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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with hypogonadism | Individuals with hypogonadism requiring pubertal induction. Participants will receive oestrogen therapy in the form of transdermal oestrogen patch, which is standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine transdermal oestrogen patch | Drug | Transdermal oestrogen patch will be used with an incremental dose increase at 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uterine dimensions and volume | transabdominal ultrasound | Assessment every 2 months for a total of 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pubertal assessment - Tanner staging | Conventional tanner staging | Assessed every 2 months for a total of 8 months |
| Breast Volume assessment | 3d Breast scanning |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with hypogonadism requiring pubertal induction
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerard Conway, FRCP, MD | Contact | 02073809101 | g.conway@ucl.ac.uk | |
| Elizabeth Burt, MRCOG | Contact | 07919381518 | elizabeth.burt@uclh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Gerard Conway, FRCP, MD | UCL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London Hospital | London | London | NW1 2PG | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35436365 | Derived | Burt E, Yasmin E, Davies MC, Creighton S, Brain C, Ruff C, Learner HI, Williams L, Cameron-Pimblett A, Talaulikar V, Conway G. Variability of response to early puberty induction demonstrated by transverse uterine diameter measurement and a novel method of 3D breast imaging. Clin Endocrinol (Oxf). 2022 Jul;97(1):91-99. doi: 10.1111/cen.14740. Epub 2022 Apr 22. |
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Peer Review Journals
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D007018 | Hypopituitarism |
| D014424 | Turner Syndrome |
| D016649 | Primary Ovarian Insufficiency |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
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Blood samples
| Assessed every 2 months for a total of 8 months |
| Height | Height assessed in metres | Assessed every 2 months for a total of 8 months |
| Hormonal profile and bone turnover markers | blood tests | Assessed every 2 months for a total of 8 months |
| Bone health | Routine DEXA scan | 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 | Assessed once during the 8 month study period |
| Weight | Weight measured in kg | Assessed every 2 months for a total of 8 months |
| BMI | BMI in kg/m^2 (weight measured in kg and height in metres) | Assessed every 2 months for a total of 8 months |
| Waist and hip circumference | Measured in mm | Assessed every 2 months for a total of 8 months |
| Body fat composition | Measured using standard Tanita | Assessed every 2 months for a total of 8 months |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006059 | Gonadal Dysgenesis |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D058533 | Sex Chromosome Disorders of Sex Development |
| D052801 | Male Urogenital Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |