Clinical trial NCT02871986: Pubertal Induction in Individuals With Hypogonadism
Official title: Variability of Uterine and Breast Development in Response to Exogenous Oestrogen During Induction of Puberty in Individuals With Hypogonadism.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Amenorrhoea
Hypothalamic Amenorrhoea
Hypogonadotrophic Hypogonadism
Hypopituitarism
Turner's Syndrome
Primary Ovarian Insufficiency
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with hypogonadism requiring pubertal induction

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.

Eligibility criteria: 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

Primary outcomes:
measure: Uterine dimensions and volume
timeFrame: Assessment every 2 months for a total of 8 months
Secondary outcomes:
measure: Pubertal assessment - Tanner staging
timeFrame: Assessed every 2 months for a total of 8 months
measure: Breast Volume assessment
timeFrame: Assessed every 2 months for a total of 8 months
measure: Height
timeFrame: Assessed every 2 months for a total of 8 months
measure: Hormonal profile and bone turnover markers
timeFrame: Assessed every 2 months for a total of 8 months
measure: Bone health
timeFrame: Assessed at baseline and at 8 months
measure: Inter and intra observer reproducibility of uterine and ovarian measurements in transabdominal ultrasound
timeFrame: Assessed once during the 8 month study period
measure: Weight
timeFrame: Assessed every 2 months for a total of 8 months
measure: BMI
timeFrame: Assessed every 2 months for a total of 8 months
measure: Waist and hip circumference
timeFrame: Assessed every 2 months for a total of 8 months
measure: Body fat composition
timeFrame: Assessed every 2 months for a total of 8 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
affiliation: UCL
name: Gerard Conway, FRCP, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burt E, Yasmin E, Davies MC, Creighton S, Brain C, Ruff C, Learner HI, Williams L, Cameron-Pimblett A, Talaulikar V, Conway G. Variability of response to early puberty induction demonstrated by transverse uterine diameter measurement and a novel method of 3D breast imaging. Clin Endocrinol (Oxf). 2022 Jul;97(1):91-99. doi: 10.1111/cen.14740. Epub 2022 Apr 22.