Precocious Puberty

Researchers are evaluating the safety and effectiveness of a monthly Leuprorelin treatment given for 24 months in children diagnosed with central precocious puberty CPP. This phase 4, single-arm, open-label study focuses on children with early puberty signs, primarily girls younger than 9 years and boys younger than 10 years, who have reached Tanner stage 2 or higher. The study aims to understand how this treatment impacts hormone levels and puberty progression over two years. Participants will receive Leuprorelin injections every four weeks for up to 24 months. This treatment is designed to influence hormone levels by suppressing luteinizing hormone LH after stimulation with gonadotropin-releasing hormone GnRH. The study tracks changes in hormone levels, pubertal development, growth parameters like height and weight, and monitors for any treatment-related adverse events during this period. During the trial, children will undergo regular assessments including hormone tests to measure LH, follicle-stimulating hormone FSH, testosterone, and estradiol levels, as well as evaluations of their pubertal stage and growth. Safety is closely monitored by recording any side effects related to the treatment. The primary outcome is the suppression of peak LH levels 24 weeks after starting treatment, with ongoing follow-ups up to 96 weeks to observe longer-term effects and safety.

Researchers are evaluating the effects of traditional Chinese medicine combined with intradermal acupuncture on girls with idiopathic precocious puberty, a condition characterized by early onset of puberty without an identifiable cause. This phase 3 randomized controlled trial aims to determine if combining acupuncture point stimulation with herbal treatment can improve symptoms and prevent the condition from worsening. The study focuses on girls with mild to moderate precocious puberty and explores whether this combined approach offers benefits beyond traditional herbal medicine alone. Participants will be randomly assigned to one of two groups. One group will receive Ziyin-Xiehuo traditional Chinese medicine granules twice daily along with intradermal acupuncture point stimulation targeting specific points, applied three times daily with needles changed every two days, for a duration of six months. The other group will receive only the traditional Chinese medicine granules twice daily for the same six-month period. This design allows comparison between combined therapy and herbal medicine alone. During the study, researchers will monitor participants breast development changes, particularly the reduction or disappearance of mammary nucleus size at three months. They will also assess bone age changes compared to chronological age over six months. Various evaluations such as ultrasound measurements of uterus and ovary size, Tanner staging, and hormone treatment history will be collected. Safety and efficacy will be carefully observed throughout the six-month treatment period.

Researchers are investigating how a physical activity program affects hormone health and diabetes risk in girls aged 8 to 12 who may be at higher risk for conditions like Polycystic Ovary Syndrome PCOS and insulin resistance. This pilot randomized trial aims to evaluate whether the ActiveGirls program effectively engages girls and their families to increase physical activity and to track changes in markers of diabetes risk and puberty hormones over one year. Participants are randomly assigned to either a full intensity intervention group or a delayed lower intensity comparison group. The full intensity group receives 3-4 educational messages per week via text or email and six health coaching visits via telemedicine during the first six months. The delayed lower intensity group receives only the educational messages during months 7 to 12. Both groups complete at-home activity monitoring and participate in study visits for health assessments. Participants will have baseline and 12-month in-person visits at the research center, with a remote assessment at 6 months. These visits include checks on body composition, insulin sensitivity, reproductive hormones, and physical fitness. Surveys about lifestyle behaviors and social-emotional wellness are completed by both participants and a caregiver. The study measures retention, acceptability, physical activity levels, insulin sensitivity changes, and hormone levels over the year-long participation period.

Researchers are investigating how progesterone affects luteinizing hormone LH pulse frequency during waking and sleep periods in mid- to late pubertal girls, both with and without hyperandrogenism HA. The study aims to find out if progesterone reduces waking LH pulse frequency more than sleep-associated LH pulse frequency in girls without HA, and whether this effect is less in girls with HA. The study is a randomized, placebo-controlled, double-blind crossover trial involving mid- to late pubertal girls at Tanner breast stage 3 or higher but no more than 2 years after menarche. Participants will attend two 18-hour clinical research unit admissions across separate menstrual cycles, receiving either oral micronized progesterone 0.8 mgkg at 7 AM, 3 PM, 11 PM, and 7 AM or placebo. Blood samples will be collected every 10 minutes overnight to measure LH pulses and other hormones. After at least two months, participants will switch treatments for the second admission. Participants will be closely monitored throughout the study with frequent blood tests to characterize LH secretion patterns. The main measure is LH pulse frequency while awake, with sleep LH pulse frequency as a secondary measure. The study includes detailed hormone analysis and statistical modeling to compare effects between girls with and without HA. The total participation includes two inpatient admissions separated by at least two months.

Researchers are collecting long-term data from children, teenagers, and adult family members who have known or suspected gynecologic conditions related to the reproductive system. These conditions include reproductive gland disorders, tumors, and congenital anomalies. The study aims to create a large database to improve understanding of pediatric and adolescent gynecologic PAG disorders. Participants will receive standard clinical care and will not be given experimental drugs or treatments as part of this observational study. Researchers will review medical records, conduct medical histories and physical exams, and collect biological samples such as blood, saliva, and optional vaginal swabs for genetic and other research tests. If participants undergo related surgery, tissue samples may also be collected for future study. Optional surveys about physical and emotional health may be completed. Throughout the study, researchers will gather medical data from routine tests like blood and urine tests, scans, and other clinical procedures. Participants health and medical information will be monitored over time to build a comprehensive database of PAG conditions. The study is ongoing and participants may be followed for extended periods to help improve knowledge about these conditions.

