| Secondary | Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period | Regular cycle is defined as cycle duration between 21 to 35 days, inclusive. Treatment period in this observational program can be from 1 cycle to 6 consecutive cycles. This program does not include patients who required dydrogesterone therapy, according to physician's decision, more than 6 consecutive cycles | Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles | Posted | | Number | | percentage of subjects | | Up to 6 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea | Polymenorrhea was defined as cycle duration < 21 days and the change in duration of the menstrual cycle during treatment was evaluated | Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS | Posted | | Mean | Standard Deviation | days | | From 1 month to 6 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea | Oligomenorrhea is defined as cycle duration > 35 days and the change in duration of the menstrual cycle during treatment was evaluated | Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS | Posted | | Mean | Standard Deviation | days | | From 1 month to 6 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea | Polymenorrhea is defined as cycle duration < 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days | Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS | Posted | | Mean | Standard Deviation | days | | From 1 month to 6 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea | Oligomenorrhea is defined as cycle duration > 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days | Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS | Posted | | Mean | Standard Deviation | days | | From 1 month to 6 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Change of Pain Intensity During Menstruation From Baseline to End of Treatment | Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain | Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data from 39 patients missing | Posted | | Mean | Standard Deviation | units on a scale | | From 1 month to 6 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Change of Intensity of Anxiety From Baseline to the End of Treatment | Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety | Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 51 patients missing. | Posted | | Mean | Standard Deviation | units on a scale | | From 1 month to 6 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Patient Satisfaction With the Treatment | Patient satisfaction will be determined based on a 5-point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied. | Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed. | Posted | | Number | | participants | | Up to 6 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Overall Clinical Response on Treatment Assessed by Physician | Overall clinical response assessed by physician will be determined based on a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor response. | Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed. | Posted | | Number | | participants | | Up to 6 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Proportion of Patients With 3 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period | Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive | Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. | Posted | | Number | | percentage of subjects | | Up to 9 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Proportion of Patients With 6 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period | Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive | Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. | Posted | | Number | | percentage of subjects | | Up to 12 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea | Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration < 21 days | Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with polymenorrhea in subset of FAS. | Posted | | Mean | Standard Deviation | days | | From 1 month to 12 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea | Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration > 35 days | Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with oligomenorrhea in subset of FAS. | Posted | | Mean | Standard Deviation | days | | From 1 month to 12 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Change of Pain Intensity During Menstruation | Measured only for patients who had achieved cycle regularization at the end of treatment period. Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain | Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. | Posted | | Mean | Standard Deviation | units on a scale | | From 1 month to 12 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Change of Intensity of Anxiety | Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety | Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. | Posted | | Mean | Standard Deviation | units on a scale | | From 1 month to 12 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Primary | Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) | | Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed. | Posted | | Number | | participants | | up to 6 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Primary | Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) | | Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed. | Posted | | Number | | participants | | up to 6 months | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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| Secondary | Time to Relapse | The intention was to measure time to relapse, but since a regular cycle was maintained longer than the period of follow up observation, no resulting variable counted in time was received. Instead, what was measured was the percentage of participants who maintained a regular cycle. Measured only for patients who had achieved cycle regularization at the end of treatment period. | Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Among the patients who achieved cycle regularization (Follow-up Analysis Set), a majority (>85%) maintained regular cycles for the whole follow-up period | Posted | | Number | | percentage of subjects | | Up to 6 months or longer after ended treatment | | | | ID | Title | Description |
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| OG000 | Women Received Dydrogesterone for Irregular Menstrual Cycle | Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician |
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