The NICHD conducts and supports a variety of clinical research related to puberty and precocious puberty. Select a link below to learn more about these projects.
Featured NICHD Clinical Trials on Puberty
- Safety Extension Study of Lupron Depot in the Treatment of Central Precocious Puberty
This study is investigating whether leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with central precocious puberty over a longer period of time (36 months).
- Kisspeptin in the Evaluation of Delayed Puberty
The researchers will work with boys (ages 14 to 17) and girls (ages 13 to 17) who have a diagnosis of delayed puberty. The teens will receive two investigational, naturally occurring hormones, kisspeptin and gonadotropin-releasing hormone (GnRH), during two outpatient visits and two brief hospital admissions. The subjects will then be followed every 6 months until they reach 18 years of age to determine whether their pubertal delay was self-resolved or permanent.
- A Longitudinal Investigation of the Endocrine and Neurobiologic Events Accompanying Puberty
The study will examine a group of boys and girls at 8- to 10-month intervals from age 8 (pre-puberty) until age 17 (post-puberty) to see what changes occur in terms of brain structure and function, behavior, and stress responsivity. Researchers will evaluate the youths using brain imaging, genetic testing, and measures of cognition, behavior, physical development, and endocrine and metabolic activity.
- Faslod
- ex in McCune Albright Syndrome (FMAS)
This investigation is designed to evaluate the safety, effectiveness, and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (early puberty) in girls with McCune-Albright syndrome.
- Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls
Working with a population of girls who exhibit suspicious clinical features of precocious puberty, this study is exploring the specificity, sensitivity, and diagnostic efficiency of the triptorelin test in the assessment of central precocious puberty (CPP) compared to the GnRH test, which is considered the gold standard but is not available in all countries.
- The COPENHAGEN Puberty Study Providing Normative Data of Healthy Danish Children and Adolescents
Through clinical examinations and blood analyses from a large number of healthy Danish children, this study will reveal if the age of pubertal onset is declining. Moreover, the extensive data will provide detailed insight into normal ranges and individual changes of anthropometrics (the dimensions and abilities of the human body) and hormone levels in healthy children during childhood and adolescence.
- Natural History Study of Patients With Excess Androgen
The researchers will evaluate and gather information on patients with genetically caused excess androgen (male-like hormone) in order to better understand the effects of too much androgen and subsequently describe problems associated with it.
- Investigation of the Genetic Causes of Kallmann Syndrome and Reproductive Disorders
The aims of this study are (1) to identify genes that play a role in human pubertal development and reproduction; (2) to characterize the phenotypic spectrum of patients with these gene defects; and (3) to discern the mode of inheritance for disorders (Kallmann syndrome, idiopathic hypogonadotropic hypogonadism, precocious puberty, and delayed puberty) caused by these gene defects.
- Gonadotropin Levels in Puberty and Fertility
The investigators will study disorders of GnRH production in adult men and women at least 18 years of age with low or no gonadotropin levels and in adolescents between 14 and 18 years of age with low or no gonadotropin levels.
- Suppression of Daytime and Nighttime Luteinizing Hormone Frequency by Progesterone in Early Pubertal Girls With and Without Hyperandrogenemia
In this study, the investigators aim to discover whether giving three small doses of progesterone to pubertal girls will prevent the nighttime increase of pulses of luteinizing hormone. 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, they may be able to better understand abnormalities of puberty.
NICHD Clinical Trials
ClinicalTrials.gov Search Results
Information on current NIH-sponsored clinical trials on puberty is available at the link below
or by calling 1-800-411-1222.