| Primary | Number of Bleeding Days | Measured by using Subject Diaries (Subject Reported Data) | Intention to treat population (ITT); all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Median | Inter-Quartile Range | Bleeding days | | Last 90 days in Contraception Phase and first 360 days in Hormone-Replacement Therapy (HRT) Phase | | | | ID | Title | Description |
|---|
| OG000 | Reference Period -1 (Contraception Phase) | Patient assessment within the last 90-days before starting the HRT | | OG001 | Reference Period 1 (HRT Phase) | Patient assessment within the first 90-days of the HRT phase | | OG002 | Reference Period 2 (HRT Phase) | Patient assessment within day 91 to 180 of the HRT phase | | OG003 | Reference Period 3 (HRT Phase) | Patient assessment within day 181 to 270 of the HRT phase | | OG004 | Reference Period 4 (HRT Phase) | Patient assessment within day 271 to 360 of the HRT phase |
| | Units | Counts |
|---|
| Participants | - OG000165
- OG001154
- OG002151
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000(0 to 2)
- OG0010(0 to 1)
- OG0020(0 to 2)
- OG003
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Time effect tested with Friedman's two-way analysis of variance (ANOVA). The null-hypothesis is that the means are equal at the reference period tested. | Friedman's two-way ANOVA | | 0.128 | | | | | | | 95 | | | | | | No | Superiority or Other | | |
|
| Primary | Number of Spotting Days | Measured by using Subject Diaries (Subject Reported Data) | ITT; all subjects with adequate bleeding diary data. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Median | Inter-Quartile Range | Spotting days | | Last 90 days in Contraception Phase and first 360 days in HRT Phase | | | | ID | Title | Description |
|---|
| OG000 | Reference Period -1 (Contraception Phase) | Patient assessment within the last 90-days before starting the HRT | | OG001 | Reference Period 1 (HRT Phase) | Patient assessment within the first 90-days of the HRT phase | | OG002 | Reference Period 2 (HRT Phase) | Patient assessment within day 91 to 180 of the HRT phase | | OG003 | Reference Period 3 (HRT Phase) | Patient assessment within day 181 to 270 of the HRT phase | |
|
| Primary | Percentage of Participants With Successful Treatment | 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
| ITT; all subjects eligible for the HRT | Posted | | Number | | Percentage of participants with success | | Last 90 days in Contraception Phase and first 360 days in HRT Phase | | | | ID | Title | Description |
|---|
| OG000 | LNG IUS | 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. |
| |
| Secondary | Assessment of QOL as Measured by Women's Health Questionnaire | Women's Health Questionnaire (Total Score). For the Total score, the minimum is 36 and maximum is 144. A higher score means the distress and dysfunction are less pronounced. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
| |
| Secondary | Continuation Rates | Percentage of subjects continuing in the study at the given time points. | ITT. Kaplan-Meier estimator given. | Posted | | Number | | Percentage of participants continuing | | At entry, at 2 years, at 4 years | | | | ID | Title | Description |
|---|
| OG000 | LNG IUS | 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. |
| |
| Secondary | Progestogenic Symptom 1: Headache (as Measured by a Visual Analogue Scale (VAS)) | Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
| |
| Secondary | Progestogenic Symptom 2: Depressive Mood (as Measured by a VAS) | Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
| |
| Secondary | Progestogenic Symptom 3: Acne or Greasy Skin (as Measured by a VAS) | Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
| |
| Secondary | Progestogenic Symptom 4: Nausea (as Measured by a VAS) | Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
| |
| Secondary | Progestogenic Symptom 5: Edema (as Measured by a VAS) | Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
| |
| Secondary | Progestogenic Symptom 6: Decreased Libido (as Measured by a VAS) | Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
| |
| Secondary | Climacteric Symptom 1: Hot Flushes (as Measured by a VAS) | Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
| |
| Secondary | Climacteric Symptom 2: Sweating Episodes (as Measured by a VAS) | Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
| |
| Secondary | Climacteric Symptom 3: Vaginal Dryness (as Measured by a VAS) | Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
| |
| Secondary | Climacteric Symptom 4: Sleep Problems (as Measured by a VAS) | Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
| |
| Secondary | Climacteric Symptom 5: Irritability (as Measured by a VAS) | Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
| |
| Secondary | Climacteric Symptom 6: Breast Tension (as Measured by a VAS) | Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
| |
| Secondary | Progestogenic Symptom 7: Hair Loss (as Measured by a VAS) | Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
| |
| Secondary | Progestogenic Symptom 8: Greasy Hair (as Measured by a VAS) | Higher value means the symptom is more pronounced. Minimum is 0, maximum is 100. | ITT. Only the subjects that were eligible for the HRT are included. Due to dropouts and missing data the number of subjects do not necessarily sum up to 168, the number of subjects of the ITT, who qualified for the HRT phase. | Posted | | Mean | Standard Deviation | score on a scale | | Last measurement before start of HRT phase, 6 months after start of HRT phase, 12 month after start of HRT phase | | | | ID | Title | Description |
|---|
| OG000 | Last Measurement Before Start of HRT Phase | Patient assessment at the end of contraception phase | | OG001 | 6 Months After Start of HRT Phase | Patient assessment about day 180 of the HRT phase | | OG002 | 12 Months After Start of HRT Phase | Patient assessment about day 360 of the HRT phase |
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