Pubertal Induction in Individuals With Hypogonadism

N/AUnknownNCT02871986

University College, London24 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Routine transdermal oestrogen patchDRUG

Transdermal oestrogen patch will be used with an incremental dose increase at 4 months

Eligibility

Sex: ALLMin age: 10 YearsMax age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

University College London Hospital

London, London, United Kingdom

Outcomes

Primary Outcomes

Uterine dimensions and volume

transabdominal ultrasound

Time frame: Assessment every 2 months for a total of 8 months

Secondary Outcomes

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)

Central Contacts

Gerard Conway, FRCP, MD

CONTACT

02073809101 g.conway@ucl.ac.uk

Elizabeth Burt, MRCOG

CONTACT

07919381518 elizabeth.burt@uclh.nhs.uk

Data from ClinicalTrials.gov

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