NCT02871986

Pubertal Induction in Individuals With Hypogonadism

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 24 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 10 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Routine transdermal oestrogen patch	Transdermal oestrogen patch will be used with an incremental dose increase at 4 months

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-03-01
• Completion: 2020-03-01
• First posted: 2016-08-18
• Last updated: 2016-08-18

Locations

1 site across 1 country: United Kingdom