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)

• Sponsor: Kwang Dong Pharmaceutical co., ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04943068
• Collaborator: (none)
• Enrollment: 186
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.7
• Patients Per Site Per Month: 9.4

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Hypoactive Sexual Desire Disorder	Drug: Bremelanotide; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 186 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: May 10, 2021
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bremelanotide Bremelanotide (BMT) subcutaneously (SC) via auto-injector for 8-weeks double-Blind period	Drug: Bremelanotide; Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector.
Placebo Comparator: Placebo Placebo subcutaneously (SC) via auto-injector for 4-weeks single-Blind period and for 8-weeks double-Blind period	Drug: Placebo; Subjects will self-administer a Placebo subcutaneously (SC) via auto-injector.

Outcome Measures

Primary Outcome Measures

1. Change from baseline to End of Study in the desire domain from the FSFI [Baseline up to End of Study(8weeks)]

Secondary Outcome Measures

1. Change from baseline to End of Study in FSDS-DAO (Item 13) [Baseline up to End of Study(8weeks)]

2. Change from Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration [Baseline up to End of Study(8weeks)]

3. Change from Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R [Baseline up to End of Study(8weeks)]

4. Change from Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R [Baseline up to End of Study(8weeks)]

5. Change from Baseline to End of Study in the FSDS-DAO Total Score [Baseline up to End of Study(8weeks)]

6. Change from Baseline to End of study in the total FSFI score based on the 19 questions [Baseline up to End of Study(8weeks)]

   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.

7. Change in mean Level of Sexual Arousal from FSEP-R Q6 [Baseline up to End of Study(8weeks)]

8. Change in mean Satisfaction with Sexual Arousal from FSEP-R Q7. [Baseline up to End of Study(8weeks)]

9. 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. [Baseline up to End of Study(8weeks)]

10. Change from Baseline to End of study in the arousal domain from the FSFI Q3 through Q6. [Baseline up to End of Study(8weeks)]

11. Change from Baseline to End of study in the total number of SSEs. [Baseline up to End of Study(8weeks)]

12. Change from baseline in the desire domain from the FSFI Q1 and Q2 using all available double-blind data (visit 4, 5) [Baseline up to End of Study(8weeks)]

13. 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) [Baseline up to End of Study(8weeks)]

14. Change from baseline in the number of SSEs associated with study drug using the entire 8 weeks of the double-blind phase. [Baseline up to End of Study(8weeks)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

[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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Kwang Dong Pharmaceutical co., ltd.

Investigators

• Principal Investigator: Soo Woong Kim, Dr, Seoul National University Hospital
• Principal Investigator: Tak Kim, Dr, Korea University Anam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kwang Dong Pharmaceutical co., ltd.
• ClinicalTrials.gov Identifier: NCT04943068
• Other Study ID Numbers: KD-BMT-301
• First Posted: Jun 29, 2021
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Kwang Dong Pharmaceutical co., ltd.: KD-BMT-301; Bremelanotide
• Additional relevant MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological

Study Results

No Results Posted as of May 17, 2022