HyperandrogenemiaNCT01421797
Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation
A study testing Dexamethasone and Cortrosyn in people with Hyperandrogenemia and Polycystic Ovary Syndrome, run by University of Virginia at 1 site in United States.
Trial summary
Women with polycystic ovary syndrome (PCOS) often have irregular menstrual periods, too much facial and body hair, and weight gain. Women with PCOS also have a hard time becoming pregnant. Girls with high levels of the male hormone testosterone often develop PCOS as adults. 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
- Hyperandrogenemia, Polycystic Ovary Syndrome, Obesity
- What is being tested?
- Dexamethasone and Cortrosyn
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2006to Dec 2024
- Phase
- Interventional
- 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 7 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Normal and obese (>95th BMI%) females
- Weight of 24 kg or more
- Early to late puberty (expected age range 7-18)
- Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated LH, lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)
Who cannot join
- Screening labs outside of age-appropriate normal range
- Hemoglobin <12 mg/dL and hematocrit<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still <36%, they will be excluded.)
- Morning Cortisol <5 g/dL
- 17-hydroxyprogesterone >295 ng/dL
- Weight<24 kg
- History of Cushing's syndrome or adrenal insufficiency
- Pregnant (self reported)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Research in Reproduction
Charlottesville, Virginia, 22902
About this study
Official title: Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation (JCM022)
Women with polycystic ovary syndrome (PCOS) often have irregular menstrual periods, too much facial and body hair, and weight gain. Women with PCOS also have a hard time becoming pregnant. Girls with high levels of the male hormone testosterone often develop PCOS as adults. Some girls with high levels of male hormone will develop normal hormone levels as they grow up, but most girls continue to have high levels of male hormone as adults. The purpose of this study is to understand where the male and female hormones come from in girls as they get older. The investigators think the adrenal gland, makes most of the hormones in young girls and that the ovary and the adrenal gland make these hormones in older girls. The investigators would like to find out whether an overactive adrenal gland makes these hormones higher in girls who are overweight, compared to those who are not overweight.
Read the detailed description
We propose that the adrenal gland is the predominant source of the early morning rise in progesterone and testosterone which is more marked in early puberty. Specifically, we hypothesize that dexamethasone administration at 22:00 will be associated with a dampened progesterone and testosterone rise the subsequent morning in normal girls. We also propose that the adrenal gland is the source of the excess androgen production in young obese girls, and that dexamethasone will decrease their early morning testosterone and progesterone levels. We will explore the hypothesis that functional adrenal hyperandrogenism, or ACTH hyperresponsiveness, is one mechanism underlying this excess adrenal androgen production seen in obesity.
- Conditions
- Hyperandrogenemia, Polycystic Ovary Syndrome, Obesity
- Being tested
- Dexamethasone, Cortrosyn
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
1 mg PO
CortrosynDrug
Also called ACTH
single IV bolus of 0.25 mg will be administered
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone, Cortrosyn | Experimental | Dexamethasone given 1 mg PO Cortrosyn given single IV bolus 0f 0.25 mg Receives: Drug: Dexamethasone; Drug: Cortrosyn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls.
A primary endpoint for analysis in this study is the change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls.
Measured: Time frame for the study will be 14 hours (Sampling begins at 1900 hrs and proceeds through 0800 hours the following morning).
Secondary outcomes (2)
Overnight changes in male and female hormones in response to ACTH suppression
Secondary endpoints will include overnight changes in testosterone, estradiol, cortisol, dehydroepiandrosterone (DHEA), and luteinizing hormone (LH) pulse patterns in response to adrenocorticotropic hormone (ACTH) suppression. These secondary endpoints will be evaluated in a similar manner to the primary endpoint.
Measured: 14 hours (Sampling begins at 1900 hours and proceeds through 0800 the following morning)
Response to ACTH stimulation in normal weight and overweight girls
Examine the differences in hormone responses to ACTH in normal weight and overweight girls.
