DevelopmentPhase 3NCT01062568
The Adrenal Contribution to Androgen Production in Girls During Puberty
A Phase 3 study testing Adrenocorticotropin and Dexamethasone in people with Development, run by University of California, San Diego at 1 site in United States.
Trial summary
In girls with elevated androgens the precise source of androgen excess throughout puberty and early adolescence has not been carefully examined. The investigators propose to examine whether the adrenal gland produces the majority of androgens during puberty by studying the differences in androgen responses to… Read more about this study
- Who is it for?
- Ages 7 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Development
- What is being tested?
- Adrenocorticotropin and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jul 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Normal CBC (Hemoglobin must be at least 11mg/dl)
- Normal renal and liver function tests (AST\& ALT 10-45 IU/L; Albumin 3.3-5 g/dL; Alk phos 30-130 IU/L;
- direct bili <0.2 mg/dL;
- total bili <1.2 mg/dL; total protein 6.0-8.0 g/dL) Normal vital signs including normal blood pressure (pulse 60-100/min, respirations 12-20/min, BP 80/60-130/80)
Who cannot join
- Pregnancy
- On oral contraceptives
- On insulin lowering drugs
- On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)
- On medications that will influence androgen metabolism or clearance
- On medications that will inhibit the cytochrome P450 enzyme system (cimetidine, ketoconazole, etc)
Show all 9Show fewer
- Subjects with morning cortisol<5 ug/dL will be excluded and asked to see their primary care physician.
- Subjects with 17-OHP>250 ng/dL) will be excluded and asked to see their primary care physician.
- Subject with a history of Cushing syndrome or adrenal insufficiency will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of california, san diego
La Jolla, California, 92037
About this study
In girls with elevated androgens the precise source of androgen excess throughout puberty and early adolescence has not been carefully examined. The investigators propose to examine whether the adrenal gland produces the majority of androgens during puberty by studying the differences in androgen responses to adrenocorticotropin hormone (ACTH) administration in normal weight (NW) and obese (OB) girls ages 7-18. The investigators' analyses will compare steroid changes before and 60 min after ACTH administration in NW and OB girls.
Read the detailed description
Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, 0.25 mg adrenocorticotropin hormone (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
- Conditions
- Development
- Being tested
- Adrenocorticotropin, Dexamethasone
- Keywords
- adolescents, puberty, androgens, hyperandrogenemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrenocorticotropinDrug
Also called Cosyntropin, ACTH
Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
DexamethasoneDrug
Also called dex
Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, 0.25 mg adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
| Study group | Role | What they receive |
|---|---|---|
| Obese group | Experimental | Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements. Receives: Drug: Adrenocorticotropin; Drug: Dexamethasone |
| Nonobese group | Experimental | Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements. Receives: Drug: Adrenocorticotropin; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-hydroxyprogesterone Response to ACTH
17-hyrooxyprogesterone levels before and after ACTH
Measured: 0 and 60 minutes after ACTH administration
Secondary outcomes (2)
Free Testosterone Response to ACTH
Free Testosteorne levels before and after ACTH
Measured: 0 and 60 min after ACTH administration
Androstenedione Response to ACTH
Androstenedione levels before and after ACTH
Measured: 0 and 60 min after ACTH administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DevelopmentStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Chang, MD, University of California, San Diego
- Investigators
- R J Chang, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062568
- Sponsor's protocol ID
- 091676
- Status last verified
- Aug 2019
- First submitted
- 3 Feb 2010
- Last updated
- 26 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adrenal Contribution to Androgen Production in Girls During Puberty
- ClinicalTrials.gov ID
- NCT01062568
- Acronym / sponsor ID
- 091676
- Conditions
- Development
- Keywords
- adolescents, puberty, androgens, hyperandrogenemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Feb 2010 (estimated)
- Results
- Posted 26 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In girls with elevated androgens the precise source of androgen excess throughout puberty and early adolescence has not been carefully examined. The investigators propose to examine whether the adrenal gland produces the majority of androgens during puberty by studying the differences in androgen responses to adrenocorticotropin hormone (ACTH) administration in normal weight (NW) and obese (OB) girls ages 7-18. The investigators' analyses will compare steroid changes before and 60 min after ACTH administration in NW and OB girls.
Detailed description
Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, 0.25 mg adrenocorticotropin hormone (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese group | Experimental | Drug: Adrenocorticotropin, Drug: DexamethasoneSubjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements. |
| Nonobese group | Experimental | Drug: Adrenocorticotropin, Drug: DexamethasoneSubjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Normal CBC (Hemoglobin must be at least 11mg/dl)
- Normal renal and liver function tests (AST\& ALT 10-45 IU/L; Albumin 3.3-5 g/dL; Alk phos 30-130 IU/L;
- direct bili <0.2 mg/dL;
- total bili <1.2 mg/dL; total protein 6.0-8.0 g/dL) Normal vital signs including normal blood pressure (pulse 60-100/min, respirations 12-20/min, BP 80/60-130/80)
Key exclusion criteria (9 listed)
- Pregnancy
- On oral contraceptives
- On insulin lowering drugs
- On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)
- On medications that will influence androgen metabolism or clearance
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 |
|---|---|---|
| AdrenocorticotropinAlso: Cosyntropin, ACTHSubjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements. | Drug | Nonobese group, Obese group |
| DexamethasoneAlso: dexSubjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, 0.25 mg adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements. | Drug | Nonobese group, Obese group |
Primary outcome
17-hydroxyprogesterone Response to ACTH
Time frame: 0 and 60 minutes after ACTH administration
17-hyrooxyprogesterone levels before and after ACTH
2 secondary outcomes
Free Testosterone Response to ACTH
Time frame: 0 and 60 min after ACTH administration
Androstenedione Response to ACTH
Time frame: 0 and 60 min after ACTH administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Development
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
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.
R J Chang, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adrenocorticotropin and Dexamethasone in people with Development, run by University of California, San Diego at 1 site in United States.
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 9 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 26 Aug 2019. 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 States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
17-hydroxyprogesterone Response to ACTH (time frame: 0 and 60 minutes after ACTH administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2019.