Puberty and Precocious Puberty: Clinical Trials

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

  • Hormonal Regulation of Puberty and Fertility
    This study will look at the medical histories and hormone levels of adult patients with idiopathic hypogonadotropic hypogonadism, a rare clinical syndrome characterized by decreased gonadotropin-releasing hormone (GnRH). The intent is to increase understanding of the physiology of GnRH secretion.
  • Inherited Reproductive Disorders
    This is a genetic investigation of patients with precocious (early) and delayed puberty, as well as idiopathic hypogonadotropic hypogonadism, combining candidate gene and whole exome approaches with linkage analysis. The goal is better understanding of the mechanisms underlying the reawakening of the hypothalamic-pituitary-gonadal axis at puberty.
  • Progesterone Suppression of Nocturnal LH Increases in Pubertal Girls
    This is a randomized intervention study that gives 25 to 50 mg (based on body weight) progesterone or placebo twice each afternoon/evening to young females aged 9 to 14 years. The purpose is to further understanding of the relationship between progesterone and luteinizing hormone (LH) pulse frequency and amplitude by testing the hypothesis that in early prepubertal girls, LH pulse frequency will be lower in girls receiving progesterone than in those receiving placebo.
  • Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Early Pubertal Girls
    This is a non-randomized, single-arm intervention study that gives girls aged 8 to 14 years oral progesterone three times a day and oral estrace once a day for 7 days. The purpose is to discover the effect of 7 days of estrogen and progesterone on GnRH pulses in order to learn more about how menstrual cycles are normally established in girls during puberty.
  • Sleep-wake Changes of LH Frequency in Pubertal Girls With and Without High Testosterone
    This is an observational study involving multiple blood draws in girls aged 8 to 15 years. Its purpose is to determine if sleep-wake changes in LH pulse frequency in early prepubertal girls with high testosterone levels differ from those in girls with normal testosterone levels.
  • 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 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.
  • Natural History Study of Patients With Excess Androgen
    The researchers will evaluate and gather information on patients with genetically caused excess androgen to better understand the effects of higher levels of androgen and subsequently describe problems associated with them. Androgens are hormones that are generally found in higher levels in males than females.
  • 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 LH 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 LH. 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 by following the link below or by calling 800-411-1222.

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