Hypoactive Sexual Desire DisorderPhase 3NCT04943068
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)
A Phase 3 study testing Bremelanotide in people with Hypoactive Sexual Desire Disorder, run by Kwang Dong Pharmaceutical co., ltd. at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disorder
- What is being tested?
- Bremelanotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 193 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2021to 16 May 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
[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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- Bremelanotide, Placebo
- Keywords
- KD-BMT-301, Bremelanotide
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BremelanotideDrug
Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector.
PlaceboDrug
Subjects will self-administer a Placebo subcutaneously (SC) via auto-injector.
| Study group | Role | What they receive |
|---|---|---|
| Bremelanotide | Experimental | Bremelanotide (BMT) subcutaneously (SC) via auto-injector for 8-weeks double-Blind period Receives: Drug: Bremelanotide |
| Placebo | Placebo comparator | Placebo subcutaneously (SC) via auto-injector for 4-weeks single-Blind period and for 8-weeks double-Blind period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to End of Study in the desire domain from the FSFI
Measured: Baseline up to End of Study(8weeks)
Secondary outcomes (14)
Change from baseline to End of Study in FSDS-DAO (Item 13)
Measured: Baseline up to End of Study(8weeks)
Change from Baseline to End of Study in the Number of Satisfying Sexual Events (SSEs) Associated With Study Drug Administration
Measured: Baseline up to End of Study(8weeks)
Change from Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R
Measured: Baseline up to End of Study(8weeks)
Change from Baseline to End of Study in Mean Satisfaction With Desire Score (Q4) From FSEP-R
Measured: Baseline up to End of Study(8weeks)
Change from Baseline to End of Study in the FSDS-DAO Total Score
Measured: Baseline up to End of Study(8weeks)
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.
Measured: Baseline up to End of Study(8weeks)
Change in mean Level of Sexual Arousal from FSEP-R Q6
Measured: Baseline up to End of Study(8weeks)
Change in mean Satisfaction with Sexual Arousal from FSEP-R Q7.
Measured: Baseline up to End of Study(8weeks)
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.
Measured: Baseline up to End of Study(8weeks)
Change from Baseline to End of study in the arousal domain from the FSFI Q3 through Q6.
Measured: Baseline up to End of Study(8weeks)
Change from Baseline to End of study in the total number of SSEs.
Measured: Baseline up to End of Study(8weeks)
Change from baseline in the desire domain from the FSFI Q1 and Q2 using all available double-blind data (visit 4, 5)
Measured: Baseline up to End of Study(8weeks)
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)
Measured: Baseline up to End of Study(8weeks)
Change from baseline in the number of SSEs associated with study drug using the entire 8 weeks of the double-blind phase.
Measured: Baseline up to End of Study(8weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start10 May 2021
- Primary completion16 May 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoactive Sexual Desire DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwang Dong Pharmaceutical co., ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Soo Woong Kim, Dr, Principal investigator, Seoul National University HospitalTak Kim, Dr, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943068
- Sponsor's protocol ID
- KD-BMT-301
- Status last verified
- Nov 2024
- First submitted
- 10 Jun 2021
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04943068
- Acronym / sponsor ID
- KD-BMT-301
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- KD-BMT-301, Bremelanotide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Kwang Dong Pharmaceutical co., ltd.Industry (pharma, biotech, devices)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bremelanotide | Experimental | Drug: BremelanotideBremelanotide (BMT) subcutaneously (SC) via auto-injector for 8-weeks double-Blind period |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo subcutaneously (SC) via auto-injector for 4-weeks single-Blind period and for 8-weeks double-Blind period |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BremelanotideSubjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector. | Drug | Bremelanotide |
| PlaceboSubjects will self-administer a Placebo subcutaneously (SC) via auto-injector. | Drug | Placebo |
Primary outcome
Change from baseline to End of Study in the desire domain from the FSFI
Time frame: Baseline up to End of Study(8weeks)
14 secondary outcomes
Change from baseline to End of Study in FSDS-DAO (Item 13)
Time frame: Baseline up to End of Study(8weeks)
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)
Change from Baseline to End of Study in Mean Desire Score (Q3) From FSEP-R
Time frame: Baseline up to End of Study(8weeks)
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)
Change from Baseline to End of Study in the FSDS-DAO Total Score
Time frame: Baseline up to End of Study(8weeks)
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)
Change in mean Level of Sexual Arousal from FSEP-R Q6
Time frame: Baseline up to End of Study(8weeks)
Change in mean Satisfaction with Sexual Arousal from FSEP-R Q7.
Time frame: Baseline up to End of Study(8weeks)
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)
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)
Change from Baseline to End of study in the total number of SSEs.
Time frame: Baseline up to End of Study(8weeks)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
Related trials for Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 2
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
Hypoactive Sexual Desire Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soo Woong Kim, Dr principal investigator
Seoul National University Hospital
Tak Kim, Dr principal investigator
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bremelanotide in people with Hypoactive Sexual Desire Disorder, run by Kwang Dong Pharmaceutical co., ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to End of Study in the desire domain from the FSFI (time frame: Baseline up to End of Study(8weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.