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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 August 2016 |
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Main ID: |
NCT02871986 |
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Date of registration:
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26/07/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pubertal Induction in Individuals With Hypogonadism
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Scientific title:
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Variability of Uterine and Breast Development in Response to Exogenous Oestrogen During Induction of Puberty in Individuals With Hypogonadism. |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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24 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02871986 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Gerard Conway, FRCP, MD |
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Address:
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Telephone:
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02073809101 |
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Email:
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g.conway@ucl.ac.uk |
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Affiliation:
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Name:
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Gerard Conway, FRCP, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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UCL |
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Key inclusion & exclusion criteria
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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
Age minimum:
10 Years
Age maximum:
30 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypothalamic Amenorrhoea
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Hypopituitarism
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Hypogonadotrophic Hypogonadism
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Primary Amenorrhoea
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Primary Ovarian Insufficiency
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Turner's Syndrome
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Intervention(s)
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Drug: Routine transdermal oestrogen patch
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Primary Outcome(s)
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Uterine dimensions and volume
[Time Frame: Assessment every 2 months for a total of 8 months]
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Secondary Outcome(s)
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Breast Volume assessment
[Time Frame: Assessed every 2 months for a total of 8 months]
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Waist and hip circumference
[Time Frame: Assessed every 2 months for a total of 8 months]
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Height
[Time Frame: Assessed every 2 months for a total of 8 months]
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Inter and intra observer reproducibility of uterine and ovarian measurements in transabdominal ultrasound
[Time Frame: Assessed once during the 8 month study period]
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BMI
[Time Frame: Assessed every 2 months for a total of 8 months]
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Bone health
[Time Frame: Assessed at baseline and at 8 months]
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Pubertal assessment - Tanner staging
[Time Frame: Assessed every 2 months for a total of 8 months]
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Hormonal profile and bone turnover markers
[Time Frame: Assessed every 2 months for a total of 8 months]
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Weight
[Time Frame: Assessed every 2 months for a total of 8 months]
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Body fat composition
[Time Frame: Assessed every 2 months for a total of 8 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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