Kisspeptin in the Evaluation of Delayed Puberty (NCT01438034) | Clinical Trial Compass
CompletedPhase 1
Kisspeptin in the Evaluation of Delayed Puberty
United States24 participantsStarted 2013-06-08
Plain-language summary
The goal of this study is to test whether the hormone kisspeptin has the potential to prospectively diagnose adolescents with self-resolving or permanent delayed puberty. Some children with delayed puberty will eventually enter puberty on their own. However, some children with delayed puberty have a permanent condition and require medical treatment to undergo puberty. Right now, there is no reliable diagnostic tool to tell whether a child's delayed puberty will be self-resolving or permanent. The hormone kisspeptin has the potential to prospectively diagnose adolescents with self-resolving or permanent delayed puberty.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
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:
Adolescent Boys
* ages 13.5-17 years
* testicular volume \<4 mL OR 4-8 ml with no change in the past 6 months by Prader orchidometer
* first morning (before 9AM) LH \<2 mIU/mL and testosterone \<50 ng/dL
Adolescent Girls
* ages 12-17 years
* Tanner stage I OR II breast development with no change in the past 6 months
* first morning (before 9AM) LH \<2 mIU/mL and estradiol \<20 pg/ml
All Subjects:
* bone age less than chronological age
* weight ≥ 28 kg
* body mass index \>10th percentile and \<+3 SDS for bone age
* blood pressure \>5th percentile and \<95th percentile for bone age and height
* white blood cell counts, platelet counts, electrolytes, thyroid stimulating hormone (TSH), free thyroxine (T4) within reference range for age
* erythrocyte sedimentation rate \<2X the upper limit of the reference range for age
* hemoglobin within reference range for girls of the same chronological age
* blood urea nitrogen (BUN), creatinine, prolactin not elevated
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no more than 2X the upper limit of the reference range
* Insulin-like growth factor 1 (IGF-1) within reference range for bone age
Exclusion Criteria:
All Subjects:
* history or presence of underlying condition that could cause delayed puberty (chronic illness, weight loss, abnormal cranial magnetic resonance imaging (MRI))
* history of an allergic drug reaction
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 change in luteinizing hormone (LH) in response to kisspeptin