Growth Hormone DeficiencyNCT05448924
Isolated Growth Hormone Deficiency and Amennorrhea
An observational study of Growth Hormone Deficiency, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
This is a case report of a 14-year old female with no menstruation history. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Hormone panel tests
- How many people
- 1 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2021to 31 Jan 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: This 14-year old female came to the gynaecology clinic with a chief complaint of amenorrhea
Who may be able to join
- A single female participant with amenorrhea
Who cannot join
- The study only included the above subject
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Department of Obstetrics and Gynecology, Universitas Padjadjaran
Bandung, West Java, 40161
About this study
Official title: Isolated Growth Hormone Deficiency and Amennorrhea: Case Report
This is a case report of a 14-year old female with no menstruation history.
Read the detailed description
This is a case report of a 14-year-old with a chief complaint of inability to menstruate. Lab tests were done.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Hormone panel tests
- Keywords
- ISOLATED GROWTH HORMONE DEFICIENCY, AMENORRHEA
- Medical subject headings
- Dwarfism, Pituitary, Amenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone panel testsDiagnostic test
Patient was subjected to a battery of hormone tests, including FSH, LH, estrogen, progesterone and growth hormone
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth hormone levels
Growth hormone levels assessed by hormone panel
Measured: 1 month after testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Dec 2021
- Primary completion1 Jan 2022
- Study completion31 Jan 2022
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 Growth Hormone DeficiencyStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448924
- Sponsor's protocol ID
- OBGY-202206.04
- Status last verified
- Jul 2022
- First submitted
- 26 Jun 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymous patient data may be shared with reasonable written request to the authors
Publications
Crottaz B, Uske A, Reymond MJ, Rey F, Temler E, Germond M, Gomez F. Normogonadotropic primary amenorrhea in a growth hormone-deficient woman with ectopic posterior pituitary: gonadotropin pulsatility and follicle-stimulating hormone bioactivity. J Endocrinol Invest. 1996 Jan;19(1):48-53. doi: 10.1007/BF03347858.
PubMed 8851692
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Growth Hormone Deficiency and Amennorrhea: Case Report
- ClinicalTrials.gov ID
- NCT05448924
- Acronym / sponsor ID
- OBGY-202206.04
- Conditions
- Growth Hormone Deficiency
- Keywords
- ISOLATED GROWTH HORMONE DEFICIENCY, AMENORRHEA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 8 Jul 2022 (actual)
- 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.
This is a case report of a 14-year old female with no menstruation history.
Detailed description
This is a case report of a 14-year-old with a chief complaint of inability to menstruate. Lab tests were done.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This 14-year old female came to the gynaecology clinic with a chief complaint of amenorrhea
Key inclusion criteria (1 listed)
- A single female participant with amenorrhea
Key exclusion criteria (1 listed)
- The study only included the above subject
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 |
|---|---|---|
| Hormone panel testsPatient was subjected to a battery of hormone tests, including FSH, LH, estrogen, progesterone and growth hormone | Diagnostic test | – |
Primary outcome
Growth hormone levels
Time frame: 1 month after testing
Growth hormone levels assessed by hormone panel
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Background: PubMed 8851692Crottaz B, Uske A, Reymond MJ, Rey F, Temler E, Germond M, Gomez F. Normogonadotropic primary amenorrhea in a growth hormone-deficient woman with ectopic posterior pituitary: gonadotropin pulsatility and follicle-stimulating hormone bioactivity. J Endocrinol Invest. 1996 Jan;19(1):48-53. doi: 10.1007/BF03347858.
- Individual participant dataSharing planned: Undecided. Anonymous patient data may be shared with reasonable written request to the authors
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Enrolling by invitationObservational study
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Growth Hormone Deficiency, run by Universitas Padjadjaran at 1 site in Indonesia.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Jul 2022. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth hormone levels (time frame: 1 month after testing). 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 NCT05448924, 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 8 Jul 2022.