Hypoactive Sexual Desire DisorderPhase 4NCT04179734
Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder
A Phase 4 study testing Bremelanotide in people with Hypoactive Sexual Desire Disorder, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
A randomised, double-blind, placebo-controlled, two-way crossover physiological study. Designed to evaluate the effects of melanocortin-4 receptor (MC4R) activation on brain activity patterns and behavioural psychometric measures of sexual arousal during visual erotic stimuli in approximately 40 right-handed… Read more about this study
- Who is it for?
- Ages 18 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
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Oct 2019to 6 Oct 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heterosexual premenopausal females ≥ 18 years of age with normal menstrual cycles ≤ 35 days.
- Right hand dominant.
- Body mass index (BMI) 18-35kg/m2.
- Currently in a relationship with a male partner and the relationship has been stable for at least 6 months before screening.
- Male sexual partner classified as "not impotent" on the Massachusetts Male Aging Study (MMAS) single-question assessment of erectile dysfunction.
- In the subject's opinion, previously experienced "normal sexual function," defined as a normal level of desire at some point in the past, for a period of at least 2 years.
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- For all subjects of childbearing potential who are sexually active, agree to routinely use adequate non-hormonal contraception from randomisation throughout the duration of the study and for 30 days after.
- For at least 6 months before Screening, met the diagnostic criteria for HSDD according to the Diagnostic Screening Guide for HSDD, including categorisation of the sexual dysfunction as both acquired (versus lifelong) and generalised (versus situational).
- All of the following at Screening:
- Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001) total score is <10.
- PHQ-9 score for Question 9 is 0.
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- Either Female Sexual Function Index (FSFI) total score ≤26 if diagnosed with HSDD (with or without symptoms of decreased arousal) or subjects diagnosed with HSDD only (without symptoms of decreased arousal), FSFI desire domain score of ≤5 (regardless of total FSFI score).
- Female Sexual Distress Scale - Desire/Arousal/Orgasm (FSDS-DAO) total score is >18.
- Capable of understanding and complying with the protocol requirements and available for the duration of the study.
- Subjects must have prior experience in viewing sexually explicit material.
Who cannot join
- Cardiovascular disease
- Current diagnosis of uncontrolled hypertension defined as:
- Two sequential assessments (seated, approximately 4 minutes apart and no more than 15 minutes apart) with readings above 140 mmHg systolic BP or 90 mmHg diastolic BP, and upon repeat at least 24 hours later.
- Treatment for hypertension that has been changed at least once in the 4 weeks prior to Screening.
- Any other medical condition that is unstable or uncontrolled despite current therapy.
- Previously received Bremelanotide.
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- A history of unresolved sexual trauma or abuse.
- Female subjects who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test, or are not willing to use effective contraceptive precautions during the study.
- Participated in any research study within the preceding 30 days of screening.
- Any FSD other than acquired HSDD with or without decreased arousal (e.g. lifelong anorgasmia, sexual pain disorder, sexual aversion disorder, primary female sexual arousal disorder).
- FSD caused by untreated endocrine disease (e.g. hypopituitarism, hypothyroidism, diabetes mellitus).
- Acute or chronic hepatitis.
- In the Investigator's opinion, any urologic or gynecologic condition, such as condyloma, uterine fibroids, vulvar or vaginal lesions, vulvodynia, vaginismus, or pelvic pain that may contribute to impaired sexual activity and function or be a cause of the FSD or that may interfere with the subject's ability to comply with study procedures.
- Receiving any treatment for HSDD (e.g. psychotherapy, physical therapy) at the time of Screening.
- Has used any of the following types of medications, which are prohibited during the study:
- Implanted or injected testosterone product within 6 months of Screening.
- Within 3 months of Screening:
- Neuroleptics (e.g. risperidone)
- Lithium (e.g. lithium carbonate)
- Antidepressants (e.g. amitriptyline, fluoxetine, bupropion)
- Mood stabilisers (e.g. valproate)
- Benzodiazepines (e.g. lorazepam, diazepam)
- Cognitive enhancers or stimulants (e.g. donepezil or Adderall®)
- Centrally-acting antihypertensives (e.g. clonidine)
- Any other prescription, non-prescription, hormonal, herbal, or nutritional medication or supplement that the investigators believe would confound the results of the study (e.g. St. John's wort, black cohosh, dehydroepiandrosterone, dehydroepiandrosterone sulfate)
- γ-Aminobutyric acid agonists (e.g. Ambien® [zolpidem], Lunesta® [eszopiclone]) c. Topical or systemic androgen therapy within 30 days of Screening. d. Subject is unwilling or unable to refrain from using the aforementioned products for the duration of the study.
