Clinical trials: Precocious Puberty
Genetic Disorder, Infertility
Inherited Reproductive Disorders
Background: During puberty, children begin to develop into adults. Problems with the hormones released during puberty can affect the reproductive system. Some people have low hormone levels that severely delay or prevent puberty.
- Conditions
- Genetic Disorder, Infertility, Hypogonadism, Amenorrhea
- Trial name
- NCT01500447
- Where
- 2 sites in United States
- Volunteers
- 850 people
- Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
Central Precocious Puberty
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
The primary objective of this study is to evaluate the efficacy of Debio 4326 in suppressing serum luteinizing hormone (LH) to prepubertal levels 52 weeks after the first Debio 4326 injection in pediatric participants with…
- Trial name
- NCT06129539
- Testing
- Debio 4326
- Where
- 17 sites in United States, Argentina and 3 more
- Volunteers
- 56 people
- Sponsor
- Debiopharm International SA
Precocious Puberty, Gonadotropin-dependent
(Z)-Endoxifen in Girls With MAS-Associated Peripheral Precocious Puberty
The goal of this clinical trial is to evaluate the safety, tolerability, and blood levels of (Z)-endoxifen in girls with McCune-Albright Syndrome that have peripheral precocious puberty.
- Trial name
- NCT07869732
- Testing
- (Z)-endoxifen
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Atossa Therapeutics, Inc.
Precocious Puberty, Central
Basal LH Threshold for the Diagnosis of Central Precocious Puberty
This retrospective monocentric observational study aims to evaluate whether basal luteinizing hormone (LH) levels can reliably diagnose central precocious puberty and reduce the need for LHRH stimulation testing.
- Trial name
- CPP-LH (NCT07864116)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Strasbourg, France
Precocious Puberty, Central, Delayed Puberty
INSL3 as a Biomarker of Pubertal Activation: Role in Evaluating Precocious and Delayed Puberty
This is an observational study in children up to 16 years old who are suspected of having central precocious puberty or delayed puberty.
- Trial name
- INSL3GNRH (NCT07859787)
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Hypogonadism, Hypergonadism
Observation of Environment and Reproductive-Endocrine Effects
Background: Endocrine disorders occur when the glands that make hormones do not work properly. Hormones levels that are too high or too low can cause problems such as late or early puberty, irregular periods, and infertility.
- Conditions
- Hypogonadism, Hypergonadism, Precocious Puberty, Late Puberty
- Trial name
- NCT06280807
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP)
Natural History Study of Patients With Excess Androgen
This study will evaluate and gather information in patients with genetic causes of too much androgen (male-like hormone) in order to better understand the effects of too much androgen and describe problems associated with it.
- Trial name
- NCT00250159
- Where
- 2 sites in United States
- Volunteers
- 3,000 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Central Precocious Puberty
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty
The main aim is to see how leuprolide works to treat central precocious puberty in children. Participants will receive an injection of leuprorelin acetate depot 11.25 mg every 12 weeks during 6 months and will visit their study…
- Trial name
- PUPIL (NCT05341115)
- Testing
- Leuprorelin Acetate Depot 3M
- Where
- 5 sites in China
- Volunteers
- 79 people
- Sponsor
- Takeda
Precocious Puberty, Central, Executive Dysfunction
Hypiend - Multicomponent Behavioral Intervention in Pre-puberal Children (Hypiend-PPC)
This study is part of the European Hypiend project, which aims to explore the effects of co-exposure to endocrine-disrupting chemicals (EDCs) on the function and epigenetic programming of the hypothalamic-pituitary-adrenal (HPA)…
- Trial name
- Hypiend-PPC (NCT07411001)
- Testing
- Multi-Component Behavioral intervention, Information
- Where
- Belgium
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Sciensano
Central Precocious Puberty
A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious Puberty
A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children with Central Precocious Puberty
- Trial name
- NCT07710430
- Testing
- Leuprorelin
- Where
- South Korea
- Volunteers
- 43 people
- Sponsor
- LG Chem
Puberty; Precocious, Central
Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with central (gonadotropin-dependent) precocious puberty, when administered as two injections six months apart.
- Trial name
- NCT05493709
- Testing
- Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide
- Where
- 41 sites in United States, China and 2 more
- Volunteers
- 94 people
- Sponsor
- Foresee Pharmaceuticals Co., Ltd.
