Reproductive Hormones During Sustained Administration of Kisspeptin
The Physiological Changes in Reproductive Hormones During Sustained Administration of Kisspeptin in Humans.
Imperial College London
76 participants
Apr 2, 2014
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- Aged 18-60 years old
- Ability to give informed consent
- Secondary hypogonadism (or healthy participant)
Exclusion Criteria12
- anaemia
- medical problems such as severe heart, kidney or liver disease
- blood donation in the last three months or intention to donate blood within 3 months of the end of the study
- needle phobia
- Poor venous access
- Active psychiatric illness
- Severe allergies
- Impaired ability to provide full consent to take part in the study
- Current alcohol or illicit drug dependence
- Current pregnancy or breast feeding
- Plans to conceive within 3 months of starting the study (barrier contraception must be used during and for 3 months after the end of the study)
- Arthritis or any impairment of hand coordination which would preclude using a hormone pump
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT02081924