- Mental health history that includes any of the following:
- Psychosis, bipolar disorder, depression, and/or alcohol/substance abuse; depression or alcohol/substance abuse that resolved >1 year prior to Screening/Visit 1 will not be exclusionary.
- Prior suicide attempt or increased suicidality as indicated by a score greater than zero on Questions 1-5 inclusive (interpreted increased risk) and/or Question 20 (interpreted history of suicide) of the Beck Scale for Suicidal Ideation (BSS),
- Any abnormality in vision that would impair viewing images.
- Any contraindication to MRI or otherwise unable to undergo an MRI (e.g. pacemaker, recent wound clips, severe claustrophobia, unable to lay flat).
- Any other condition or subject responsibility that in the Investigator's opinion may interfere with a subject's ability to give informed consent or adhere to the protocol or has the potential to interfere with the studied endpoints or serves as a contraindication to the subject's participation in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: Physiological Study to Determine the Role of the Melanocortin-4 Receptor in Brain Activity in Women With Hypoactive Sexual Desire Disorder
A randomised, double-blind, placebo-controlled, two-way crossover physiological study. Designed to evaluate the effects of melanocortin-4 receptor (MC4R) activation on brain activity patterns and behavioural psychometric measures of sexual arousal during visual erotic stimuli in approximately 40 right-handed, heterosexual, premenopausal women aged 18 years and over with Hypoactive Sexual Desire Disorder (HSDD) for at least a 6 month duration.
Read the detailed description
The investigators aim to recruit approximately 40 women to allow for subject and technical drop-out, aiming for a minimum of 30 women in the final study who complete the full protocol successfully. The investigators will collaborate with the Sexual Medicine clinic to identify potential participants, as well as advertise via print (including local and regional newspapers, transport network), radio and online advertisements. Additionally, the investigators will liaise with the local Clinical Research Network (CRN) to contact potentially eligible patients via their General Practitioner (GP) surgery (via letter or text message). Potential participants who contact us via advertisements will initially be electronically sent a participant information sheet and self-report questionnaire, to be returned via email. If, following this, they are happy to take part and no obvious exclusion criteria are detected, they will be screened via telephone using a questionnaire. If eligible, they will be invited for a formal screening interview, where further questions regarding the study will be answered. After obtaining consent, a full medical and sexual history will be taken as well as a review of the diagnosis of assessment, an ECG, urinalysis to exclude pregnancy, clinical laboratory testing and completion of psychiatric and psychosexual questionnaires.
Eligible participants will then enter the Intervention phase. Participants will be randomised (1:1) to one of two intervention sequences: a single dose of Bremelanotide or matching placebo, administered subcutaneously. All participants will attend for two study visits each, during which they will undergo a functional magnetic resonance imaging (fMRI) scan while receiving either Bremelanotide or placebo. During the scan, participants will be presented with visual erotic stimuli in order to activate the brain, so that Bremelanotide's modulation of the melanocortin system can be measured. The participants will also be asked to use a behavioural potentiometer whilst in the scanner to rate their degree of sexual arousal. The crossover design, which allows participants to serve as their own control, will minimise inter-participant variability. Participants will also be sent a short questionnaire 24-hours after the study to assess the perceived duration of effect of Bremelanotide.
The MRI data will be processed and analysed using current best practice methods, which will include (but may not be limited to) application of the General Linear Model (GLM) for neuroimaging data. Robust methods of correcting for multiple comparisons (e.g. permutation testing) will be used for statistical analysis and thresholding of the statistical brain images. Brain activation patterns will be presented by intervention and analysed by whole-brain and region of interest (including amygdala, thalamus, posterior cingulate cortex and entorhinal region. Correlations will be explored between brain activation and behavioural data, corrected for visit order as appropriate (including Pearson and Partial Correlation testing).
