Reproductive disorders Nutritional, Metabolic, Endocrine
Conditions
Interventions
Randomised, placebo-controlled, cross-over study in healthy volunteers (men and women) and patients with common reproductive disorders (including hypothalamic amenorrhoea). Following self-administrati
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers: 1. Aged 18–70 years 2. Non-smokers 3. Free of current or past physical or psychiatric illness 4. Naive to psychoactive substances, prescribed or illicit, for a minimum of 6 months prior to screening. 5. Regular menstrual cycles (women) For patients with common reproductive disorders: 1. Patients diagnosed in accordance with established guidelines (e.g. Endocrine Society guidelines for hypothalamic amenorrhoea)
Exclusion criteria
Exclusion criteria: 1. History of any medical, psychological or other condition, or use of any medications, including over-the-counter products and hormonal therapies, 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. Pregnancy and/or breastfeeding 4. Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study 5. History of hypersensitivity to any of the components administered 6. Treatment with an investigational drug within the preceding 2 months 7. Those who have or intend to donate blood or blood products within three months before or following study completion 8. A history of major haematological, renal, thyroid or hepatic abnormalities or significant cardiovascular disease 9. A history of cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood levels of reproductive hormones (kisspeptin, luteinizing hormone, follicle stimulating hormone, testosterone [men] and oestradiol/progesterone [women]) measured using automated chemiluminescent immunoassays at baseline and every 15 minutes for 4 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety monitoring: heart rate, blood pressure, and the presence of adverse symptoms measured using automated blood pressure monitor every 15 minutes for 4 hours 2. Behavioural parameters of reproductive behaviour assessed using validated psychometric questionnaires (including the Sexual Arousal and Desire Inventory, Positive and Negative Affect Schedule, and State-Trait-Anxiety-Inventory) at baseline and every hour until 4 hours | — |
Countries
England, United Kingdom
Contacts
Public ContactEdouard Mills
Outcome results
None listed