Irregular Menstrual Cycle
Conditions
Keywords
Dydrogesterone, Irregular Menstrual Cycle, Progestins
Brief summary
Dydrogesterone is approved in more than 100 countries including Russia, Ukraine, Kazakhstan and Uzbekistan and widely used for the treatment of progesterone deficiencies such as for management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles, dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual miscarriage, infertility due to luteal insufficiency, as well as part of hormone replacement therapy. There are limited data regarding dydrogesterone's role in achieving cycle regularization from post-marketing settings. There is need to assess the persistence of dydrogesterone therapy in a post-marketing setting after cessation of treatment and whether the persistence, if any, is related to the duration of dydrogesterone therapy. Hence, in this observational program, the goal is to observe the possible implications of such treatment in terms of treatment length and response pattern.
Detailed description
The program is designed as a prospective, multicentre, observational, non-interventional, non-randomized, non-controlled, single arm, post-marketing program. Being an observational program, the assignment of patients to dydrogesterone therapy will not be decided with an intention to include patients in the program, but will be guided as per standard clinical practice of the treating physician. Hence the prescribing of dydrogesterone will be clearly separate from the decision to include patients in this program. All dydrogesterone prescriptions will be made in accordance with locally approved package insert for dydrogesterone.
Interventions
None listed
Sponsors
Abbott
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18-40 years * Irregular menstrual cycle due to progesterone deficiency for at least 3 months * Dydrogesterone prescribed in accordance with locally approved package insert * Signed written authorization to provide data for the program
Exclusion criteria
* Known hypersensitivity to the active ingredient or excipients * Known or suspected progesterone-dependent neoplasms * Vaginal bleeding of unknown etiology * Administration of oral contraceptives * Any other condition that precludes use of dydrogesterone in a particular patient, in accordance with the contraindication, precautions and special warnings listed in the locally approve package insert (for example, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) | up to 6 months |
| Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) | up to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period | Up to 6 months | 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 |
| Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea | From 1 month to 6 months | Polymenorrhea was defined as cycle duration \< 21 days and the change in duration of the menstrual cycle during treatment was evaluated |
| Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea | From 1 month to 6 months | Oligomenorrhea is defined as cycle duration \> 35 days and the change in duration of the menstrual cycle during treatment was evaluated |
| Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea | From 1 month to 6 months | Polymenorrhea is defined as cycle duration \< 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days |
| Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea | From 1 month to 6 months | Oligomenorrhea is defined as cycle duration \> 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days |
| Change of Pain Intensity During Menstruation From Baseline to End of Treatment | From 1 month to 6 months | Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain |
| Change of Intensity of Anxiety From Baseline to the End of Treatment | From 1 month to 6 months | Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety |
| Patient Satisfaction With the Treatment | Up to 6 months | 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. |
| Overall Clinical Response on Treatment Assessed by Physician | Up to 6 months | 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. |
| 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 | Up to 9 months | 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 |
| 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 | Up to 12 months | 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 |
| Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea | From 1 month to 12 months | Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration \< 21 days |
| Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea | From 1 month to 12 months | Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration \> 35 days |
| Change of Pain Intensity During Menstruation | From 1 month to 12 months | 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 |
| Change of Intensity of Anxiety | From 1 month to 12 months | 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 |
| Time to Relapse | Up to 6 months or longer after ended treatment | 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. |
Countries
Kazakhstan, Russia, Ukraine, Uzbekistan
Participant flow
Pre-assignment details
A total of 1000 patients were screened. 1 Patient failed screening and 999 were enrolled into the program.
