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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 a small molecule drug used for contraception. It is being developed by Bayer AG for use as a contraceptive method. The drug is currently in Phase 3 clinical development, meaning it is still investigational and has not yet been approved for marketing.
Skyla is a small molecule drug. Its specific molecular target has not been disclosed in the available information, so the exact mechanism of action is not detailed here. It is being studied for its contraceptive effects.
Skyla is being developed by Bayer AG, a pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate Skyla for contraception.
Skyla is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial for Skyla has been completed, and the drug is being evaluated for use in contraception.
Skyla has one completed Phase 3 clinical trial, identified as NCT01434160, titled 'LCS12 Adolescent Study'. This trial enrolled 304 female participants aged 12 years and older across multiple European countries, including Austria, Belgium, Denmark, Finland, Germany, Netherlands, Norway, and Sweden. The study was uncontrolled and not randomized or double-blinded.
Skyla is the name used in the clinical trial data provided. No alternative names for Skyla have been mentioned in the available information, so it is not known if it is marketed under other names.