Pubertal Induction in Individuals With Hypogonadism

• Conditions: Primary Amenorrhoea; Hypothalamic Amenorrhoea; Turner's Syndrome; Hypogonadotrophic Hypogonadism; Hypopituitarism; Primary Ovarian Insufficiency
• Interventions: Drug: Routine transdermal oestrogen patch

• Registration Number: NCT02871986
• Lead Sponsor: University College, London

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.

Study Timeline

• Status Verified: 2016-06
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-08-15
• Last Update Submitted: 2016-08-15
• Study First Posted: 2016-08-18
• Last Update Posted: 2016-08-18
• Study Start: 2016-09
• Primary Completion: 2018-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals with hypogonadism	Routine transdermal oestrogen patch	Individuals with hypogonadism requiring pubertal induction. Participants will receive oestrogen therapy in the form of transdermal oestrogen patch, which is standard care.

Primary Outcome Measures

Name	Time	Method
Uterine dimensions and volume	Assessment every 2 months for a total of 8 months	transabdominal ultrasound

Secondary Outcome Measures

Name	Time	Method
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
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
Hormonal profile and bone turnover markers	Assessed every 2 months for a total of 8 months	blood tests
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
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

Trial Locations

Locations (1)

University College London Hospital; 🇬🇧 London, United Kingdom