Primary AmenorrhoeaNCT02871986
Pubertal Induction in Individuals With Hypogonadism
An observational study of Primary Amenorrhoea and Hypothalamic Amenorrhoea, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 10 to 30 years
- Conditions the study is for
- Primary Amenorrhoea, Hypothalamic Amenorrhoea, Hypogonadotrophic Hypogonadism
- What is being tested?
- Routine transdermal oestrogen patch
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Individuals with hypogonadism requiring pubertal induction
Who may be able to join
- Have a diagnosis of hypogonadism (Turner's syndrome, hypogonadotrophic hypogonadism, primary ovarian insufficiency, hypopituitarism, hypothalamic amenorrhoea, transgender)
- ≥ 10 years of age
- Oestrogen naïve i.e. no prior commencement of oestrogen treatment
- Breast Tanner stage ≤ than 2
Who cannot join
- Previous oncology treatment
- Primary amenorrhoea secondary to chronic medical comorbidity
- PCOS diagnosis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospital
London, London, NW1 2PG
About this study
Official title: Variability of Uterine and Breast Development in Response to Exogenous Oestrogen During Induction of Puberty in Individuals With Hypogonadism.
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.
Read the 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
- Being tested
- Routine transdermal oestrogen patch
- Medical subject headings
- Hypogonadism, Hypopituitarism, Turner Syndrome, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine transdermal oestrogen patchDrug
Transdermal oestrogen patch will be used with an incremental dose increase at 4 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Routine transdermal oestrogen patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine dimensions and volume
transabdominal ultrasound
Measured: Assessment every 2 months for a total of 8 months
Secondary outcomes (10)
Pubertal assessment - Tanner staging
Conventional tanner staging
Measured: Assessed every 2 months for a total of 8 months
Breast Volume assessment
3d Breast scanning
Measured: Assessed every 2 months for a total of 8 months
Height
Height assessed in metres
Measured: Assessed every 2 months for a total of 8 months
Hormonal profile and bone turnover markers
blood tests
Measured: Assessed every 2 months for a total of 8 months
Bone health
Routine DEXA scan
Measured: 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
Measured: Assessed once during the 8 month study period
Weight
Weight measured in kg
Measured: Assessed every 2 months for a total of 8 months
BMI
BMI in kg/m^2 (weight measured in kg and height in metres)
Measured: Assessed every 2 months for a total of 8 months
Waist and hip circumference
Measured in mm
Measured: Assessed every 2 months for a total of 8 months
Body fat composition
Measured using standard Tanita
Measured: Assessed every 2 months for a total of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary AmenorrhoeaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerard Conway, FRCP, MD, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871986
- Sponsor's protocol ID
- 199997
- Status last verified
- Jun 2016
- First submitted
- 26 Jul 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Peer Review Journals
Publications
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.
PubMed 35436365
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability of Uterine and Breast Development in Response to Exogenous Oestrogen During Induction of Puberty in Individuals With Hypogonadism.
- ClinicalTrials.gov ID
- NCT02871986
- Acronym / sponsor ID
- 199997
- Conditions
- Primary Amenorrhoea, Hypothalamic Amenorrhoea, Hypogonadotrophic Hypogonadism, Hypopituitarism, Turner's Syndrome, Primary Ovarian Insufficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with hypogonadism | – | Drug: Routine transdermal oestrogen patchIndividuals with hypogonadism requiring pubertal induction. Participants will receive oestrogen therapy in the form of transdermal oestrogen patch, which is standard care. |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Individuals with hypogonadism requiring pubertal induction
Key inclusion criteria (4 listed)
- Have a diagnosis of hypogonadism (Turner's syndrome, hypogonadotrophic hypogonadism, primary ovarian insufficiency, hypopituitarism, hypothalamic amenorrhoea, transgender)
- ≥ 10 years of age
- Oestrogen naïve i.e. no prior commencement of oestrogen treatment
- Breast Tanner stage ≤ than 2
Key exclusion criteria (3 listed)
- Previous oncology treatment
- Primary amenorrhoea secondary to chronic medical comorbidity
- PCOS diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine transdermal oestrogen patchTransdermal oestrogen patch will be used with an incremental dose increase at 4 months | Drug | Individuals with hypogonadism |
Primary outcome
Uterine dimensions and volume
Time frame: Assessment every 2 months for a total of 8 months
transabdominal ultrasound
10 secondary outcomes
Pubertal assessment - Tanner staging
Time frame: Assessed every 2 months for a total of 8 months
Breast Volume assessment
Time frame: Assessed every 2 months for a total of 8 months
Height
Time frame: Assessed every 2 months for a total of 8 months
Hormonal profile and bone turnover markers
Time frame: Assessed every 2 months for a total of 8 months
Bone health
Time frame: Assessed at baseline and at 8 months
Inter and intra observer reproducibility of uterine and ovarian measurements in transabdominal ultrasound
Time frame: Assessed once during the 8 month study period
Weight
Time frame: Assessed every 2 months for a total of 8 months
BMI
Time frame: Assessed every 2 months for a total of 8 months
Waist and hip circumference
Time frame: Assessed every 2 months for a total of 8 months
Body fat composition
Time frame: Assessed every 2 months for a total of 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Derived from this study: PubMed 35436365Burt 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.
- Individual participant dataSharing planned: Yes. Peer Review Journals
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Conway, FRCP, MD principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Amenorrhoea and Hypothalamic Amenorrhoea, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerard Conway, FRCP, MD (02073809101, g.conway@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine dimensions and volume (time frame: Assessment every 2 months for a total of 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02871986, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2016.