Changes in Blood Oxygen Level Dependent (BOLD) Signal Change on Functional MRI
| Group | Value (BOLD signal change) |
|---|---|
| Bremelanotide | 9.98 |
| Placebo | 7.67 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataUnited Kingdom
1 trial · 1 completed · 1 with posted results
Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder
NCT041797347 Oct 2019 to 6 Oct 2020
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.
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.
Outcomes the sponsor listed as primary.
Changes in Blood Oxygen Level Dependent (BOLD) Signal Change on Functional MRI
Time frame · Baseline and 15 minutes
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).
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (BOLD signal change) |
|---|---|
| Bremelanotide | 9.98 |
| Placebo | 7.67 |
| Group | Deaths | Serious events | Other 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 / 31 | 0 / 31 | 0 / 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 / 31 | 0 / 31 | 0 / 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
Studies that cite this trial.
2 studies on this page
Indexing hint: Randomized controlled trial · 2019
Kingsberg et al. 2019Obstetrics and gynecologycited by 95
PMID 31599840PMC6819021DOI 10.1097/aog.0000000000003500PUB-31599840
Indexing hint: Animal study · 2004
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
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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