Postmenopausal women with distressing low sexual desire caused by Hypoactive Sexual Desire Disorder, according to the International Classification of Diseases 11th Revision (ICD-11), including categorisation as both acquired (versus lifelong) and generalised (versus situational). Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants will attend two study visits each for subcutaneous administration of kisspeptin (12.8 nmol/kg) and placebo (using 0.9% saline
identical in volume and appearance to kisspeptin). Study visits will be scheduled at least 1 month apart.
The study will explore changes in:
1. Brain activity, as determined by functional MRI (fMRI)
Sponsors
Imperial College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women =40 years old 2. Postmenopausal (i.e., no spontaneous period for > 1 year) caused by natural menopause 3. Heterosexual 4. Right-hand dominant 5. Body mass index (BMI) 18-30 kg/m2 6. Currently in a relationship and the relationship has been stable for at least 6 months before screening 7. The participant’s partner must be sexually functional without erectile dysfunction or premature ejaculation 8. In the subject’s opinion, previously experienced “normal sexual function,” defined as a normal level of desire at some point in the past 9. Hypoactive Sexual Desire Disorder according to the International Classification of Diseases 11th Revision (ICD-11), including categorisation as both acquired (versus lifelong) and generalised (versus situational) 10. All of the following at Screening: 10.1. Patient Health Questionnaire (PHQ-9) total score is 18 11. Receiving systemic Hormone Replacement Therapy (HRT) and be on a stable dose for at least 6-months prior to screening with the intention of maintaining that regimen during the study 12. Prior experience in viewing sexually explicit material 13. Participants must be able to provide full informed consent. We will make every reasonable effort to accommodate a participant who does not speak English as their first language, such as using an interpreter. However, where there is doubt as to whether the potential participant can fully understand the study, we will not be able to include them as their consent would not be fully informed and there may be difficulty in performing the tasks required for the study which would impact the data collected and hence the robustness of the study
Exclusion criteria
Exclusion criteria: 1. History of any medical, psychological, or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the participant. 2. Medical or psychological conditions that would impair their ability to participate reliably in the study or give informed consent. 3. History of major haematological, renal, thyroid, or hepatic abnormalities or significant cardiovascular disease. 4. History of significant pelvic surgery (including hysterectomy). 5. History of cancer. 6. History of unresolved sexual trauma/abuse 7. Diagnosis of another sexual disorder. 8. Receiving any other treatment for HSDD (beyond HRT) at the time of screening, such as testosterone therapy. 9. Any implanted material in the body that would preclude magnetic resonance imaging (MRI) for safety reasons. 10. Inability to tolerate MRI scanning (e.g., claustrophobia or inability to lie flat). 11. Impaired vision which would preclude the ability to view erotic material. 12. Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study. 13. History of hypersensitivity to any of the components administered. 14. Participation in any research study within the preceding 30 days (or 2 months if an investigational drug was administered). 15. Those who have or intend to donate blood or blood products within three months before or following study completion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in brain activity measured using fMRI blood oxygen level-dependent (BOLD) activity in response to visual erotic stimuli at the study visits when participants are administered kisspeptin compared to placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at study visits when participants are administered kisspeptin compared to placebo: 1. Non-task brain activity measured using fMRI resting brain activity 2. Sexual desire and arousal measured using validated psychometric questionnaires, such as the Sexual Arousal and Desire Inventory (SADI) and a behavioural potentiometer [i.e., a hand-held analogue device enabling continuous ratings] in response to visual erotic stimuli 3. General mood, anxiety, and non-sexual attention measured using validated psychometric questionnaires in response to visual erotic stimuli 4. Changes in psychometric measures of sexual desire and arousal measured using validated psychometric questionnaires such as the SADI 5. Physiological sexual arousal measured using thermography in response to visual erotic stimuli 6. Physiological sexual arousal measured using thermography [not in response to visual erotic stimuli, i.e., during non-task brain scan] 7. Blood parameters such as plasma kisspeptin and serum levels of FSH, LH, oestradiol, progesterone testosterone, and cortisol 8. Correlation analyses between fMRI brain activity in response to visual erotic stimuli and change in physiological sexual arousal measured using thermography 9. Correlation analyses between fMRI brain activity in response to visual erotic stimuli and changes in psychometric measures of sexual arousal and general mood/anxiety/non-sexual attention measured using validated psychometric questionnaires and a behavioural potentiometer 10. Correlation analyses between physiological sexual arousal measured using thermography and psychometric measures of sexual desire, arousal, and general mood/anxiety/non-sexual attention measured using validated psychometric questionnaires 11. Correlation analyses between hormonal data (plasma kisspeptin and serum levels of FSH, LH, oestradiol, progesterone, testosterone, and cortisol) and the aforementioned neuroimaging, physiological an | — |
Countries
England, United Kingdom
Contacts
Public ContactEdouard Mills
Outcome results
None listed