Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as LNG-IUS (BAY 86-5028)
LNG-IUS · 2 trials · 2 indications
Measured by using Subject Diaries (Subject Reported Data)
Measured by using Subject Diaries (Subject Reported Data)
Definition of successful treatment: * Completion of HRT phase, and * Both, the number of bleeding days and the number of spotting days during HRT was equal to or less than during contraceptive phase, and * The number of bleeding days and the number of spotting days could be calculated for at least 3 out of the first 4 reference periods in HRT
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | ACTIVE_COMPARATOR | - |
| LNG IUS | EXPERIMENTAL | Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase. |
| Name | Type | Description |
|---|---|---|
| LNG-IUS (BAY 86-5028) | DRUG | LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 12 months with an follow-up extension for up to 3 years |
| 68 mg etonorgestrel implant for subdermal use (Nexplanon) | DRUG | Implant insertion will occur at randomization visit (Visit 2). Duration of study treatment is 12 months, may be continued up to 3 years under standard care. |
| LNG IUS | DRUG | LNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by WHO guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase. |
Inclusion Criteria: * Signed and dated the informed consent * Healthy female subjects in need of contraception * Age: between 18 and 35 years (inclusive) at Screening visit * Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at scree...
LNG-IUS is a levonorgestrel-releasing intrauterine system developed by Bayer AG. It is an investigational small molecule in Phase 3 clinical development for two indications: contraception and menopause. LNG-IUS is also known as BAY 86-5028.
LNG-IUS is being studied for contraception and for menopause, specifically as part of hormone replacement therapy. One Phase 3 trial evaluated its use as a contraceptive, and another assessed the transfer from contraceptive use to use as part of hormone replacement therapy.
LNG-IUS is developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor of the clinical development program for this levonorgestrel-releasing intrauterine system.
LNG-IUS is in Phase 3 clinical development. It is investigational and has not been approved. The program includes completed Phase 3 trials in contraception and menopause, with a combined enrollment of more than 1,100 participants across the two studies.
LNG-IUS has been studied in two completed Phase 3 trials. NCT01397097 compared LNG-IUS with the etonogestrel subdermal implant Nexplanon in 766 participants for contraception. NCT00185458 assessed transfer from contraceptive use to hormone replacement therapy use in 394 menopausal participants.
Yes. LNG-IUS is also known as BAY 86-5028 and LNG IUS. These names refer to the same levonorgestrel-releasing intrauterine system developed by Bayer AG for contraception and menopause.