Assessment of Day-night Secretion of Progesterone and LH Across Puberty (NCT02155933) | Clinical Trial Compass
UnknownNot Applicable
Assessment of Day-night Secretion of Progesterone and LH Across Puberty
United States75 participantsStarted 2008-07-10
Plain-language summary
Hormones are substances that are made by the body and are sent directly out into the bloodstream to increase or decrease the function of certain organs, glands, or other hormones. Testosterone is a hormone found in the blood of all girls, but some girls have too much testosterone in their blood. Too much testosterone in the blood can possibly lead to a problem called polycystic ovary syndrome (PCOS). People with PCOS have abnormal menstrual periods, excess facial and body hair, and too much testosterone in their blood. On the other hand, some girls with too much testosterone in their blood do not develop PCOS. We do not know why some of these girls develop PCOS and why some do not. The purpose of this research study is to find out whether too much testosterone can cause problems with other hormones that can lead to the development of PCOS. This study may help us understand more about the causes of PCOS.
Who can participate
Age range
7 Years – 17 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Early and late pubertal girls with normal androgens
* Early and late pubertal girls with hyperandrogenemia
* All subjects will be girls from pre-puberty (Stage 1 breast development and pubic hair growth but at least 7 years old) to 7 years post menarche.
Exclusion Criteria:
* Pregnancy
* Inability to comprehend what will be done during the study or why it will be done
* Hemoglobin \<11.5 g/dL for non-African American subjects; Hemoglobin \< 11.0 g/dL for African American subjects
* Persistently abnormal sodium, potassium, or bicarbonate (i.e., confirmed on repeat)
* Persistently elevated creatinine, hepatic transaminases, or alkaline phosphatase (i.e., confirmed on repeat)
* Total bilirubin \> 1.5 times upper limit of normal (i.e., confirmed on repeat)
* Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
* Untreated hypo- or hyperthyroidism (reflected by persistently abnormal TSH values)
* Total testosterone \> 200 ng/dl
* Basal (follicular) 17-OHP \> 200 ng/ml (in girls without a previous diagnosis of congenital adrenal hyperplasia)
* DHEA-S \> 800 mcg/dl
* Elevation of prolactin \> 2 times upper limit of normal
* Weight less than 25 kg
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in mean LH frequency when awake (19:00-23:00 and 07:00-11:00) and when asleep (23:00-07:00) in girls with and without hyperandrogenemia
Timeframe: Time frame for the study will be 18 hours (Sampling begins at 1800 hrs and proceeds through 1200 hours the following day).