Imperial College NHS Healthcare Trust
London, W12 0NN, United Kingdom
Location status: Recruiting
Location contact
Channa Jayasena, MBBS, PhD
CONTACT
Waljit Dhillo, PhD, FRCP
CONTACT
Waljit Dhillo, PhD, FRCP
PRINCIPAL_INVESTIGATOR
NCT Number: NCT02081924
We want to find out what happens to reproductive hormone levels; Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH), testosterone and oestradiol when kisspeptin is administered to people for a period of 8 days each month, using either placebo (saline) or kisspeptin in doses of 0.1, 0.3 or 1.0 nmol/kg/hour.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
London, W12 0NN, United Kingdom
Location status: Recruiting
Channa Jayasena, MBBS, PhD
CONTACT
Waljit Dhillo, PhD, FRCP
CONTACT
Waljit Dhillo, PhD, FRCP
PRINCIPAL_INVESTIGATOR
Participants will be invited to have an initial baseline study to look at the hormone levels at regular intervals over the course of a day (8hours).
Following this, on a different day, volunteers will have an infusion of kisspeptin, which will be administered by a small pump to deliver the hormone into subcutaneous tissue (fatty tissue just below the skin surface). On day 1 of the pump infusion there will be another day of regular blood sampling for 8 hours. After this the kisspeptin pump will continue and the participants will return to the research unit on day 3 for a review and a single blood test. On day 5 the participants will have a review, a blood test and the kisspeptin pump will be changed. Kisspeptin infusion will continue and on Day 8 the participant will return for another 8 hour study. At the end of this the kisspeptin pump will be removed.
The above will be repeated using either placebo (saline) or kisspeptin in doses of 0.1, 0.3 or 1.0 nmol/kg/hour during the early follicular phase of 4 separate menstrual cycles.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive kisspeptin hormone at a dose rate of 0.1nmol/kg/hour via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.
LH, FSH and oestradiol will be measured on day 1 and 8, at 10minute intervals for 8 hours and on Days 3 and 5 they will have a single blood measurement of the same hormones.
Participants will receive placebo (saline) via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.
LH, FSH and oestradiol will be measured on day 1 and 8, at 10minute intervals for 8 hours and on Days 3 and 5 they will have a single blood measurement of the same hormones.
Participants will receive kisspeptin hormone at a dose rate of 0.3 nmol/kg/hour via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.
LH, FSH and oestradiol will be measured on day 1 and 8, at 10minute intervals for 8 hours and on Days 3 and 5 they will have a single blood measurement of the same hormones.
Participants will receive kisspeptin hormone at a dose rate of 1.0 nmol/kg/hour via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.
LH, FSH and oestradiol will be measured on day 1 and 8, at 10minute intervals for 8 hours and on Days 3 and 5 they will have a single blood measurement of the same hormones.
Time frame: 3 months
Luteinising hormone levels will be measured at various time-points to assess the effect of kisspeptin on hypothalamic reproductive function, whilst the participant receives a kisspeptin infusion
Time frame: 3 months
FSH levels will be measured at various time-points to assess the effect of kisspeptin on hypothalamic reproductive function, whilst the participant receives a kisspeptin infusion
Time frame: 3 months
Oestradiol levels will be measured at various time-points to assess the effect of kisspeptin on hypothalamic reproductive function, whilst the participant receives a kisspeptin infusion
Time frame: 3 months
Reproductive hormone levels (LH, FSH, oestradiol) will be measured at various timepoints, whilst the participant receives a kisspeptin infusion. The results of the two groups will then be compared with one another.
Contact information is provided by the study sponsor or research team.
ALi Abbara, PhD MRCP
CONTACT
Debbie A Papadopoulou, BSc MRes
CONTACT
Imperial College London
Other
The Physiological Changes in Reproductive Hormones During Sustained Administration of Kisspeptin in Humans.
Acronym: KisspeptPump
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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