Pubertal Induction in Individuals With Hypogonadism

University College London (UCL)

Status: Unknown

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

Treatments: Drug: Routine transdermal oestrogen patch

Study type: Observational

Funder types: Other

Identifiers

NCT02871986

199997

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 10 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 1 patient group

Individuals with hypogonadism

Description:

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

Treatment:

Drug: Routine transdermal oestrogen patch