NCT02871986

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

August 18, 2016

Status Verified

June 1, 2016

Enrollment Period

1.5 years

First QC Date

July 26, 2016

Last Update Submit

August 15, 2016

Conditions

Primary AmenorrhoeaHypothalamic AmenorrhoeaHypogonadotrophic HypogonadismHypopituitarismTurner's SyndromePrimary Ovarian Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Uterine dimensions and volume

    transabdominal ultrasound

    Assessment every 2 months for a total of 8 months

Secondary Outcomes (10)

  • Pubertal assessment - Tanner staging

    Assessed every 2 months for a total of 8 months

  • Breast Volume assessment

    Assessed every 2 months for a total of 8 months

  • Height

    Assessed every 2 months for a total of 8 months

  • Hormonal profile and bone turnover markers

    Assessed every 2 months for a total of 8 months

  • Bone health

    Assessed at baseline and at 8 months

  • +5 more secondary outcomes

Study Arms (1)

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

Interventions

Routine transdermal oestrogen patchDRUG

Transdermal oestrogen patch will be used with an incremental dose increase at 4 months

Individuals with hypogonadism

Eligibility Criteria

Age10 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Individuals with hypogonadism requiring pubertal induction

You may qualify if:

  • 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

You may not qualify if:

  • Previous oncology treatment
  • Primary amenorrhoea secondary to chronic medical comorbidity
  • PCOS diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London Hospital

London, London, NW1 2PG, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 35436365DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

HypogonadismHypopituitarismTurner SyndromePrimary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSex Chromosome Disorders of Sex DevelopmentMale Urogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSex Chromosome DisordersChromosome DisordersGenetic Diseases, InbornOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Diseases

Study Officials

  • Gerard Conway, FRCP, MD

    UCL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerard Conway, FRCP, MD

CONTACT

02073809101g.conway@ucl.ac.uk

Elizabeth Burt, MRCOG

CONTACT

07919381518elizabeth.burt@uclh.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 18, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2020

Last Updated

August 18, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will share

Peer Review Journals

Locations

GB(1)