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Trial record 9 of 29 for:    "Turner Syndrome" | "Estrogens"

Pubertal Induction in Individuals With Hypogonadism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02871986
Recruitment Status : Not yet recruiting
First Posted : August 18, 2016
Last Update Posted : August 18, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Primary Amenorrhoea Hypothalamic Amenorrhoea Hypogonadotrophic Hypogonadism Hypopituitarism Turner's Syndrome Primary Ovarian Insufficiency Drug: Routine transdermal oestrogen patch

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.

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Variability of Uterine and Breast Development in Response to Exogenous Oestrogen During Induction of Puberty in Individuals With Hypogonadism.
Study Start Date : September 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2020

Group/Cohort Intervention/treatment
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.
Drug: Routine transdermal oestrogen patch
Transdermal oestrogen patch will be used with an incremental dose increase at 4 months

Primary Outcome Measures :
  1. Uterine dimensions and volume [ Time Frame: Assessment every 2 months for a total of 8 months ]
    transabdominal ultrasound

Secondary Outcome Measures :
  1. Pubertal assessment - Tanner staging [ Time Frame: Assessed every 2 months for a total of 8 months ]
    Conventional tanner staging

  2. Breast Volume assessment [ Time Frame: Assessed every 2 months for a total of 8 months ]
    3d Breast scanning

  3. Height [ Time Frame: Assessed every 2 months for a total of 8 months ]
    Height assessed in metres

  4. Hormonal profile and bone turnover markers [ Time Frame: Assessed every 2 months for a total of 8 months ]
    blood tests

  5. Bone health [ Time Frame: Assessed at baseline and at 8 months ]
    Routine DEXA scan

  6. Inter and intra observer reproducibility of uterine and ovarian measurements in transabdominal ultrasound [ Time Frame: Assessed once during the 8 month study period ]
    Repeat assessment by another observer

  7. Weight [ Time Frame: Assessed every 2 months for a total of 8 months ]
    Weight measured in kg

  8. BMI [ Time Frame: Assessed every 2 months for a total of 8 months ]
    BMI in kg/m^2 (weight measured in kg and height in metres)

  9. Waist and hip circumference [ Time Frame: Assessed every 2 months for a total of 8 months ]
    Measured in mm

  10. Body fat composition [ Time Frame: Assessed every 2 months for a total of 8 months ]
    Measured using standard Tanita

Biospecimen Retention:   Samples With DNA
Blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Individuals with hypogonadism requiring pubertal induction

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02871986

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Contact: Gerard Conway, FRCP, MD 02073809101
Contact: Elizabeth Burt, MRCOG 07919381518

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United Kingdom
University College London Hospital
London, United Kingdom, NW1 2PG
Sponsors and Collaborators
University College, London
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Principal Investigator: Gerard Conway, FRCP, MD UCL

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Responsible Party: University College, London Identifier: NCT02871986     History of Changes
Other Study ID Numbers: 199997
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Peer Review Journals

Additional relevant MeSH terms:
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Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Menopause, Premature
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases