Trial Outcomes & Findings for Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder (NCT NCT04179734)

NCT ID: NCT04179734

Last Updated: 2024-08-09

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: Baseline and 15 minutes
• Results posted on: 2024-08-09

Participant Flow

Participant milestones

Measure	Bremelanotide First, Then Placebo Participants attended 2 study visits each: first visit (6 hours) for subcutaneous administration of Bremelanotide 1.75 mg/0.3 mL then at least one month later a second visit (6 hours) for subcutaneous administration of equivalent volume Placebo. This was to ensure full washout between visits and to allow the study to be performed at the same stage of the participant's menstrual cycle each time.	Placebo First, Then Bremelanotide Participants attended 2 study visits each: first visit (6 hours) for subcutaneous administration of equivalent volume Placebo then at least one month later a second visit (6 hours) for subcutaneous administration of Bremelanotide 1.75 mg/0.3 mL. This was to ensure full washout between visits and to allow the study to be performed at the same stage of the participant's menstrual cycle each time.
Group 1 Bremelanotide, Group 2 Placebo STARTED	20	20
Group 1 Bremelanotide, Group 2 Placebo COMPLETED	20	20
Group 1 Bremelanotide, Group 2 Placebo NOT COMPLETED	0	0
Group 1 Placebo, Group 2 Bremelanotide STARTED	20	20
Group 1 Placebo, Group 2 Bremelanotide COMPLETED	16	15
Group 1 Placebo, Group 2 Bremelanotide NOT COMPLETED	4	5

Reasons for withdrawal

Measure	Bremelanotide First, Then Placebo Participants attended 2 study visits each: first visit (6 hours) for subcutaneous administration of Bremelanotide 1.75 mg/0.3 mL then at least one month later a second visit (6 hours) for subcutaneous administration of equivalent volume Placebo. This was to ensure full washout between visits and to allow the study to be performed at the same stage of the participant's menstrual cycle each time.	Placebo First, Then Bremelanotide Participants attended 2 study visits each: first visit (6 hours) for subcutaneous administration of equivalent volume Placebo then at least one month later a second visit (6 hours) for subcutaneous administration of Bremelanotide 1.75 mg/0.3 mL. This was to ensure full washout between visits and to allow the study to be performed at the same stage of the participant's menstrual cycle each time.
Group 1 Placebo, Group 2 Bremelanotide Withdrawal by Subject	4	3
Group 1 Placebo, Group 2 Bremelanotide Abnormal structural findings on MRI	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Bremelanotide First, Then Placebo n=16 Participants Participants attended 2 study visits each: first visit (6 hours) for subcutaneous administration of Bremelanotide 1.75 mg/0.3 mL then at least one month later a second visit (6 hours) for subcutaneous administration of equivalent volume Placebo. This was to ensure full washout between visits and to allow the study to be performed at the same stage of the participant's menstrual cycle each time.	Placebo First, Then Bremelanotide n=15 Participants Participants attended 2 study visits each: first visit (6 hours) for subcutaneous administration of equivalent volume Placebo then at least one month later a second visit (6 hours) for subcutaneous administration of Bremelanotide 1.75 mg/0.3 mL. This was to ensure full washout between visits and to allow the study to be performed at the same stage of the participant's menstrual cycle each time.	Total n=31 Participants Total of all reporting groups
Age, Continuous	29 years n=93 Participants	29 years n=4 Participants	29 years n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	15 Participants n=4 Participants	31 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=93 Participants	14 Participants n=4 Participants	29 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United Kingdom	16 participants n=93 Participants	15 participants n=4 Participants	31 participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 15 minutes

Population: A final group of 31 premenopausal women with HSDD participated in a randomized, double-blinded, 2-way crossover, placebo- controlled study. They attended 2 study visits each: 1 for subcutaneous administration of Bremelanotide and 1 for subcutaneous administration of an equivalent volume of placebo in random order, at least 1 month apart.

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).

Outcome measures

Measure	Bremelanotide n=31 Participants Participants were administered a subcutaneous injection of the melanocortin-4 receptor agonist (MC4Ra) Bremelanotide.	Placebo n=31 Participants Participants were administered a subcutaneous injection of equivalent volume of placebo.
Changes in Blood Oxygen Level Dependent (BOLD) Signal Change on Functional MRI	9.98 BOLD signal change	7.67 BOLD signal change

Adverse Events

Bremelanotide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Waljit S. Dhillo, Principal Investigator

Imperial College London

Phone: 00442075943487

Email: w.dhillo@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place