PT-141 - 10mg

NCT06867835 · COMPLETED

Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk

The primary objectives of this clinical trial performed with Vyleesi (Bremelanotide Injection) are: * to evaluate if Bremelanotide (BMT) is secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC. * to measure the concentration and characterize the pharmacokinetics of BMT secreted in breast milk of lactating women treated with a single dose of BMT 1.75 mg SC. This open-label, pharmacokinetic (PK) study will be performed in 10 healthy lactating female subjects between 10 days and 6 months post-partum (inclusive). The maximum duration of subject participation in the study will be approximately 29 days, consisting of 3-week Screening period, a 1 day treatment period, and up to a 7 day follow-up period.

Outcomes: Levels of Bremelanotide (BMT) in Breast Milk Over 24h After Administration of Vyleesi · Area under the curve from time 0 to end of dosing interval (AUCtau) for BMT in Breast Milk · Maximum observed concentration (Cmax) of BMT in breast milk · Time to reach Cmax of BMT in breast milk (Tmax) · Terminal half-life of BMT in breast milk (t1/2) · Levels of Bremelanotide (BMT) in Plasma Over 24h After Administration of Vyleesi · Area under the curve from time 0 to end of dosing interval (AUCtau) for BMT in Plasma · Maximum observed concentration (Cmax) of BMT in Plasma · Time to reach Cmax of BMT in Plasma (Tmax) · Milk:plasma ratio (M/P) of BMT Levels

NCT00425256 · COMPLETED

Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)

This 8 week at home study is designed to explore efficacy endpoints and evaluate the safety of intranasal Bremelanotide in women with Female Sexual Arousal Disorder. Efficacy will be assessed vs. a parallel placebo group.

NCT02338960 · COMPLETED

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

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without decreased arousal) in premenopausal females.

Outcomes: Efficacy of a Fixed Dose of Bremelanotide as Measured by FSFI (Question Q1 and Q2), 28-day Recall. · Efficacy of a Fixed Dose of Bremelanotide as Measured by FSDS-DAO (Item 13) · Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study (EOS) in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration · Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Desire Score (Q3) From the FSEP-R · Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R · Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSDS-DAO Total Score · Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the FSFI Total Score · Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Level of Sexual Arousal (Q6) From the FSEP-R · Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Mean Satisfaction With Sexual Arousal (Q7) From the FSEP-R · Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Scored Time Spent Being Concerned by Difficulty With Sexual Arousal (Q14) From the FSDS-DAO · Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Arousal Domain of the FSFI (Q3 to Q6) · Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Total Number of SSEs · Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Desire Domain of the FSFI (Q1 to Q2) Throughout the Entirety of the Double-blind Phase · Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Score for Feeling Bothered by Low Sexual Desire as Measured by the FSDS-DAO (Item 13) Throughout the Entirety of the Double-blind Phase · Efficacy of a Fixed Dose of Bremelanotide, as Measured by the Change in Baseline to End of Study in the Number of SSEs Associated With Study Drug Administration Throughout the Entirety of the Double-blind Phase

