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NCT Number: NCT02081924

Reproductive Hormones During Sustained Administration of Kisspeptin

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kisspeptin 0.1

Other

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

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

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

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.

Primary outcomes

  1. Effect of Kisspeptin on hypothalamic reproductive function - LH levels

    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

Secondary outcomes

  1. Effect of Kisspeptin on hypothalamic reproductive function - FSH levels

    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

  2. Effect of Kisspeptin on hypothalamic reproductive function - Oestradiol levels

    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

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ALi Abbara, PhD MRCP

CONTACT

[email protected]

020 8383 3242

Debbie A Papadopoulou, BSc MRes

CONTACT

[email protected]

020 8383 3242

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

The Physiological Changes in Reproductive Hormones During Sustained Administration of Kisspeptin in Humans.

Acronym: KisspeptPump

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Mar 7, 2014
Registry last updated
Sep 19, 2024

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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