The Physiological Changes in Reproductive Hormones During Sustained Administration of Kisspeptin in Humans.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Effect of Kisspeptin on hypothalamic reproductive function - LH levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The participant won't know whether they are receiving placebo or which dose of kisspeptin
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-60 years old
- •Ability to give informed consent
- •Secondary hypogonadism (or healthy participant)
排除标准
- •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
研究组 & 干预措施
Kisspeptin 0.1
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.
干预措施: Kisspeptin 0.1 (Other)
Saline
Participants will receive placebo (saline) via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.
干预措施: Saline (Other)
Kisspeptin 0.3
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.
干预措施: Kisspeptin 0.3 (Other)
Kisspeptin 1.0
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.
干预措施: Kisspeptin 1.0 (Other)
结局指标
主要结局
Effect of Kisspeptin on hypothalamic reproductive function - LH levels
时间窗: 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
次要结局
- Do participants with normal fertility respond differently to sustained administration of kisspeptin, compared to participants with reduced fertility?(3 months)
- Effect of Kisspeptin on hypothalamic reproductive function - Oestradiol levels(3 months)
- Effect of Kisspeptin on hypothalamic reproductive function - FSH levels(3 months)