Pubertal Induction in Individuals With Hypogonadism

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Variability of Uterine and Breast Development in Response to Exogenous Oestrogen During Induction of Puberty in Individuals With Hypogonadism.

Conditions
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Primary Amenorrhoea, Hypothalamic Amenorrhoea, Hypogonadotrophic Hypogonadism, Hypopituitarism, Turner's Syndrome, Primary Ovarian Insufficiency

Intervention / Treatment
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* Drug: Routine transdermal oestrogen patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Previous oncology treatment Primary amenorrhoea secondary to chronic medical comorbidity PCOS diagnosis

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals with hypogonadism<br>Individuals with hypogonadism requiring pubertal induction. Participants will receive oestrogen therapy in the form of transdermal oestrogen patch, which is standard care. | Drug: Routine transdermal oestrogen patch<br>* Transdermal oestrogen patch will be used with an incremental dose increase at 4 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine dimensions and volume | transabdominal ultrasound | Assessment every 2 months for a total of 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pubertal assessment - Tanner staging | Conventional tanner staging | Assessed every 2 months for a total of 8 months | 
| Breast Volume assessment | 3d Breast scanning | Assessed every 2 months for a total of 8 months | 
| Height | Height assessed in metres | Assessed every 2 months for a total of 8 months | 
| Hormonal profile and bone turnover markers | blood tests | Assessed every 2 months for a total of 8 months | 
| Bone health | Routine DEXA scan | Assessed at baseline and at 8 months | 
| Inter and intra observer reproducibility of uterine and ovarian measurements in transabdominal ultrasound | Repeat assessment by another observer | Assessed once during the 8 month study period | 
| Weight | Weight measured in kg | Assessed every 2 months for a total of 8 months | 
| BMI | BMI in kg/m^2 (weight measured in kg and height in metres) | Assessed every 2 months for a total of 8 months | 
| Waist and hip circumference | Measured in mm | Assessed every 2 months for a total of 8 months | 
| Body fat composition | Measured using standard Tanita | Assessed every 2 months for a total of 8 months |