Results summary: {"participantFlowModule":{"preAssignmentDetails":"Core Study: 703 participants enrolled, 89 run-in failures 614 participants were randomized.\n\nOLE Study (optional): Of the 392 completers of the Core study, 321 participants enrolled in optional OLE study. The OLE Study was not reported.","recruitmentDetails":"Core (\"Main\") Study consisted of a 4-week no drug Screening period, followed by a 4-week single blind PBO period, first dose administered in-clinic. Following the end of single-blind period, which served as Baseline, eligible subjects were then randomized to a 24-week double-blind outpatient treatment period, first dose administered in-clinic.","groups":[{"id":"FG000","title":"Placebo PBO/BMT","description":"Core Study: Subjects will self-administer a fixed dose of placebo subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks.\n\nPlacebo\n\nOLE Study: Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 52 weeks.\n\nbremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"},{"id":"FG001","title":"Brememlanotide BMT/BMT","description":"Core and OLE Study: Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours for 24 weeks.\n\nbremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"}],"periods":[{"title":"Core Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"306"},{"groupId":"FG001","numSubjects":"308"}]},{"type":"Received Intervention","achievements":[{"groupId":"FG000","numSubjects":"303"},{"groupId":"FG001","numSubjects":"301"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"219"},{"groupId":"FG001","numSubjects":"173"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"87"},{"groupId":"FG001","numSubjects":"135"}]}]},{"title":"Open Label Extension","milestones":[{"type":"STARTED","comment":"321/392 Subjects who completed the Core Study continued into the optional OLE study.","achievements":[{"groupId":"FG000","numSubjects":"191"},{"groupId":"FG001","numSubjects":"130"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"77"},{"groupId":"FG001","numSubjects":"51"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"114"},{"groupId":"FG001","numSubjects":"79"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Randomized population = 614, of which 10 were not dosed, leaving 604 participants. A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into the optional OLE Study Phase, including 130 in the BMT group (BMT-BMT) and 191 in the PBO group (PBO-BMT)","groups":[{"id":"BG000","title":"Bremelanotide (BMT/BMT)","description":"Subjects will self-administer a fixed dose of bremelanotide (BMT) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours (Main) followed by a 52-week open label extension study (OLE)\n\nBMT/BMT\n\nbremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"},{"id":"BG001","title":"Placebo (PBO/BMT)","description":"Subjects will self-administer a fixed dose of placebo (PBO) subcutaneously (SC) via auto-injector on an as needed basis with no more than 1 dose taken every 24 hours (Main) followed by a 52-week open label extension study (OLE) where participants receive only BMT, no placebo\n\nPBO/BMT\n\nPlacebo: Placebo bremelanotide: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"303"},{"groupId":"BG001","value":"301"},{"groupId":"BG002","value":"604"}]}],"measures":[{"title":"Age, Continuous","populationDescription":"A total 321 of the 392 (81.9%) subjects who completed the Core Study Phase continued into OLE Study Phase, including 130 in the BMT group (BMT/BMT) and 191 in the PBO group (PBO/BMT).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"title":"Main","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"303"},{"groupId":"BG001","value":"301"},{"groupId":"BG002","value":"604"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"38.5","spread":"7.19"},{"groupId":"BG001","value":"39.1","spread":"6.96"},{"groupId":"BG002","value":"38.8","spread":"7.08"}]}]},{"title":"OLE","denoms":[{"units":"P

NCT04943068 · COMPLETED

A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)

The purpose of this study is to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women with Hypoactive Sexual Desire Disorder(with or without Decreased Arousal).

Outcomes: Change from baseline to End of Study in the desire domain from the FSFI · Change from baseline to End of Study in FSDS-DAO (Item 13) · Change from Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration · Change from Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R · Change from Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R · Change from Baseline to End of Study in the FSDS-DAO Total Score · Change from Baseline to End of study in the total FSFI score based on the 19 questions · Change in mean Level of Sexual Arousal from FSEP-R Q6 · Change in mean Satisfaction with Sexual Arousal from FSEP-R Q7. · Change from Baseline to End of study in the scored time spent being concerned by difficulty with sexual arousal as measured by the FSDS-DAO Q14. · Change from Baseline to End of study in the arousal domain from the FSFI Q3 through Q6. · Change from Baseline to End of study in the total number of SSEs. · Change from baseline in the desire domain from the FSFI Q1 and Q2 using all available double-blind data (visit 4, 5) · Change from baseline in the score for feeling bothered by low sexual desire as measured by the FSDS -DAO Q13 using all available double-blind data(visit 4, 5) · Change from baseline in the number of SSEs associated with study drug using the entire 8 weeks of the double-blind phase.

NCT03973047 · COMPLETED

Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran

This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing.

Outcomes: Incidence of treatment-emergent nausea following BMT with or without concomitant use of Zofran. · Severity of nausea using a Visual Analog Scale · Time to onset of nausea · Duration of nausea

NCT04179734 · COMPLETED

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

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.

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

Results summary: {"participantFlowModule":{"groups":[{"id":"FG000","title":"Bremelanotide First, Then Placebo","description":"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."},{"id":"FG001","title":"Placebo First, Then Bremelanotide","description":"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."}],"periods":[{"title":"Group 1 Bremelanotide, Group 2 Placebo","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"20"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"20"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Group 1 Placebo, Group 2 Bremelanotide","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"20"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Abnormal structural findings on MRI","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Bremelanotide First, Then Placebo","description":"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."},{"id":"BG001","title":"Placebo First, Then Bremelanotide","description":"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."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"31"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"29","lowerLimit":"25","upperLimit":"36"},{"groupId":"BG001","value":"29","lowerLimit":"25","upperLimit":"36"},{"groupId":"BG002","value":"29","lowerLimit":"25","upperLimit":"36"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"31"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"29"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United Kingdom","categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"31"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Changes in Blood