Hypogonadotrophic Hypogonadism, Hypopituitarism, Hypothalamic Amenorrhoea, Primary Amenorrhoea, Primary Ovarian Insufficiency, Turner's Syndrome
Conditions
Brief summary
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
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.
Interventions
DRUGRoutine transdermal oestrogen patch
Transdermal oestrogen patch will be used with an incremental dose increase at 4 months
Sponsors
University College, London
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
1. Have a diagnosis of hypogonadism (Turner's syndrome, hypogonadotrophic hypogonadism, primary ovarian insufficiency, hypopituitarism, hypothalamic amenorrhoea, transgender) 2. ≥ 10 years of age 3. Oestrogen naïve i.e. no prior commencement of oestrogen treatment 4. Breast Tanner stage ≤ than 2
Exclusion criteria
1. Previous oncology treatment 2. Primary amenorrhoea secondary to chronic medical comorbidity 3. PCOS diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uterine dimensions and volume | Assessment every 2 months for a total of 8 months | transabdominal ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breast Volume assessment | Assessed every 2 months for a total of 8 months | 3d Breast scanning |
| Height | Assessed every 2 months for a total of 8 months | Height assessed in metres |
| Hormonal profile and bone turnover markers | Assessed every 2 months for a total of 8 months | blood tests |
| Bone health | Assessed at baseline and at 8 months | Routine DEXA scan |
| Pubertal assessment - Tanner staging | Assessed every 2 months for a total of 8 months | Conventional tanner staging |
| Weight | Assessed every 2 months for a total of 8 months | Weight measured in kg |
| BMI | Assessed every 2 months for a total of 8 months | BMI in kg/m\^2 (weight measured in kg and height in metres) |
| Waist and hip circumference | Assessed every 2 months for a total of 8 months | Measured in mm |
| Body fat composition | Assessed every 2 months for a total of 8 months | Measured using standard Tanita |
| Inter and intra observer reproducibility of uterine and ovarian measurements in transabdominal ultrasound | Assessed once during the 8 month study period | Repeat assessment by another observer |
Countries
United Kingdom
Contacts
Primary ContactGerard Conway, FRCP, MD
Backup ContactElizabeth Burt, MRCOG
Outcome results
None listed