Reproductive Hormones During Sustained Administration of Kisspeptin

Launched by IMPERIAL COLLEGE LONDON · Mar 5, 2014

Keywords

ClinConnect Summary

This clinical trial is studying how reproductive hormone levels change when a substance called kisspeptin is given to people over a period of 8 days each month. The trial will look at important hormones like Luteinising Hormone (LH), Follicle Stimulating Hormone (FSH), testosterone, and oestradiol. Participants will receive either a placebo (a harmless saline solution) or different doses of kisspeptin to see how it affects their hormone levels. The trial is currently recruiting participants aged 18 to 60 years who have secondary hypogonadism (a condition affecting hormone production) or who are healthy.

To be eligible for this study, participants should be in good health, able to provide informed consent, and not have certain medical issues like severe heart or kidney disease. They should also not be pregnant or breastfeeding, and must use barrier contraception if they plan to conceive within three months after the study. Participants can expect to receive the treatment and have their hormone levels monitored throughout the trial, helping researchers learn more about the effects of kisspeptin on fertility disorders and hormone function.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Aged 18-60 years old
• • Ability to give informed consent
• • Secondary hypogonadism (or healthy participant)
• Exclusion criteria:
• • 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