Precocious Puberty Clinical Trial
Official title:
Follow-up of Girls With Premature Thelarche and Precocious Puberty: a Clinical and Paraclinical Study of Girls With Thelarche and Healthy Controls
Precocious puberty - the onset of signs of puberty before 8 years of age in girls - is be physically and emotionally devastating for kids and is sometimes caused by an underlying and medical condition. One sign of precocious puberty in small girls is breast development (thelarche). This can persist without other physical changes of puberty, it may continue into precocious puberty, or it may disappear. This project will improve the diagnostics of precocious puberty in girls and improve our ability to identify which girls with thelarche, who will develop precocious puberty and need medical treatment.
The purpose of the study is
1. To conduct an epidemiological study in which characteristics of 0-6 year-old girls with
either premature thelarche or precocious puberty are described (as specified below)
2. To conduct a clinical and para-clinical re-examination of the before-mentioned (1))0-6
year-old girls
3. To compare the clinical and paraclinical parameters in point 1) mentioned 0-6 year-old
girls with a control group of children at the same age, whiteout thelarche and
precocious puberty. (Local Ethics Committee has approved the study of the control
group, case number 1-10-72-631-12.)
The study includes a chart review of registered 0-6 year-old girls diagnosed with premature
thelarche or precocious puberty from 1998 and until today at Dept. of Pediatrics A, AUH
Skejby. The cohort has not earlier been examined and the number of girls in the cohort is
estimated from our clinical experience with this patient group to be about 50 in total. The
following characteristics from the patients records will be registered in a database:
Age at diagnosis, anthropometry (height and weight), Tanner stage - breast, Tanner stage -
pubic hair, GnRH test (LH and FSH response), thyroid parameters, estrogen, prolactin, 17OHP,
androstenedione, dihydroepiandrosteron (DHEA), testosterone, inhibin B, SHBG, AFP,
kisspeptin, human chorionic gonadotropin (HCG), bone age, MRI of the cerebrum, US of
internal genitalia, and exposures to environmental chemicals known to affect secondary sex
characteristics.
The database will be developed in the program Access. The results will be reported as mean
and standard deviation and minimum and maximum values for each age group by Tanner stage, if
the data are normally distributed. Non-normally distributed data will be given as median and
confidence intervals as well as minimum and maximum values for each Tanner stage. Data for
previously studied children with suspected precocious puberty, will be reported in the same
way. Statistical comparison between the groups will be made with u-paired t-test or
equivalent non-parametric test, if the data is not normally distributed.
The Data Unit at Aarhus University Hospital, Skejby, identifies 0-6 year-old girls with
diagnoses premature thelarche or precocious puberty in 1998 and onwards. Girls below 8 years
of age at baseline of the project (1st of September 2013) will be contacted and requested to
participate in a re-examination.
The follow-up is a clinical and paraclinical re-examination, where the following parameters
are measured: anthropometry (height and weight), skinfold thickness, Tanner stage, bone age,
GnRH test, p-estrogen, p-testosterone , p-SHBG, p- androstenedione, p-dihydroandrostendion,
p-inhibin B, p-thyroid parameters, ultrasound examination of the genitalia interna and a
blood sample for studies of polymorphism in the estrogen receptor gene and aromatase enzyme
gene.
If the girls are unable or unwilling to attend the reexamination, they are requested to fill
out a questionnaire instead as follows:
- name, social security number, date of completion the questionnaire
- current height, current weight, birth weight, origin
- date of onset of puberty if started, current pubertal development, menarche
- diseases/admissions
Regarding the mother:
- age at menarche, medicine during pregnancy/breastfeeding, diet during
pregnancy/breastfeeding, use of cosmetics /cream/shampoo during pregnancy,
Regarding the family:
- others with early breast development/early puberty
The project is conducted at Dept. of Pediatrics A, Aarhus University Hospital, Skejby,
Skejbygårdsvej 100, 8200 Aarhus N. The other pediatric wards in the Region of Midtjylland
(located in Randers, Viborg and Herning) will be included in the project if they prefer to
participate.
;
Observational Model: Case-Only
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT01944488 -
LH Response to GnRH Test in Prepubescent Girls Under 6 Years
|
N/A | |
Completed |
NCT00564850 -
Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
|
Phase 3 | |
Completed |
NCT00001181 -
Testolactone for the Treatment of Girls With LHRH Resistant Precocious Puberty
|
Phase 2 | |
Recruiting |
NCT04113070 -
Overweight and Obesity and Puberty Development Cohort Study
|
||
Recruiting |
NCT01601171 -
Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate
|
||
Completed |
NCT00734279 -
Follicle-Stimulating Hormone (FSH) and the Onset of Puberty
|
Early Phase 1 | |
Recruiting |
NCT05338411 -
Effect of Exogenous Growth Hormone on Ocular Findings
|
||
Recruiting |
NCT06280807 -
Observation of Environment and Reproductive-Endocrine Effects
|
||
Completed |
NCT00004344 -
Purification of Testis-Stimulating Factor in Precocious Puberty
|
N/A | |
Completed |
NCT00001202 -
Treatment of Boys With Precocious Puberty
|
Phase 2 | |
Completed |
NCT04665713 -
Effect of Prevalence of BMI on Efficacy of Herbal Medicines in Girls' Sexual Precocity
|
||
Completed |
NCT02199587 -
The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or GH Provocation Test
|
N/A | |
Terminated |
NCT04502836 -
Evaluation of the Correlation Between Psychological Intervention, Including Providing Knowledge and Tools for Problems Solving, and the Anxiety Level of Female Patients Arriving to ACTH LRH Test - Pilot Study
|
N/A | |
Completed |
NCT00006174 -
Effects of Letrozole on Precocious Puberty Due to McCune Albright Syndrome
|
Phase 1 | |
Completed |
NCT02650141 -
Clinical Trial of Experienced Chinese Herbal Formulas on Different Types of Precocious Puberty
|
N/A | |
Completed |
NCT00909844 -
Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
|
Phase 3 | |
Completed |
NCT00004335 -
Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle
|
N/A |