Measured: 14 hours (1900 - 0800 hrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study start10 Oct 2006
- Primary completion27 Aug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperandrogenemiaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, San Diego
- Responsible party
- Principal investigator, Christine Burt Solorzano, University of Virginia
- Investigators
- Christine Burt Solorzano, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421797
- Sponsor's protocol ID
- 12702
- Other IDs
- JCM022, U54HD028934-18, 12702
- Status last verified
- Oct 2023
- First submitted
- 19 Aug 2011
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adrenal Androgens in Normal and Obese Girls After Suppression and Stimulation (JCM022)
- ClinicalTrials.gov ID
- NCT01421797
- Acronym / sponsor ID
- 12702
- Conditions
- Hyperandrogenemia, Polycystic Ovary Syndrome, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of California, San Diego
- Study start
- 10 Oct 2006 (actual)
- Primary completion
- 27 Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Aug 2011 (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.
Women with polycystic ovary syndrome (PCOS) often have irregular menstrual periods, too much facial and body hair, and weight gain. Women with PCOS also have a hard time becoming pregnant. Girls with high levels of the male hormone testosterone often develop PCOS as adults. Some girls with high levels of male hormone will develop normal hormone levels as they grow up, but most girls continue to have high levels of male hormone as adults. The purpose of this study is to understand where the male and female hormones come from in girls as they get older. The investigators think the adrenal gland, makes most of the hormones in young girls and that the ovary and the adrenal gland make these hormones in older girls. The investigators would like to find out whether an overactive adrenal gland makes these hormones higher in girls who are overweight, compared to those who are not overweight.
Detailed description
We propose that the adrenal gland is the predominant source of the early morning rise in progesterone and testosterone which is more marked in early puberty. Specifically, we hypothesize that dexamethasone administration at 22:00 will be associated with a dampened progesterone and testosterone rise the subsequent morning in normal girls. We also propose that the adrenal gland is the source of the excess androgen production in young obese girls, and that dexamethasone will decrease their early morning testosterone and progesterone levels. We will explore the hypothesis that functional adrenal hyperandrogenism, or ACTH hyperresponsiveness, is one mechanism underlying this excess adrenal androgen production seen in obesity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone, Cortrosyn | Experimental | Drug: Dexamethasone, Drug: CortrosynDexamethasone given 1 mg PO Cortrosyn given single IV bolus 0f 0.25 mg |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Normal and obese (>95th BMI%) females
- Weight of 24 kg or more
- Early to late puberty (expected age range 7-18)
- Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated LH, lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)
Key exclusion criteria (7 listed)
- Screening labs outside of age-appropriate normal range
- Hemoglobin <12 mg/dL and hematocrit<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still <36%, they will be excluded.)
- Morning Cortisol <5 g/dL
- 17-hydroxyprogesterone >295 ng/dL
- Weight<24 kg
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 |
|---|---|---|
| Dexamethasone1 mg PO | Drug | Dexamethasone, Cortrosyn |
| CortrosynAlso: ACTHsingle IV bolus of 0.25 mg will be administered | Drug | Dexamethasone, Cortrosyn |
Primary outcome
Change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls.
Time frame: Time frame for the study will be 14 hours (Sampling begins at 1900 hrs and proceeds through 0800 hours the following morning).
A primary endpoint for analysis in this study is the change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls.
2 secondary outcomes
Overnight changes in male and female hormones in response to ACTH suppression
Time frame: 14 hours (Sampling begins at 1900 hours and proceeds through 0800 the following morning)
Response to ACTH stimulation in normal weight and overweight girls
Time frame: 14 hours (1900 - 0800 hrs)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
Related trials for Hyperandrogenemia
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Overweight and Obesity, Hyperandrogenemia
Recruiting
Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome
Polycystic Ovary Syndrome
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Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
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Hyperandrogenemia and Altered Day-night LH Pulse Patterns
Hyperandrogenism, Polycystic Ovary 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.
Christine Burt Solorzano, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Cortrosyn in people with Hyperandrogenemia and Polycystic Ovary Syndrome, run by University of Virginia 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 7 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 27 Oct 2023. 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.
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?
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?
Change in progesterone concentrations from the 2100-2300 time block to the 0500-0700 time block in normal weight girls compared to overweight girls. (time frame: Time frame for the study will be 14 hours (Sampling begins at 1900 hrs and proceeds through 0800 hours the following morning).). 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 27 Oct 2023.