disorder trials