Regulatory Decision Summary for Jaydess

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Medicinal ingredient(s):

levonorgestrel

Therapeutic area:

Sex Hormones And Modulators of the Genital System

Type of submission:

Supplement to a New Drug Submission

Control number:

204355
What was the purpose of this submission?

 

This supplemental new drug submission (SNDS) was filed to expand the indication to include post-menarcheal adolescents under the age 18 based on results from a study of Jaydess (LCS12) in adolescent females.

 

Why was the decision issued?

 

This current submission includes revision of Indications and Clinical Use section (Pediatrics <18 years of age), to include; post-menarcheal adolescents under the age of 18. The changes were supported by one pivotal study in post-menarcheal adolescents up to 18 years of age to assess the safety of Jaydess in adolescents. The primary objective being the incidence of adverse events (AEs). The secondary objectives of the study were to evaluate contraceptive efficacy (Pearl Index), bleeding pattern, insertion and removal procedures (pain and ease), discontinuation rate and pharmacokinetics in adolescents.

The trial demonstrated higher compliance when compared to oral contraceptive use in adolescents. Contraceptive efficacy (no pregnancies occurred in the first year of treatment and 2 pregnancies during the 2-year extension phase) with an overall PI of 0.34 (95% CI: 0.04 to 1.23) was also demonstrated. The bleeding pattern was favorable and the number of bleeding days was reduced over time. There was low systemic exposure to levonorgestrel due to low dosage contained in the device leading to low incidence of systemic side effects, and easy insertion due to small diameter of insertion tube. Adolescents may be less tolerant of insertion pain than adults.

The risks identified are consistent with the known profile of the product. These risks are addressed in the product monograph and include ectopic pregnancy, pelvic inflammatory disease, isolated cases of decreased milk production, uterine perforation or penetration of the uterine corpus or cervix, partial expulsion complete expulsion of the device and possible development of ovarian cysts. This product does not protect against sexually transmitted diseases.

As the benefit risk profile of including post-menarcheal adolescents under the age of 18 is found to be favorable, the submission was issued a Notice of Compliance.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.