Health TrialsbyHealthPanel

Reproductive Hormones During Sustained Administration of Kisspeptin

ConditionsFertility DisordersHypothalamic Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorImperial College London

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18-60 years old

Ability to give informed consent

Secondary hypogonadism (or healthy participant)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Kisspeptin 0.1

    Other intervention

    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.

  • Saline

    Other intervention

    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.

  • Kisspeptin 0.3

    Other intervention

    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.

  • Kisspeptin 1.0

    Other intervention

    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.

Treatment groups

76 Participants
are divided into 4 treatment groups
Group A: Kisspeptin 0.1Active comparator 1 intervention
Group B: SalinePlacebo comparator 1 intervention
Group C: Kisspeptin 0.3Active comparator 1 intervention
Group D: Kisspeptin 1.0Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Effect of Kisspeptin on hypothalamic reproductive function - LH levels

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

Secondary outcomes

1

Effect of Kisspeptin on hypothalamic reproductive function - FSH levels

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
2

Effect of Kisspeptin on hypothalamic reproductive function - Oestradiol levels

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
3

Do participants with normal fertility respond differently to sustained administration of kisspeptin, compared to participants with reduced fertility?

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.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College London

Lead sponsor

Source ClinicalTrials.gov
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