Pubertal Induction in Individuals With Hypogonadism

Primary Ovarian Insufficiency Clinical Trial

Official title:

Variability of Uterine and Breast Development in Response to Exogenous Oestrogen During Induction of Puberty in Individuals With Hypogonadism.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02871986
• Other study ID #: 199997
• Status: Not yet recruiting
• Phase: N/A
• First received: July 26, 2016
• Last updated: August 15, 2016
• Start date: September 2016
• Est. completion date: March 2020

Study information

• Verified date: June 2016
• Source: University College, London
• Contact: Gerard Conway, FRCP, MD
• Phone: 02073809101
• Email: g.conway[@]ucl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: March 2020
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 30 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Amenorrhea
• Gonadal Dysgenesis
• Hypogonadism
• Hypogonadotrophic Hypogonadism
• Hypopituitarism
• Hypothalamic Amenorrhoea
• Primary Amenorrhoea
• Primary Ovarian Insufficiency
• Turner Syndrome
• Turner's Syndrome

Intervention

Drug:
• Routine transdermal oestrogen patch
Transdermal oestrogen patch will be used with an incremental dose increase at 4 months

Locations

Country	Name	City	State
United Kingdom	University College London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine dimensions and volume	transabdominal ultrasound	Assessment every 2 months for a total of 8 months	No
Secondary	Pubertal assessment - Tanner staging	Conventional tanner staging	Assessed every 2 months for a total of 8 months	No
Secondary	Breast Volume assessment	3d Breast scanning	Assessed every 2 months for a total of 8 months	No
Secondary	Height	Height assessed in metres	Assessed every 2 months for a total of 8 months	No
Secondary	Hormonal profile and bone turnover markers	blood tests	Assessed every 2 months for a total of 8 months	No
Secondary	Bone health	Routine DEXA scan	Assessed at baseline and at 8 months	No
Secondary	Inter and intra observer reproducibility of uterine and ovarian measurements in transabdominal ultrasound	Repeat assessment by another observer	Assessed once during the 8 month study period	No
Secondary	Weight	Weight measured in kg	Assessed every 2 months for a total of 8 months	No
Secondary	BMI	BMI in kg/m^2 (weight measured in kg and height in metres)	Assessed every 2 months for a total of 8 months	No
Secondary	Waist and hip circumference	Measured in mm	Assessed every 2 months for a total of 8 months	No
Secondary	Body fat composition	Measured using standard Tanita	Assessed every 2 months for a total of 8 months	No