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- Bremelanotide, Placebo
- Keywords
- Hypoactive Sexual Desire Disorder, Bremelanotide, Functional MRI, Melanocortin-4 receptor
- 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
Melanocortin-4 receptor agonist subcutaneous injection.
PlaceboDrug
Placebo subcutaenous injection.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Bremelanotide 1.75 mg - prefilled subcutaneous autoinjector containing 1.75 mg Bremelanotide in a 0.3 mL solution volume. Receives: Drug: Bremelanotide; Drug: Placebo |
| Placebo | Placebo comparator | 1.75 mg equivalent - prefilled subcutaneous autoinjector containing Bremelanotide formulation without the active ingredient in a 0.3 mL solution volume. Receives: Drug: Bremelanotide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Blood Oxygen Level Dependent (BOLD) Signal Change on Functional MRI
Blood Oxygen Level Dependent (BOLD) imaging was used to detect activation clusters within the brain. Units of measure were standardised regression coefficients derived from the regression analysis that were used to fit the analysis model to the time-series data (BOLD signal change). Higher BOLD signal change values indicate increased activation in particular areas of the brain in response to the intervention (Bremelanotide or Placebo).
Measured: Baseline and 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start7 Oct 2019
- Primary completion6 Oct 2020
- Study completion6 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Waljit S Dhillo, MBBS PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179734
- Sponsor's protocol ID
- 262886
- Status last verified
- Jul 2024
- First submitted
- 1 Nov 2019
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arnow BA, Millheiser L, Garrett A, Lake Polan M, Glover GH, Hill KR, Lightbody A, Watson C, Banner L, Smart T, Buchanan T, Desmond JE. Women with hypoactive sexual desire disorder compared to normal females: a functional magnetic resonance imaging study. Neuroscience. 2009 Jan 23;158(2):484-502. doi: 10.1016/j.neuroscience.2008.09.044. Epub 2008 Oct 2.
PubMed 18976696Bianchi-Demicheli F, Cojan Y, Waber L, Recordon N, Vuilleumier P, Ortigue S. Neural bases of hypoactive sexual desire disorder in women: an event-related FMRI study. J Sex Med. 2011 Sep;8(9):2546-59. doi: 10.1111/j.1743-6109.2011.02376.x. Epub 2011 Jun 30.
PubMed 21718449Pfaus JG, Shadiack A, Van Soest T, Tse M, Molinoff P. Selective facilitation of sexual solicitation in the female rat by a melanocortin receptor agonist. Proc Natl Acad Sci U S A. 2004 Jul 6;101(27):10201-4. doi: 10.1073/pnas.0400491101. Epub 2004 Jun 28.
PubMed 15226502Shifren JL, Monz BU, Russo PA, Segreti A, Johannes CB. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol. 2008 Nov;112(5):970-8. doi: 10.1097/AOG.0b013e3181898cdb.
PubMed 18978095Murphy K, Garavan H. An empirical investigation into the number of subjects required for an event-related fMRI study. Neuroimage. 2004 Jun;22(2):879-85. doi: 10.1016/j.neuroimage.2004.02.005.
PubMed 15193618Wikberg JE, Muceniece R, Mandrika I, Prusis P, Lindblom J, Post C, Skottner A. New aspects on the melanocortins and their receptors. Pharmacol Res. 2000 Nov;42(5):393-420. doi: 10.1006/phrs.2000.0725.
PubMed 11023702Woodard TL, Nowak NT, Balon R, Tancer M, Diamond MP. Brain activation patterns in women with acquired hypoactive sexual desire disorder and women with normal sexual function: a cross-sectional pilot study. Fertil Steril. 2013 Oct;100(4):1068-76. doi: 10.1016/j.fertnstert.2013.05.041. Epub 2013 Jul 2.
PubMed 23830149Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019 Nov;134(5):899-908. doi: 10.1097/AOG.0000000000003500.
PubMed 31599840Thurston L, Hunjan T, Mills EG, Wall MB, Ertl N, Phylactou M, Muzi B, Patel B, Alexander EC, Suladze S, Modi M, Eng PC, Bassett PA, Abbara A, Goldmeier D, Comninos AN, Dhillo WS. Melanocortin 4 receptor agonism enhances sexual brain processing in women with hypoactive sexual desire disorder. J Clin Invest. 2022 Oct 3;132(19):e152341. doi: 10.1172/JCI152341.
