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Label indication Skyla ® is indicated to prevent pregnancy for up to 3 years. Replace the system after 3 years if continued use is desired. Skyla is a progestin-containing intrauterine system (IUS) indicated for prevention of pregnancy for up to 3 years. ( 1 ) FDA label
Skyla · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Skyla (Levonorgestrel, BAY86-5028) | DRUG | Levonorgestrel intrauterine contraceptive system (LCS12) insertion into the uterus at insertion visit 2 with the study treatment of 12 months. An optional follow up phase up to 3 years will be offered for all subjects completing 12 month treatment time. |
Inclusion Criteria: * The subject has signed and dated the informed consent form (ICF) * The subject is female, generally healthy, post-menarcheal, nulliparous or parous, requiring contraception, and is under 18 years of age at the Screening visit * The subject has regular menstrual cycles without ...
Skyla is used for contraception. It is a small molecule developed by Bayer AG for the endocrine therapeutic area. The clinical program evaluated Skyla in a Phase 3 study in adolescent females, with contraception as the condition under investigation.
Skyla is developed by Bayer AG, which trades under the ticker BAYRY. Bayer AG is the sponsor of the clinical program for Skyla in contraception.
Skyla is in Phase 3 development. The program includes one completed Phase 3 trial, the LCS12 Adolescent Study, which enrolled 304 participants. No active trials are currently listed for Skyla.
Skyla has been studied in the LCS12 Adolescent Study, registered as NCT01434160. This completed Phase 3 trial enrolled 304 female participants aged 12 years and older across Austria, Belgium, Denmark, Finland, Germany, the Netherlands, Norway, and Sweden, and included healthy volunteers.
Yes, Skyla is also known as Levonorgestrel and BAY86-5028. These names refer to the same small molecule developed by Bayer AG for contraception.