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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)

Primary Purpose

Hypoactive Sexual Desire Disorder

Status

Recruiting

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Bremelanotide

Placebo

About this trial

This is an interventional treatment trial for Hypoactive Sexual Desire Disorder focused on measuring KD-BMT-301, Bremelanotide

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

[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

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bremelanotide

Placebo

Arm Description

Bremelanotide (BMT) subcutaneously (SC) via auto-injector for 8-weeks double-Blind period

Placebo subcutaneously (SC) via auto-injector for 4-weeks single-Blind period and for 8-weeks double-Blind period

Outcomes

Primary Outcome Measures

Change from baseline to End of Study in the desire domain from the FSFI

Secondary Outcome Measures

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

The FSFI total score is on a scale ranging from 2 to 36. Increasing scores on this scale represent an increase in sexual desire and is a positive outcome.

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.

Full Information

NCT ID

NCT04943068

First Posted

June 10, 2021

Last Updated

May 15, 2022

Sponsor

Kwang Dong Pharmaceutical co., ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04943068

Brief 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)

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 10, 2021 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kwang Dong Pharmaceutical co., ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoactive Sexual Desire Disorder

Keywords

KD-BMT-301, Bremelanotide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bremelanotide

Arm Type

Experimental

Arm Description

Bremelanotide (BMT) subcutaneously (SC) via auto-injector for 8-weeks double-Blind period

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo subcutaneously (SC) via auto-injector for 4-weeks single-Blind period and for 8-weeks double-Blind period

Intervention Type

Drug

Intervention Name(s)

Bremelanotide

Intervention Description

Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Subjects will self-administer a Placebo subcutaneously (SC) via auto-injector.

Primary Outcome Measure Information:

Title

Change from baseline to End of Study in the desire domain from the FSFI

Time Frame