Clinical trial NCT04943068: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypoactive Sexual Desire Disorder
Keywords: KD-BMT-301
Bremelanotide
Lead sponsor: Kwang Dong Pharmaceutical co., ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-29
Enrollment: 193
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: \[Main Inclusion Criteria\]

* Has met diagnostic criteria for HSDD for at least 6 months
* Is willing and able to understand and comply with all study requirements
* Has a normal pelvic examination at screening

\[Main Exclusion Criteria\]

* Subjects should be generally healthy premenopausal females with no psychological, gynecological or urological conditions which might contribute to the sexual dysfunction, compromise study participation, or confound interpretation of the study results
* Not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial

Primary outcomes:
measure: Change from baseline to End of Study in the desire domain from the FSFI
timeFrame: Baseline up to End of Study(8weeks)
Secondary outcomes:
measure: Change from baseline to End of Study in FSDS-DAO (Item 13)
timeFrame: Baseline up to End of Study(8weeks)
measure: Change from Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration
timeFrame: Baseline up to End of Study(8weeks)
measure: Change from Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R
timeFrame: Baseline up to End of Study(8weeks)
measure: Change from Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R
timeFrame: Baseline up to End of Study(8weeks)
measure: Change from Baseline to End of Study in the FSDS-DAO Total Score
timeFrame: Baseline up to End of Study(8weeks)
measure: Change from Baseline to End of study in the total FSFI score based on the 19 questions
timeFrame: Baseline up to End of Study(8weeks)
measure: Change in mean Level of Sexual Arousal from FSEP-R Q6
timeFrame: Baseline up to End of Study(8weeks)
measure: Change in mean Satisfaction with Sexual Arousal from FSEP-R Q7.
timeFrame: Baseline up to End of Study(8weeks)
measure: 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.
timeFrame: Baseline up to End of Study(8weeks)
measure: Change from Baseline to End of study in the arousal domain from the FSFI Q3 through Q6.
timeFrame: Baseline up to End of Study(8weeks)
measure: Change from Baseline to End of study in the total number of SSEs.
timeFrame: Baseline up to End of Study(8weeks)
measure: Change from baseline in the desire domain from the FSFI Q1 and Q2 using all available double-blind data (visit 4, 5)
timeFrame: Baseline up to End of Study(8weeks)
measure: 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)
timeFrame: Baseline up to End of Study(8weeks)
measure: Change from baseline in the number of SSEs associated with study drug using the entire 8 weeks of the double-blind phase.
timeFrame: Baseline up to End of Study(8weeks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Soo Woong Kim, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Anam Hospital
name: Tak Kim, Dr
role: PRINCIPAL_INVESTIGATOR
References: