Clinical studies to examine the effects of intranasal kisspeptin delivery on reproductive hormones
- Conditions
- Reproductive disordersNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN10095215
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 18
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)
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method