Variability of Uterine and Breast Development in Response to Exogenous Oestrogen During Induction of Puberty in Individuals With Hypogonadism.
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Uterine dimensions and volume
研究概览
简要总结
The investigators wish to explore the variability of uterine, breast and bone outcome markers as surrogates to assess the adequacy of exogenous oestrogen replacement in individuals with hypogonadism.
详细描述
The investigators will invite individuals with hypogonadism who require pubertal induction to participate in the study. The participants will receive conventional routine oestrogen replacement in the form of transdermal patch. The participants will be reviewed every 2 months for a total of 8 months to document uterine, breast and bone assessment. This will be completed using a variety of tools. After 4 months, the participants will receive an incremental increase in oestrogen dose.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of hypogonadism (Turner's syndrome, hypogonadotrophic hypogonadism, primary ovarian insufficiency, hypopituitarism, hypothalamic amenorrhoea, transgender)
- •≥ 10 years of age
- •Oestrogen naïve i.e. no prior commencement of oestrogen treatment
- •Breast Tanner stage ≤ than 2
排除标准
- •Previous oncology treatment
- •Primary amenorrhoea secondary to chronic medical comorbidity
- •PCOS diagnosis
研究组 & 干预措施
Individuals with hypogonadism
Individuals with hypogonadism requiring pubertal induction. Participants will receive oestrogen therapy in the form of transdermal oestrogen patch, which is standard care.
干预措施: Routine transdermal oestrogen patch (Drug)
结局指标
主要结局
Uterine dimensions and volume
时间窗: Assessment every 2 months for a total of 8 months
transabdominal ultrasound
次要结局
- Breast Volume assessment(Assessed every 2 months for a total of 8 months)
- Height(Assessed every 2 months for a total of 8 months)
- Bone health(Assessed at baseline and at 8 months)
- Pubertal assessment - Tanner staging(Assessed every 2 months for a total of 8 months)
- Hormonal profile and bone turnover markers(Assessed every 2 months for a total of 8 months)
- Inter and intra observer reproducibility of uterine and ovarian measurements in transabdominal ultrasound(Assessed once during the 8 month study period)
- Weight(Assessed every 2 months for a total of 8 months)
- BMI(Assessed every 2 months for a total of 8 months)
- Waist and hip circumference(Assessed every 2 months for a total of 8 months)
- Body fat composition(Assessed every 2 months for a total of 8 months)