HyperandrogenismCRM005NCT00930007
Sleep-wake Changes of Luteinizing Hormone Frequency in Pubertal Girls With and Without High Testosterone
An observational study of Hyperandrogenism, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to determine whether sleep-wake changes of luteinizing hormone pulse frequency are different in early pubertal girls with high testosterone levels compared to early pubertal girls with normal testosterone levels. Read more about this study
- Who is it for?
- Ages 8 to 15 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperandrogenism
- What is being tested?
- Blood sampling
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Aug 2023
- 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 8 to 15 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Community sample and patients from local clinics
Who may be able to join
- Early to midpubertal girls (late Tanner 1 [i.e., estradiol > 20 pg/ml] to Tanner 3)
- Premenarcheal
- Approximate ages, 8-15 years
Who cannot join
- BMI-for-age < 5th percentile
- Inability to comprehend what will be done during the study or why it will be done
- Being a study of GnRH pulse regulation in adolescent girls with and without HA, boys are excluded
- Obesity associated with a diagnosed (genetic) syndrome (e.g., Prader-Willi syndrome, leptin deficiency), obesity related to medications (e.g., glucocorticoids), etc.
- Pregnancy or lactation
- Virilization
Show all 24Show fewer
- Total testosterone > 150 ng/dl (confirmed on repeat)
- DHEAS > upper limit of age-appropriate normal range (confirmed on repeat) (mild elevations may be seen in adolescent HA, and elevations < 1.5 times the age-appropriate upper limit of normal will be accepted in such girls)
- Follicular phase 17-hydroxyprogesterone > 250 ng/dl (for girls < 12 years old) or > 300 ng/dl (for girls 12 and older) (confirmed on repeat), which suggests the possibility of congenital adrenal hyperplasia. NOTE: If an elevated follicular 17-hydroxyprogesterone is confirmed on repeat testing, an ACTH stimulated 17-hydroxyprogesterone < 1000 ng/dl will be required for study participation
- History of premature adrenarche (i.e., appearance of pubic and/or axillary hair before age 8)
- A previous diagnosis of diabetes
- Fasting glucose ≥ 126 mg/dl, or a hemoglobin A1c > 6.5% (confirmed on repeat)
- Abnormal TSH (confirmed on repeat) (subjects with adequately treated hypothyroidism, reflected by normal TSH values, will not be excluded)
- Abnormal prolactin (confirmed on repeat) (mild elevations may be seen in HA girls, and elevations < 1.5 times the upper limit of normal will be accepted in this group)
- Evidence of Cushing's syndrome by history or physical exam (e.g., history of impaired growth in children, striae)
- Hematocrit < 36% and hemoglobin < 12 g/dl (confirmed on repeat)
- Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
- Persistent liver test abnormalities (confirmed on repeat), with the exception that mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome
- Persistently abnormal sodium, potassium, or elevated creatinine concentration (confirmed on repeat)
- Bicarbonate concentrations < 20 or > 30 (confirmed on repeat)
- No medications known to affect the reproductive system, glucose metabolism, lipid metabolism, or blood pressure can be taken in the 3 months prior to the first inpatient GCRC study (or in the 2 months prior to screening)
- Such medications include oral contraceptive pills, progestins, metformin, glucocorticoids, psychotropics, and sympathomimetics/stimulants (e.g., methylphenidate)
- Patients taking restricted medications will be excluded unless written permission (for the subjects to discontinue the medication) is received from the subject's physician
- Weight < 22 kg is an absolute exclusion criterion (to ensure safe blood withdrawal)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Comparison of Sleep-wake LH Frequency in Peripubertal Girls With and Without Hyperandrogenemia
The purpose of this study is to determine whether sleep-wake changes of luteinizing hormone pulse frequency are different in early pubertal girls with high testosterone levels compared to early pubertal girls with normal testosterone levels.
Read the detailed description
During early puberty, luteinizing hormone (LH) pulse frequency normally increases during sleep. In contrast, preliminary data suggest that obese girls (who have high testosterone levels in general) demonstrate low LH frequency during the day and night during early puberty; but at mid puberty rapidly transition to a high LH frequency during the day and night. We hypothesize that in early pubertal girls with high testosterone levels, overnight increases of LH frequency are less prominent than those observed in early pubertal girls with normal testosterone levels. We will assess this using a frequent sampling protocol for assessment of LH pulse frequency (with sampling occurring while awake and while asleep) in early pubertal girls with and without high testosterone levels. Sleep will be formally evaluated.
