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Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

Overview

Status
Completed
Phase
Phase 4
Enrollment
40 participants (actual)
Sponsor
Imperial College Healthcare NHS Trust · Other
Design
Randomized · Quadruple masking
Countries
1 country

United Kingdom

Start
7 Oct 2019
Primary completion
6 Oct 2020
Completion
6 Oct 2020
First posted
27 Nov 2019
Last update posted
9 Aug 2024
Conditions
Hypoactive Sexual Desire Disorder

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 4

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

    NCT04179734

    7 Oct 2019 to 6 Oct 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • BremelanotideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Intervention

    Bremelanotide 1.75 mg - prefilled subcutaneous autoinjector containing 1.75 mg Bremelanotide in a 0.3 mL solution volume.

  • Placebo comparator

    Placebo

    1.75 mg equivalent - prefilled subcutaneous autoinjector containing Bremelanotide formulation without the active ingredient in a 0.3 mL solution volume.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline and 15 minutes

    Registry description

    Blood Oxygen Level Dependent (BOLD) imaging was used to detect activation clusters within the brain. Units of measure were standardised regression coefficients derived from the regression analysis that were used to fit the analysis model to the time-series data (BOLD signal change). Higher BOLD signal change values indicate increased activation in particular areas of the brain in response to the intervention (Bremelanotide or Placebo).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline and 15 minutes

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

GroupValue (BOLD signal change)
Bremelanotide9.98
Placebo7.67

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
BremelanotideAll 31 participants received Bremelanotide. 16 participants received Bremelanotide on their first study visit and 15 participants received Bremelanotide on their second study visit in this randomized, double-blinded, 2-way crossover study.0 / 310 / 310 / 31
PlaceboAll 31 participants received Placebo. 15 participants received Placebo on their first study visit and 16 participants received Placebo on their second study visit in this randomized, double-blinded, 2-way crossover study.0 / 310 / 310 / 31

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2019

6 results

Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.

Kingsberg et al. 2019Obstetrics and gynecologycited by 95

PMID 31599840PMC6819021DOI 10.1097/aog.0000000000003500PUB-31599840

Free to read · publisher termsCC BY-NC-ND6 results

Indexing hint: Animal study · 2004

6 results

Selective facilitation of sexual solicitation in the female rat by a melanocortin receptor agonist.

Pfaus et al. 2004Proceedings of the National Academy of Sciences of the United States of Americacited by 83

PMID 15226502PMC454387DOI 10.1073/pnas.0400491101PUB-15226502

Rights unknown6 results

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultThurston L, Hunjan T, Mills EG, Wall MB, Ertl N, Phylactou M, Muzi B, Patel B, Alexander EC, Suladze S, Modi M, Eng PC, Bassett PA, Abbara A, Goldmeier D, Comninos AN, Dhillo WS. Melanocortin 4 receptor agonism enhances sexual brain processing in women with hypoactive sexual desire disorder. J Clin Invest. 2022 Oct 3;132(19):e152341. doi: 10.1172/JCI152341. PMID 36189794

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Heterosexual premenopausal females ≥ 18 years of age with normal menstrual cycles ≤ 35 days. * Right hand dominant. * Body mass index (BMI) 18-35kg/m2. * Currently in a relationship with a male partner and the relationship has been stable for at least 6 months before screening. * Male sexual partner classified as "not impotent" on the Massachusetts Male Aging Study (MMAS) single-question assessment of erectile dysfunction. * In the subject's opinion, previously experienced "normal sexual function," defined as a normal level of desire at some point in the past, for a period of at least 2 years. * For all subjects of childbearing potential who are sexually active, agree to routinely use adequate non-hormonal contraception from randomisation throughout the duration of the study and for 30 days after. * For at least 6 months before Screening, met the diagnostic criteria for HSDD according to the Diagnostic Screening Guide for HSDD, including categorisation of the sexual dysfunction as both acquired (versus lifelong) and generalised (versus situational). * All of the following at Screening: 1. Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001) total score is \<10. 2. PHQ-9 score for Question 9 is 0. <!-- --> 1. 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). 2. Female Sexual Distress Scale - Desire/Arousal/Orgasm (FSDS-DAO) total score is \>18. * Capable of understanding and complying with the protocol requirements and available for the duration of the study. * Subjects must have prior experience in viewing sexually explicit material. Exclusion Criteria: * Cardiovascular disease * Current diagnosis of uncontrolled hypertension defined as: 1. 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. 2. Treatment for hypertension that has been changed at least once in the 4 weeks prior to Screening. * Any other medical condition that is unstable or uncontrolled despite current therapy. * Previously received Bremelanotide. * A history of unresolved sexual trauma or abuse. * Female subjects who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test, or are not willing to use effective contraceptive precautions during the study. * Participated in any research study within the preceding 30 days of screening. * Any FSD other than acquired HSDD with or without decreased arousal (e.g. lifelong anorgasmia, sexual pain disorder, sexual aversion disorder, primary female sexual arousal disorder). * FSD caused by untreated endocrine disease (e.g. hypopituitarism, hypothyroidism, diabetes mellitus). * Acute or chronic hepatitis. * In the Investigator's opinion, any urologic or gynecologic condition, such as condyloma, uterine fibroids, vulvar or vaginal lesions, vulvodynia, vaginismus, or pelvic pain that may contribute to impaired sexual activity and function or be a cause of the FSD or that may interfere with the subject's ability to comply with study procedures. * Receiving any treatment for HSDD (e.g. psychotherapy, physical therapy) at the time of Screening. * Has used any of the following types of medications, which are prohibited during the study: 1. Implanted or injected testosterone product within 6 months of Screening. 2. Within 3 months of Screening: * Neuroleptics (e.g. risperidone) * Lithium (e.g. lithium carbonate) * Antidepressants (e.g. amitriptyline, fluoxetine, bupropion) * Mood stabilisers (e.g. valproate) * Benzodiazepines (e.g. lorazepam, diazepam) * Cognitive enhancers or stimulants (e.g. donepezil or Adderall®) * Centrally-acting antihypertensives (e.g. clonidine) * Any other prescription, non-prescription, hormonal, herbal, or nutritional medication or supplement that the investigators believe would confound the results of the study (e.g. St. John's wort, black cohosh, dehydroepiandrosterone, dehydroepiandrosterone sulfate) * γ-Aminobutyric acid agonists (e.g. Ambien® \[zolpidem\], Lunesta® \[eszopiclone\]) c. Topical or systemic androgen therapy within 30 days of Screening. d. Subject is unwilling or unable to refrain from using the aforementioned products for the duration of the study. * Mental health history that includes any of the following: 1. 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. 2. 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), * Any abnormality in vision that would impair viewing images. * Any contraindication to MRI or otherwise unable to undergo an MRI (e.g. pacemaker, recent wound clips, severe claustrophobia, unable to lay flat). * Any other condition or subject responsibility that in the Investigator's opinion may interfere with a subject's ability to give informed consent or adhere to the protocol or has the potential to interfere with the studied endpoints or serves as a contraindication to the subject's participation in the study.

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