Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone (NCT01428089) | Clinical Trial Compass
UnknownPhase 1
Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone
United States40 participantsStarted 2011-03-11
Plain-language summary
During childhood, the levels of certain hormones: gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estrogen, and progesterone are very low. However, when puberty starts, GnRH and LH pulses begin to increase, but they initially do so at night only. It is unknown why GnRH and LH pulses increase at night and then decrease during the day (instead of being increased all the time). The purpose of this study is to see how quickly progesterone reduces LH pulses. The study is also meant to find out whether too much testosterone (also a hormone) in the blood causes problems with the ability of progesterone to reduce LH pulses. In this study, the investigators aim to discover whether or not giving 3 small doses of progesterone to pubertal girls will prevent the nighttime increase of LH pulses. From the information gathered in this study, the investigators may be able to learn more about how menstrual cycles are normally established in girls during puberty. Ultimately, if the investigators understand these normal processes, the investigators may be able to better understand abnormalities of puberty.
Who can participate
Age range
7 Years – 14 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:
* Female volunteers in early to mid-puberty (i.e., late Tanner I \[estradiol level \> 20 pg/mL\], Tanner II, or Tanner III)
* Premenarcheal
Exclusion Criteria:
* Pregnancy
* Inability to comprehend what will be done during the study or why it will be done
* Hemoglobin less than 12 g/dl and hematocrit less than 36%
* 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 thyroid-stimulating hormone (TSH) values
* Total testosterone \> 200 ng/dl
* Basal (follicular) 17-hydroxyprogesterone \> 200 ng/ml (in girls without a previous diagnosis of congenital adrenal hyperplasia)
* Dehydroepiandrosterone sulfate (DHEA-S) \> 800 mcg/dl
* Elevation of prolactin \> 2 times upper limit of normal
* Weight less than 26 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
Average luteinizing hormone (LH) interpulse interval and the total number of LH pulses