Clinical trials: Precocious Puberty
Precocious, Leuprolide Acetate
Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty
The purpose of this extension study is to determine if 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).
- Conditions
- Precocious, Leuprolide Acetate, Luteinizing Hormone (LH), Gonadotrophin-releasing Hormone Agonist (GnRHa)
- Trial name
- NCT00667446
- Testing
- Leuprolide Acetate 3 Month Depot
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 72 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
CPP
Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty
This study is a multicenter, open-label, single-group, and phase 4 study to evaluate the efficacy and safety of 45 mg of leuprolide acetate in CPP.
- Trial name
- NEST (NCT06926933)
- Testing
- Eligard® 45 mg
- Where
- 9 sites in South Korea
- Volunteers
- 50 people
- Sponsor
- HanAll BioPharma Co., Ltd.
Central Precocious Puberty
A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants
The purpose of this study is to assess long-term safety and efficacy of leuprorelin in the treatment of Central Precocious Puberty (CPP).
- Trial name
- NCT02427958
- Testing
- Leuprorelin
- Where
- 9 sites in China
- Volunteers
- 307 people
- Sponsor
- Takeda
Idiopathic Precocious Puberty
Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
Our study used a randomized controlled trial to validate the clinical efficacy of a combination of traditional Chinese and Western medicine in the treatment of children with rapid progressive central precocious puberty.
- Trial name
- NCT03963752
- Testing
- Ziyinxiehuo Granules Herbs, Megestrol Acetate Tablet, Leuprorelin Acetate 3.75mg Injection
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Children's Hospital of Fudan University
Central Precocious Puberty
Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty
This is a prospective, multicentric, comparative, non-randomized interventional study in which subjects diagnosed with central precocious puberty (CPP) and early puberty (EP) were treated for 6 months to compare the effect with…
- Trial name
- NCT02920515
- Testing
- Triptorlin or Leuprorelin, Zhibo dihuang pills, Dabu ying pills
- Volunteers
- 740 people
- Sponsor
- Ruijin Hospital
Central Precocious Puberty
A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.
The purpose of the protocol is to assess the efficacy of the triptorelin 6 month PR (Prolonged Release) formulation in suppressing LH (Luteinising hormone) levels to prepubertal levels (defined as a peak LH ≤5 IU/L) after i.v.
- Trial name
- NCT05029622
- Testing
- Triptorelin Pamoate
- Where
- 14 sites in China
- Volunteers
- 66 people
- Sponsor
- Ipsen
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
Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children
The goal of CPP-EDG 01 study is to assess possible genetic and/or environmental parameters which may influence the growth rate of children affected by precocious puberty.
- Trial name
- CPP-EDG 01 (NCT00438217)
- Testing
- Triptorelin (GnRH agonists), Leuprolide (GnRH agonists)
- Where
- Italy
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Pisa
Puberty, Precocious, McCune-Albright Syndrome
Faslodex in McCune-Albright Syndrome
The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (PPP) (early puberty) in girls with…
- Trial name
- FMAS (NCT00278915)
- Testing
- Fulvestrant
- Where
- 16 sites in United States, France and 4 more
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
Central Precocious Puberty
Markers of Pubertal Suppression During Therapy for Precocious Puberty
The best way to measure whether treatment of children with central precocious puberty is working is to do a hormone stimulation test (leuprolide stimulation test) that requires injection of a medication and multiple blood draws…
- Trial name
- NCT02006680
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- University of Minnesota
Precocious Puberty
Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
The purpose of the study is to assess the efficacy of triptorelin 11.25 mg pamoate in the delay of premature onset of puberty in girls less than 9 years and boys less than 10 years.
- Trial name
- DECAPUB (NCT00564850)
- Testing
- Triptorelin pamoate 11.25mg (Decapeptyl® SR)
- Where
- 18 sites in France
- Volunteers
- 37 people
- Sponsor
- Ipsen
Central Precocious Puberty
Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty
The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty.
- Trial name
- NCT01467882
- Testing
- Triptorelin
- Where
- 13 sites in United States, Chile and 1 more
- Volunteers
- 44 people
- Sponsor
- Debiopharm International SA
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
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
Central Precocious Puberty
Efficacy, Metabolism and BMD of the 3-month TP Compared to the 1-month TP in ICPP
The primary objective of this study is to compare the efficacy of the 3-month formulation and 1-month formulation of triptorelin and to assess the short-term effects of the 3-month formulation of triptorelin on glucose and lipid…
- Trial name
- NCT06487143
- Testing
- Triptorelin pamoate（15mg）, Triptorelin acetate （3.75mg）
- Where
- China
- Volunteers
- 134 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
McCune-Albright Syndrome
Arimidex in McCune Albright Syndrome
The primary objective of this study is to evaluate the safety and efficacy of anastrozole 1 mg given once daily in subjects with McCune-Albright Syndrome.
- Trial name
- NCT00055302
- Testing
- Arimidex 1 mg
- Where
- 7 sites in France, Germany and 2 more
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
McCune Albright Syndrome, Polyostotic Fibrous Dysplasia
Effects of Letrozole on Precocious Puberty Due to McCune Albright Syndrome
This study will test the safety and effectiveness of letrozole in treating precocious (early) puberty in girls with McCune-Albright syndrome (MAS).
- Conditions
- McCune Albright Syndrome, Polyostotic Fibrous Dysplasia, Precocious Puberty
- Trial name
- NCT00006174
- Testing
- Letrozole
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
Delayed Puberty, Precocious Puberty
Follicle-Stimulating Hormone (FSH) and the Onset of Puberty
The purpose of this study is to determine if the timing of the onset of puberty may be affected by FSH-regulatory peptides. We will determine how these peptides relate to FSH production in prepubertal and pubertal children by…
- Trial name
- NCT00734279
- Testing
- Leuprolide Acetate - Early Puberty Leuprolide Visit, Ganirelix - Early Puberty Ganirelix Visit, Ganirelix - Delayed Puberty Ganirelix Visit
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- University of Utah
Hypogonadism, Precocious Puberty
Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle
OBJECTIVES: I. Evaluate the sleep-entrained patterns of gonadotropin-releasing hormone (GnRH) and sex steroid secretion in normal and hypogonadal children. II.
- Trial name
- NCT00004335
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Center for Research Resources (NCRR)
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