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Completed

NCT Number: 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)

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).

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Key information

Conditions

Hypoactive Sexual Desire Disorder Mental Disorders Sexual Dysfunctions, Psychological

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

[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

Treatment and study plan

Bremelanotide

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: Baseline up to End of Study(8weeks)

Secondary outcomes

  1. Change from baseline to End of Study in FSDS-DAO (Item 13)

    Time frame: 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

    Time frame: Baseline up to End of Study(8weeks)

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

    Time frame: 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

    Time frame: Baseline up to End of Study(8weeks)

  5. Change from Baseline to End of Study in the FSDS-DAO Total Score

    Time frame: 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

    Time frame: 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

    Time frame: Baseline up to End of Study(8weeks)

  8. Change in mean Satisfaction with Sexual Arousal from FSEP-R Q7.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline up to End of Study(8weeks)

  11. Change from Baseline to End of study in the total number of SSEs.

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

    Time frame: Baseline up to End of Study(8weeks)

Sponsors and collaborators

Lead sponsor

Kwang Dong Pharmaceutical co., ltd.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 29, 2021
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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