- Conditions
- Hyperandrogenism
- Being tested
- Blood sampling
- Keywords
- Luteinizing hormone, Puberty
- Medical subject headings
- Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Blood sampling for later hormone measurements
| Study group | Role | What they receive |
|---|---|---|
| Hyperandrogenemic | Girls with elevated free testosterone concentrations Receives: Other: Blood sampling | |
| Controls | Girls with normal free testosterone concentrations Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Luteinizing hormone pulse frequency (while awake and while asleep)
Measured: Baseline (time zero)
Secondary outcomes (5)
Progesterone concentration
Measured: Baseline (time zero)
Estradiol concentration
Measured: Baseline (time zero)
Testosterone concentrations
Measured: Baseline (time zero)
Luteinizing hormone amplitude
Measured: Baseline (time zero)
Sleep stage parameters
Measured: Baseline (time zero)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startOct 2008
- Primary completionMay 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperandrogenismStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 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)
- Responsible party
- Principal investigator, Chris McCartney, University of Virginia
- Investigators
- Christopher R McCartney, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930007
- Sponsor's protocol ID
- 13950
- Acronym
- CRM005
- Status last verified
- May 2022
- First submitted
- 24 Jun 2009
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do not have current plans to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sleep-wake LH Frequency in Peripubertal Girls With and Without Hyperandrogenemia
- ClinicalTrials.gov ID
- NCT00930007
- Acronym / sponsor ID
- CRM005 / 13950
- Conditions
- Hyperandrogenism
- Keywords
- Luteinizing hormone, Puberty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Oct 2008
- Primary completion
- May 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 30 Jun 2009 (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 purpose of this study is to determine whether sleep-wake changes of luteinizing hormone pulse frequency are different in early pubertal girls with high testosterone levels compared to early pubertal girls with normal testosterone levels.
Detailed description
During early puberty, luteinizing hormone (LH) pulse frequency normally increases during sleep. In contrast, preliminary data suggest that obese girls (who have high testosterone levels in general) demonstrate low LH frequency during the day and night during early puberty; but at mid puberty rapidly transition to a high LH frequency during the day and night. We hypothesize that in early pubertal girls with high testosterone levels, overnight increases of LH frequency are less prominent than those observed in early pubertal girls with normal testosterone levels. We will assess this using a frequent sampling protocol for assessment of LH pulse frequency (with sampling occurring while awake and while asleep) in early pubertal girls with and without high testosterone levels. Sleep will be formally evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperandrogenemic | – | Other: Blood samplingGirls with elevated free testosterone concentrations |
| Controls | – | Other: Blood samplingGirls with normal free testosterone concentrations |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Community sample and patients from local clinics
Key inclusion criteria (3 listed)
- Early to midpubertal girls (late Tanner 1 [i.e., estradiol > 20 pg/ml] to Tanner 3)
- Premenarcheal
- Approximate ages, 8-15 years
Key exclusion criteria (24 listed)
- BMI-for-age < 5th percentile
- Inability to comprehend what will be done during the study or why it will be done
- Being a study of GnRH pulse regulation in adolescent girls with and without HA, boys are excluded
- Obesity associated with a diagnosed (genetic) syndrome (e.g., Prader-Willi syndrome, leptin deficiency), obesity related to medications (e.g., glucocorticoids), etc.
- Pregnancy or lactation
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 |
|---|---|---|
| Blood samplingBlood sampling for later hormone measurements | Other | Controls, Hyperandrogenemic |
Primary outcome
Luteinizing hormone pulse frequency (while awake and while asleep)
Time frame: Baseline (time zero)
5 secondary outcomes
Progesterone concentration
Time frame: Baseline (time zero)
Estradiol concentration
Time frame: Baseline (time zero)
Testosterone concentrations
Time frame: Baseline (time zero)
Luteinizing hormone amplitude
Time frame: Baseline (time zero)
Sleep stage parameters
Time frame: Baseline (time zero)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Undecided. We do not have current plans to share IPD
Related trials for Hyperandrogenism
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Natural History Study of Patients With Excess Androgen
Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP)
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Polycystic Ovary Syndrome in Type 1 Diabetes
Type 1 Diabetes Mellitus, Polycystic Ovary Syndrome (PCOS)
Recruiting
Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)
PCOS (Polycystic Ovary Syndrome), Obese Adolescents
Recruiting
This Study Aims to Evaluate Whether Milamend's Product Could Improve Hormone Balance in Women Who Suffer From Self-reported PCOS Symptoms.
Polycystic Ovarian Syndrome (PCOS)
Not yet recruitingObservational study
Biomarker Panel for PCOS-Associated Liver Steatosis in Adolescent Girls (COMPASS-pedPCOS)
Polycystic Ovary Syndrome (PCOS), Metabolic Dysfunction-Associated Steatotic Liver Disease
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.
Christopher R McCartney, 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?
An observational study of Hyperandrogenism, 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 3 inclusion and 24 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 May 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 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?
Luteinizing hormone pulse frequency (while awake and while asleep) (time frame: Baseline (time zero)). 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 18 May 2022.