PubMed 36189794
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Study to Determine the Role of the Melanocortin-4 Receptor in Brain Activity in Women With Hypoactive Sexual Desire Disorder
- ClinicalTrials.gov ID
- NCT04179734
- Acronym / sponsor ID
- 262886
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- Hypoactive Sexual Desire Disorder, Bremelanotide, Functional MRI, Melanocortin-4 receptor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- AMAG Pharmaceuticals, Inc.
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 6 Oct 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomised, double-blind, placebo-controlled, two-way crossover physiological study. Designed to evaluate the effects of melanocortin-4 receptor (MC4R) activation on brain activity patterns and behavioural psychometric measures of sexual arousal during visual erotic stimuli in approximately 40 right-handed, heterosexual, premenopausal women aged 18 years and over with Hypoactive Sexual Desire Disorder (HSDD) for at least a 6 month duration.
Detailed description
The investigators aim to recruit approximately 40 women to allow for subject and technical drop-out, aiming for a minimum of 30 women in the final study who complete the full protocol successfully. The investigators will collaborate with the Sexual Medicine clinic to identify potential participants, as well as advertise via print (including local and regional newspapers, transport network), radio and online advertisements. Additionally, the investigators will liaise with the local Clinical Research Network (CRN) to contact potentially eligible patients via their General Practitioner (GP) surgery (via letter or text message). Potential participants who contact us via advertisements will initially be electronically sent a participant information sheet and self-report questionnaire, to be returned via email. If, following this, they are happy to take part and no obvious exclusion criteria are detected, they will be screened via telephone using a questionnaire. If eligible, they will be invited for a formal screening interview, where further questions regarding the study will be answered. After obtaining consent, a full medical and sexual history will be taken as well as a review of the diagnosis of assessment, an ECG, urinalysis to exclude pregnancy, clinical laboratory testing and completion of psychiatric and psychosexual questionnaires.
Eligible participants will then enter the Intervention phase. Participants will be randomised (1:1) to one of two intervention sequences: a single dose of Bremelanotide or matching placebo, administered subcutaneously. All participants will attend for two study visits each, during which they will undergo a functional magnetic resonance imaging (fMRI) scan while receiving either Bremelanotide or placebo. During the scan, participants will be presented with visual erotic stimuli in order to activate the brain, so that Bremelanotide's modulation of the melanocortin system can be measured. The participants will also be asked to use a behavioural potentiometer whilst in the scanner to rate their degree of sexual arousal. The crossover design, which allows participants to serve as their own control, will minimise inter-participant variability. Participants will also be sent a short questionnaire 24-hours after the study to assess the perceived duration of effect of Bremelanotide.
The MRI data will be processed and analysed using current best practice methods, which will include (but may not be limited to) application of the General Linear Model (GLM) for neuroimaging data. Robust methods of correcting for multiple comparisons (e.g. permutation testing) will be used for statistical analysis and thresholding of the statistical brain images. Brain activation patterns will be presented by intervention and analysed by whole-brain and region of interest (including amygdala, thalamus, posterior cingulate cortex and entorhinal region. Correlations will be explored between brain activation and behavioural data, corrected for visit order as appropriate (including Pearson and Partial Correlation testing).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Bremelanotide, Drug: PlaceboBremelanotide 1.75 mg - prefilled subcutaneous autoinjector containing 1.75 mg Bremelanotide in a 0.3 mL solution volume. |
| Placebo | Placebo comparator | Drug: Bremelanotide, Drug: Placebo1.75 mg equivalent - prefilled subcutaneous autoinjector containing Bremelanotide formulation without the active ingredient in a 0.3 mL solution volume. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Heterosexual premenopausal females ≥ 18 years of age with normal menstrual cycles ≤ 35 days.
- Right hand dominant.
- Body mass index (BMI) 18-35kg/m2.
- Currently in a relationship with a male partner and the relationship has been stable for at least 6 months before screening.
- Male sexual partner classified as "not impotent" on the Massachusetts Male Aging Study (MMAS) single-question assessment of erectile dysfunction.
Key exclusion criteria (32 listed)
- Cardiovascular disease
- Current diagnosis of uncontrolled hypertension defined as:
- Any other medical condition that is unstable or uncontrolled despite current therapy.
