Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LNG IUS · 1 trial · 1 indication
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 |
|---|---|---|
| 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 | 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: * Women with intact uterus, regular menstrual cycles and no previous or current climacteric symptoms. Exclusion Criteria: * Pregnancy or lactation. * Previous pelvic infections. * Abnormal bleeding. * Abnormal uterine cavity. * Uterine polyps. * Genital cancer. * Liver disease...
LNG IUS, also known as the levonorgestrel intrauterine system, is used for contraception and as part of hormone replacement therapy (HRT) in menopause. It is being developed by Bayer AG for these indications and is currently in Phase 3 clinical development.
LNG IUS is a small molecule that delivers the hormone levonorgestrel locally in the uterus. It is used for contraception and as part of hormone replacement therapy in menopause, though its specific molecular target is not detailed.
LNG IUS is developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is currently in Phase 3 clinical development for use in contraception and as part of hormone replacement therapy for menopause.
LNG IUS is in Phase 3 clinical development. It is an investigational drug and is not yet approved for use. Clinical trials have been completed to assess its use in contraception and as part of hormone replacement therapy in menopause.
LNG IUS has been studied in two completed Phase 3 clinical trials. One trial, NCT00185458, assessed the transfer from using LNG IUS as a contraceptive to using it as part of hormone replacement therapy in menopause, enrolling 394 women. Another trial, NCT01397097, compared discontinuation rates of LNG IUS versus the ENG subdermal implant, enrolling 766 women.
Yes, LNG IUS is the same as the levonorgestrel intrauterine system. It is a small molecule drug developed by Bayer AG for contraception and as part of hormone replacement therapy in menopause, and it is currently in Phase 3 clinical development.