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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kisspeptin 0.1 | Active Comparator | 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. |
|
| Saline | Placebo Comparator | Participants will receive placebo (saline) via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle. |
|
| Kisspeptin 0.3 | Active Comparator | Participants will receive kisspeptin hormone at a dose rate of 0.3nmol/kg/hour via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle. |
|
| Kisspeptin 1.0 | Active Comparator | Participants will receive kisspeptin hormone at a dose rate of 1.0nmol/kg/hour via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
| Effect of Kisspeptin on hypothalamic reproductive function - Oestradiol levels |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ALi Abbara, PhD MRCP | Contact | 020 8383 3242 | ali.abbara@imperial.ac.uk | |
| Debbie A Papadopoulou, BSc MRes | Contact | 020 8383 3242 | d.papadopoulou@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Waljit Dhillo, PhD, FRCP | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College NHS Healthcare Trust | Recruiting | London | W12 0NN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16174713 | Background | Dhillo WS, Chaudhri OB, Patterson M, Thompson EL, Murphy KG, Badman MK, McGowan BM, Amber V, Patel S, Ghatei MA, Bloom SR. Kisspeptin-54 stimulates the hypothalamic-pituitary gonadal axis in human males. J Clin Endocrinol Metab. 2005 Dec;90(12):6609-15. doi: 10.1210/jc.2005-1468. Epub 2005 Sep 20. | |
| 17635940 | Background |
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| ID | Term |
|---|---|
| D007027 | Hypothalamic Diseases |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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This is a prospective, single-blinded placebo-controlled study. Women will receive an 8-h SC infusion of kisspeptin-54 0·1, 0·3 or 1·0 nmol/kg/h or saline in the early follicular phase of 4 separate menstrual cycles. Luteinising Hormone (LH), Follicle stimulating hormone (FSH) and oestradiol will be measured every 10 min during the infusions.
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The participant won't know whether they are receiving placebo or which dose of kisspeptin
|
| 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. |
|
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 months |
| 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. | 3 months |
| Dhillo WS, Chaudhri OB, Thompson EL, Murphy KG, Patterson M, Ramachandran R, Nijher GK, Amber V, Kokkinos A, Donaldson M, Ghatei MA, Bloom SR. Kisspeptin-54 stimulates gonadotropin release most potently during the preovulatory phase of the menstrual cycle in women. J Clin Endocrinol Metab. 2007 Oct;92(10):3958-66. doi: 10.1210/jc.2007-1116. Epub 2007 Jul 17. |
| 19820030 | Background | Jayasena CN, Nijher GM, Chaudhri OB, Murphy KG, Ranger A, Lim A, Patel D, Mehta A, Todd C, Ramachandran R, Salem V, Stamp GW, Donaldson M, Ghatei MA, Bloom SR, Dhillo WS. Subcutaneous injection of kisspeptin-54 acutely stimulates gonadotropin secretion in women with hypothalamic amenorrhea, but chronic administration causes tachyphylaxis. J Clin Endocrinol Metab. 2009 Nov;94(11):4315-23. doi: 10.1210/jc.2009-0406. Epub 2009 Oct 9. |
| 20980998 | Background | Jayasena CN, Nijher GM, Abbara A, Murphy KG, Lim A, Patel D, Mehta A, Todd C, Donaldson M, Trew GH, Ghatei MA, Bloom SR, Dhillo WS. Twice-weekly administration of kisspeptin-54 for 8 weeks stimulates release of reproductive hormones in women with hypothalamic amenorrhea. Clin Pharmacol Ther. 2010 Dec;88(6):840-7. doi: 10.1038/clpt.2010.204. Epub 2010 Oct 27. |
| 21976724 | Background | Jayasena CN, Nijher GM, Comninos AN, Abbara A, Januszewki A, Vaal ML, Sriskandarajah L, Murphy KG, Farzad Z, Ghatei MA, Bloom SR, Dhillo WS. The effects of kisspeptin-10 on reproductive hormone release show sexual dimorphism in humans. J Clin Endocrinol Metab. 2011 Dec;96(12):E1963-72. doi: 10.1210/jc.2011-1408. Epub 2011 Oct 5. |
| D000091642 | Urogenital Diseases |
| D017670 |
| Sodium Compounds |