- Previously received Bremelanotide.
- A history of unresolved sexual trauma or abuse.
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 |
|---|---|---|
| BremelanotideMelanocortin-4 receptor agonist subcutaneous injection. | Drug | Intervention, Placebo |
| PlaceboPlacebo subcutaenous injection. | Drug | Intervention, Placebo |
Primary outcome
Changes in Blood Oxygen Level Dependent (BOLD) Signal Change on Functional MRI
Time frame: Baseline and 15 minutes
Blood Oxygen Level Dependent (BOLD) imaging was used to detect activation clusters within the brain. Units of measure were standardised regression coefficients derived from the regression analysis that were used to fit the analysis model to the time-series data (BOLD signal change). Higher BOLD signal change values indicate increased activation in particular areas of the brain in response to the intervention (Bremelanotide or Placebo).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18976696Arnow BA, Millheiser L, Garrett A, Lake Polan M, Glover GH, Hill KR, Lightbody A, Watson C, Banner L, Smart T, Buchanan T, Desmond JE. Women with hypoactive sexual desire disorder compared to normal females: a functional magnetic resonance imaging study. Neuroscience. 2009 Jan 23;158(2):484-502. doi: 10.1016/j.neuroscience.2008.09.044. Epub 2008 Oct 2.
- Background: PubMed 21718449Bianchi-Demicheli F, Cojan Y, Waber L, Recordon N, Vuilleumier P, Ortigue S. Neural bases of hypoactive sexual desire disorder in women: an event-related FMRI study. J Sex Med. 2011 Sep;8(9):2546-59. doi: 10.1111/j.1743-6109.2011.02376.x. Epub 2011 Jun 30.
- Background: PubMed 15226502Pfaus JG, Shadiack A, Van Soest T, Tse M, Molinoff P. Selective facilitation of sexual solicitation in the female rat by a melanocortin receptor agonist. Proc Natl Acad Sci U S A. 2004 Jul 6;101(27):10201-4. doi: 10.1073/pnas.0400491101. Epub 2004 Jun 28.
- Background: PubMed 18978095Shifren JL, Monz BU, Russo PA, Segreti A, Johannes CB. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol. 2008 Nov;112(5):970-8. doi: 10.1097/AOG.0b013e3181898cdb.
- Background: PubMed 15193618Murphy K, Garavan H. An empirical investigation into the number of subjects required for an event-related fMRI study. Neuroimage. 2004 Jun;22(2):879-85. doi: 10.1016/j.neuroimage.2004.02.005.
- Background: PubMed 11023702Wikberg JE, Muceniece R, Mandrika I, Prusis P, Lindblom J, Post C, Skottner A. New aspects on the melanocortins and their receptors. Pharmacol Res. 2000 Nov;42(5):393-420. doi: 10.1006/phrs.2000.0725.
- Background: PubMed 23830149Woodard TL, Nowak NT, Balon R, Tancer M, Diamond MP. Brain activation patterns in women with acquired hypoactive sexual desire disorder and women with normal sexual function: a cross-sectional pilot study. Fertil Steril. 2013 Oct;100(4):1068-76. doi: 10.1016/j.fertnstert.2013.05.041. Epub 2013 Jul 2.
- Background: PubMed 31599840Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019 Nov;134(5):899-908. doi: 10.1097/AOG.0000000000003500.
- Results publication: PubMed 36189794Thurston L, Hunjan T, Mills EG, Wall MB, Ertl N, Phylactou M, Muzi B, Patel B, Alexander EC, Suladze S, Modi M, Eng PC, Bassett PA, Abbara A, Goldmeier D, Comninos AN, Dhillo WS. Melanocortin 4 receptor agonism enhances sexual brain processing in women with hypoactive sexual desire disorder. J Clin Invest. 2022 Oct 3;132(19):e152341. doi: 10.1172/JCI152341.
- Individual participant dataSharing planned: No
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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.
Waljit S Dhillo, MBBS PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bremelanotide in people with Hypoactive Sexual Desire Disorder, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 32 exclusion criteria. 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 9 Aug 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 United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Blood Oxygen Level Dependent (BOLD) Signal Change on Functional MRI (time frame: Baseline and 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04179734, which also lists 9 linked publications.
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 9 Aug 2024.