The Libelula clinical trial will assess a new drug (Debio 4326) for children with central precocious puberty (CPP). Girls and boys with CPP may have social and emotional problems because they feel different from their peers. Hormonal treatment to slow down puberty can last for several years, and the existing injectable treatments need to be taken every 1, 3, or 6 months. In this clinical trial, the study drug will be given once a year.

Your child may be able to take part if they:

• • – are aged 5 to 8 years, inclusive
  • – have CPP
  • – are being treated with gonadotropin-releasing hormone agonist (GnRHa) therapy for minimum a year prior to entering this study

Children of other ages may be able to take part in this clinical trial. When contacting a clinical trial doctor, they will be able to tell you if children under 5 or older than 8 can now take part in the study.

Participation in the study may last for up to 2 years and 4 months and may require a maximum of 21 study visits.

Information on Triptorelin history

The Libelula study drug (Debio 4326) is triptorelin, which belongs to the gonadotropin-releasing hormone agonist (GnRHa) family used as standard of care in Central Precocious Puberty. GnRHa treatment can reduce the level of sex hormones and slow down the progression of puberty and physical development.

The Libelula study drug formulation is designed as an extended-release formulation of triptorelin (12-month formulation) and will be administered as an intramuscular injection. An extended-release formulation means that the drug is slowly released in the body over a prolonged period of time.

With this new formulation, the Libelula Study intends to further reduce the frequency of injections, and consequently the frequency of potential injection-site reactions. Moreover, this formulation will be especially beneficial to children who are diagnosed with CPP very early on in their childhood and require long-term GnRHa treatment to suppress the progression of the precocious puberty.

Debiopharm International has conducted a Phase III trial of triptorelin Definition Triptorelin, the active substance of Decapeptyl®/Trelstar®/Pamorelin®, is a GnRH agonist analogue. An agonist is a chemical that binds to a receptor of a cell and triggers a response by that cell. More info: http://bit.ly/2vO2Px7 22.5 mg 6-month formulation in children with precocious puberty, a hormonal Definition a hormone is a substance produced by a gland that regulates other parts of the body disorder causing early pubertal changes Definition development of pubic hair and breasts and onset of menstrual periods in girls, and increased growth of testicles and penis in boys and accelerates growth speed and maturation of the bones. The purpose of this trial was to show that triptorelin Definition Triptorelin, the active substance of Decapeptyl®/Trelstar®/Pamorelin®, is a GnRH agonist analogue. An agonist is a chemical that binds to a receptor of a cell and triggers a response by that cell. More info: http://bit.ly/2vO2Px7 works and is safe in children with precocious puberty when it is injected by the intramuscular route (i.e. in the muscle) every six months (triptorelin Definition Triptorelin, the active substance of Decapeptyl®/Trelstar®/Pamorelin®, is a GnRH agonist analogue. An agonist is a chemical that binds to a receptor of a cell and triggers a response by that cell. More info: http://bit.ly/2vO2Px7 6-month formulation). The treatment in this study lasted 1 year, each child being injected twice with the triptorelin Definition Triptorelin, the active substance of Decapeptyl®/Trelstar®/Pamorelin®, is a GnRH agonist analogue. An agonist is a chemical that binds to a receptor of a cell and triggers a response by that cell. More info: http://bit.ly/2vO2Px7 6-month formulation. This indication has since been registered in Europe and the submission dossier registration is currently being examined in the US.

Triptorelin has been used for the treatment of precocious puberty since 1986, especially in Europe. The effect of triptorelin Definition Triptorelin, the active substance of Decapeptyl®/Trelstar®/Pamorelin®, is a GnRH agonist analogue. An agonist is a chemical that binds to a receptor of a cell and triggers a response by that cell. More info: http://bit.ly/2vO2Px7 is to reduce the quantity of the hormones in the body responsible for the early pubertal changes described above. In the beginning, triptorelin Definition Triptorelin, the active substance of Decapeptyl®/Trelstar®/Pamorelin®, is a GnRH agonist analogue. An agonist is a chemical that binds to a receptor of a cell and triggers a response by that cell. More info: http://bit.ly/2vO2Px7 was given as injections administered every month or every three months. The triptorelin Definition Triptorelin, the active substance of Decapeptyl®/Trelstar®/Pamorelin®, is a GnRH agonist analogue. An agonist is a chemical that binds to a receptor of a cell and triggers a response by that cell. More info: http://bit.ly/2vO2Px7 preparation that was administered in this recent trial is similar to the triptorelin Definition Triptorelin, the active substance of Decapeptyl®/Trelstar®/Pamorelin®, is a GnRH agonist analogue. An agonist is a chemical that binds to a receptor of a cell and triggers a response by that cell. More info: http://bit.ly/2vO2Px7 injected every month or every three months except that it can be injected every six months. These preparations are all sustained-release formulations produced in such a way that once the drug has been injected, the drug is released in the body continuously over the indicated period.