An observational study in Primary Amenorrhoea, Hypothalamic Amenorrhoea and Hypogonadotrophic Hypogonadism, sponsored by University College, London. Status unknown at 1 site in United Kingdom. Open to participants aged 10 Years to 30 Years. Per ClinicalTrials.gov, last updated 2016-08-18.
Sponsored by University College, London · Observational
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.
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.
320 studies on the registry are indexed under Hypogonadism; 39 are open to participants now.
This study's planned enrollment of 24 is below the median of 106 across 56 observational studies indexed under Hypogonadism.
Browse Hypogonadism studies →University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individuals with hypogonadism requiring pubertal induction
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Transdermal oestrogen patch will be used with an incremental dose increase at 4 months
Uterine dimensions and volume
transabdominal ultrasound
Time frame: Assessment every 2 months for a total of 8 months
Pubertal assessment - Tanner staging
Conventional tanner staging
Time frame: Assessed every 2 months for a total of 8 months
Breast Volume assessment
3d Breast scanning
Time frame: Assessed every 2 months for a total of 8 months
Height
Height assessed in metres
Time frame: Assessed every 2 months for a total of 8 months
Hormonal profile and bone turnover markers
blood tests
Time frame: Assessed every 2 months for a total of 8 months
Bone health
Routine DEXA scan
Time frame: 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
Time frame: Assessed once during the 8 month study period
Weight
Weight measured in kg
Time frame: Assessed every 2 months for a total of 8 months
BMI
BMI in kg/m\^2 (weight measured in kg and height in metres)
Time frame: Assessed every 2 months for a total of 8 months
Waist and hip circumference
Measured in mm
Time frame: Assessed every 2 months for a total of 8 months
Body fat composition
Measured using standard Tanita
Time frame: Assessed every 2 months for a total of 8 months
Plan to share: Yes — Peer Review Journals
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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