Puberty, Precocious
Research of Integrated Traditional Chinese and Western Medicine on Precocious Puberty
Precocious puberty is characterized by the premature appearance of secondary sexual characteristics. Globally, the timing of puberty onset in children has shown a certain tendency to advance.
- Trial name
- NCT07325903
- Testing
- administered "Mulberry and Lotus Leaf Heat-Clearing Granules," with the following drug composition: mulberry leaves, lotus leaves, fresh rehmannia, anemarrhena, scutellaria, atractylodes, etc.
- Where
- China
- Sponsor
- Children's Hospital of Fudan University
Precocious Puberty
Clinical Study of Traditional Chinese Medicine in the Treatment of Phlegm-dampness Intrinsic Precocious Puberty
Precocious puberty is characterized by the premature appearance of secondary sexual characteristics. Globally, the timing of puberty onset in children has shown a certain tendency to advance.
- Trial name
- SHJG-PP (NCT07637019)
- Testing
- Sanghe Jianghuo Granules
- Where
- 5 sites in China
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Fudan University
Precocious Puberty
Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type
Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type
- Trial name
- NCT07141615
- Testing
- Qingwei Huazhuo Decoction: Mulberry leaf powder, lotus leaf powder, malt powder, hawthorn powder, Poria cocos powder, gardenia powder, dried tangerine peel powder, licorice powder, momordica grosvenor, diet and exercise education
- Where
- China
- Volunteers
- 94 people
- Sponsor
- Children's Hospital of Fudan University
Puberty, Precocious, Breast
Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context
Various studies show an increase in the number of cases of early puberty in girls with breast development with a variable clinical presentation and evolution. This increasing phenomenon concerns girls between 6 and 8 years old.
- Conditions
- Puberty, Precocious, Breast, Environmental Exposure
- Trial name
- PENELOPE (NCT06083415)
- Testing
- Environmental health measures
- Where
- 2 sites in France
- Volunteers
- 62 people
- Sponsor
- Lille Catholic University
Precocious Puberty, Treatment
A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty
A randomized controlled study will be conducted to evaluate the therapeutic effect of traditional Chinese medicine and acupoints stimulation on children with idiopathic precocious puberty.
- Conditions
- Precocious Puberty, Treatment, Alternative Medicine, Acupuncture
- Trial name
- NCT06510764
- Testing
- intradermal needles, Ziyinxiehuo Granules of traditional Chinese Medicine
- Where
- 2 sites in China
- Volunteers
- 170 people
- Sponsor
- Children's Hospital of Fudan University
Central Precocious Puberty (CPP)
Idiopathic Central Precocious Puberty and Associated Neurodevelopmental Syndromes and Pathologies: Evaluation of Frequency and Comparison of Diagnostic and Developmental Characteristics
Observational, retrosopective, single-centre, non-profit study focused on the frequency of Central Precocious Puberty idiopathic, or associated to Neurodevelopmental Syndromes and Pathologies, and comparison of diagnostic and…
- Trial name
- NCT06720844
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Silver Russell Syndrome, Beckwith-Wiedemann Syndrome
IDMet (RaDiCo Cohort) (RaDiCo-IDMet)
The goal of this observational study is to describe the natural history of imprinting disorders (IDs) according to their metabolic profile in all patients (adults and children) affected with an ID regardless of the severity of…
- Conditions
- Silver Russell Syndrome, Beckwith-Wiedemann Syndrome, Transient Neonatal Diabetes Mellitus, Angelman Syndrome
- Trial name
- IDMet (NCT05945576)
- Where
- 20 sites in France
- Volunteers
- 2,000 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Central Precocious Puberty (CPP), Puberty Disorders
Spexin and Phoenixin-20 in Girls With Central Precocious Puberty
Central precocious puberty (CPP) is characterized by the early activation of the hypothalamic-pituitary-gonadal axis in girls and may be difficult to distinguish from benign variants such as premature thelarche.
- Conditions
- Central Precocious Puberty (CPP), Puberty Disorders, Puberty, Hypothalamic-Pituitary-Ovarian Axis Dysfunction (Disorder)
- Trial name
- SPX-PNX-CPP-20 (NCT07359092)
- Where
- Turkey (Türkiye)
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Kayseri City Hospital
Central Precocious Puberty
A Study of Medical Records From Children With Central Precocious Puberty (CPP) in China
The main purpose is to describe how many children were treated during 24 months or less because of CPP and how treatment worked for them.
- Trial name
- PACTURE (NCT05341128)
- Where
- 5 sites in China
- Volunteers
- 1,477 people
- Sponsor
- Takeda