Researchers are evaluating whether spironolactone, an androgen-receptor blocker, can normalize sleep-wake luteinizing hormone LH pulse frequency in mid- to late pubertal girls with hyperandrogenism. The study focuses on adolescent girls aged 10 to 17 who have elevated free testosterone levels or clinical signs of excess androgens. This early phase 1 trial aims to understand how spironolactone affects hormone secretion patterns during sleep and wakefulness in this group. The study uses a randomized, placebo-controlled, double-blinded crossover design. Participants receive either spironolactone 50 mg twice daily or a placebo for two weeks before each of two clinical research unit admissions, spaced at least four weeks apart. During admissions, blood samples are taken every 10 minutes from late afternoon to early morning to measure pulsatile LH secretion, and polysomnography is performed to monitor sleep stages. Participants switch treatments between admissions to compare effects. During the study, participants will undergo close monitoring including frequent blood draws and sleep studies. Researchers will measure changes in sleep-associated and wake-associated LH pulse frequencies and analyze how REM sleep influences LH pulse initiation with and without spironolactone. The primary outcome is the change in sleep-associated LH pulse frequency over about two months. Safety and hormone levels will be carefully observed throughout the trial period.

Researchers are studying early breast development in girls aged 6 to 8 years, a phenomenon that has been increasing and is often without a clear medical cause. This trial aims to analyze many factors, including body fat, metabolism, exposure to endocrine disruptors, and epigenetic changes. The study also explores how environmental health measures might influence these factors and uses experimental models to test related biological hypotheses. The study involves two groups girls aged 6 to 8 years with signs of breast development who are scheduled for pediatric day hospital care, and control girls of the same age without signs of puberty undergoing routine consultations or MRI scans for other reasons. Participants will have breast, ovary, uterus sizes, and abdominal fat measured by MRI at the start and after three months. Various biological and metabolic markers will be tested through blood, urine, and hair samples, and dental photographs will assess tooth mineralization. Participants will be followed over six months with measurements of growth, body mass index, and hormone levels at regular intervals. Assessments include MRI scans, bone age X-rays, and hormone tests at baseline, three months, and six months. The study monitors changes in breast development, fat distribution, and related biological markers to understand the impact of environmental factors and health measures on early puberty progression.

Researchers are studying the early and advanced onset of puberty in children, focusing on the increasing age of puberty signs observed in the United States and Europe. This observational study aims to understand the causes behind these changes, including environmental endocrine disruptors and nutritional factors, by establishing a national observatory in collaboration with pediatric endocrinologists. The study targets children experiencing early signs of puberty to supplement existing epidemiological data that is currently limited. The study includes three groups based on puberty development children with suspected precocious puberty girls under 8 years, boys under 9 years, children with suspected advanced puberty girls 8 to under 10 years, boys 9 to under 11 years, and a control group of children without signs of puberty development Tanner stage 1. Participants are seen by pediatric endocrinologists during consultations, and their data is collected over a period of up to 48 months. Participants will be involved through consultations where data on their pubertal development is gathered. Researchers will monitor the number of patients recruited, the completeness of collected data, and the inclusion rate of eligible patients. The study plans to reach at least 75% patient inclusion and collect at least 80% of the main data during the observation period. The total study duration extends up to 48 months, allowing thorough follow-up and data analysis to better understand puberty timing changes.

Researchers are investigating the genetic causes of reproductive disorders such as hypogonadotropic hypogonadism and Kallmann syndrome, as well as cleft lip andor palate. These conditions affect puberty, sexual maturation, and fertility, and may share genetic links. The study aims to deepen understanding of the genetic control of puberty and reproduction, and how these relate to cleft lip and palate, with hopes to improve diagnosis, treatment, and counseling for affected individuals and families. Participants with reproductive disorders, with or without cleft lippalate, and their family members will be enrolled. Patients will complete medical questionnaires, provide family history, and have various specimens collected including blood, saliva, urine, hair follicles, sperm, or skin biopsies. They will also undergo tests such as smell and hearing assessments, bone density scans, brain MRI, and ultrasounds of kidney and reproductive organs. Family members will also provide questionnaires, samples, and undergo smell testing. During the study, researchers will analyze genetic variants and their function, inheritance patterns, and how these relate to physical traits. The main outcome is identifying rare genetic sequence variants. Participants will be monitored for about one year following variant identification. The study includes ongoing assessments of family history, clinical features, and biological samples to better understand these inherited conditions and their impact.

Researchers are evaluating whether blocking androgen receptors with spironolactone improves progesterones ability to reduce waking luteinizing hormone LH pulse frequency in mid- to late pubertal girls with hyperandrogenism. This randomized, placebo-controlled, double-blinded crossover study focuses on girls who are candidates for spironolactone treatment. The study aims to understand hormonal changes related to hyperandrogenism during puberty. Participants will receive two weeks of pretreatment with either spironolactone 50 mg twice daily or a placebo before each of two 18-hour Clinical Research Unit admissions, which occur in separate menstrual cycles at least two months apart. During admissions, oral micronized progesterone will be administered four times daily at specified times. Blood samples will be collected every 10 minutes overnight to assess LH pulse frequency and other hormone levels. Polysomnography will be done to monitor sleep during admissions. Girls will undergo detailed hormone monitoring during both admissions, with researchers measuring LH pulse frequency while awake as the primary outcome. Secondary measures include LH pulse frequency during sleep. The study includes assessments of hormone levels, sleep patterns, and safety monitoring. Participants will be closely observed throughout the study to evaluate the hormonal effects of spironolactone compared to placebo in response to progesterone. Total participation spans multiple menstrual cycles with careful crossover between treatments.