Participants by arm
| Arm | Count |
|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician | 955 |
| Total | 955 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lost to Follow-up | 46 |
| Overall Study | no reason specified | 22 |
| Overall Study | Pregnancy | 56 |
| Overall Study | variety of other minor reasons | 83 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Women Received Dydrogesterone for Irregular Menstrual Cycle |
|---|---|
| Age, Continuous | 28.3 years STANDARD_DEVIATION 5.8 |
| Region of Enrollment Kazakhstan | 129 participants |
| Region of Enrollment Russian Federation | 382 participants |
| Region of Enrollment Ukraine | 284 participants |
| Region of Enrollment Uzbekistan | 160 participants |
| Sex: Female, Male Female | 955 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 986 |
| serious Total, serious adverse events | 2 / 986 |
Outcome results
Primary
Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)
Time frame: up to 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) | 1 therapy cycle | 1 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) | 2 therapy cycles | 4 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) | 3 therapy cycles | 269 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) | 4 therapy cycles | 66 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) | 5 therapy cycles | 53 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number) | 6 therapy cycles | 467 participants |
Primary
Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)
Time frame: up to 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) | 0 regular cycles | 6 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) | 1 regular cycle | 32 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) | 2 regular cycles | 31 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) | 3 regular cycles | 29 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) | 4 regular cycles | 26 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) | 5 regular cycles | 56 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) | 6 regular cycles | 545 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) | 7 regular cycles | 84 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) | 8 regular cycles | 40 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles) | 9 regular cycles | 11 participants |
Comparison: Test of association between the number of regular menstrual cycles during the follow-up period and the number of dydrogesterone therapy cycles received during the treatment period (Follow-up Analysis Set) Follow-up Analysis Set (N=915)p-value: 0.3181Mantel Haenszel
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
Time frame: From 1 month to 6 months
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea | -15.7 days | Standard Deviation 19.8 |
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
Time frame: From 1 month to 6 months
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea | 4.9 days | Standard Deviation 5.9 |
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
Time frame: From 1 month to 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea | 0.1 days | Standard Deviation 1.1 |
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
Time frame: From 1 month to 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea | -0.0 days | Standard Deviation 1.2 |
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
Time frame: From 1 month to 6 months
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea | -1.4 days | Standard Deviation 2 |
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
Time frame: From 1 month to 6 months
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea | -1.7 days | Standard Deviation 2.5 |
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
Time frame: From 1 month to 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Change of Intensity of Anxiety | -0.1 units on a scale | Standard Deviation 1.7 |
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
Time frame: From 1 month to 6 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Change of Intensity of Anxiety From Baseline to the End of Treatment | -2.7 units on a scale | Standard Deviation 2.8 |
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
Time frame: From 1 month to 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Change of Pain Intensity During Menstruation | -0.3 units on a scale | Standard Deviation 1.8 |
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
Time frame: From 1 month to 6 months
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Change of Pain Intensity During Menstruation From Baseline to End of Treatment | -2.8 units on a scale | Standard Deviation 2.8 |
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.
Time frame: Up to 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Overall Clinical Response on Treatment Assessed by Physician | excellent | 320 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Overall Clinical Response on Treatment Assessed by Physician | good | 499 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Overall Clinical Response on Treatment Assessed by Physician | fair | 90 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Overall Clinical Response on Treatment Assessed by Physician | poor | 10 participants |
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.
Time frame: Up to 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Patient Satisfaction With the Treatment | Very satisfied | 288 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Patient Satisfaction With the Treatment | satisfied | 568 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Patient Satisfaction With the Treatment | somewhat satisfied | 55 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Patient Satisfaction With the Treatment | dissatisfied | 7 participants |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Patient Satisfaction With the Treatment | very dissatisfied | 1 participants |
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
Time frame: Up to 6 months
Population: Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period | 99.1 percentage of subjects |
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
Time frame: Up to 9 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | 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 | yes | 91.7 percentage of subjects |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | 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 | no | 8.3 percentage of subjects |
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
Time frame: Up to 12 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | 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 | yes | 78.5 percentage of subjects |
| Women Received Dydrogesterone for Irregular Menstrual Cycle | 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 | no | 21.5 percentage of subjects |
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.
Time frame: Up to 6 months or longer after ended treatment
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Women Received Dydrogesterone for Irregular Menstrual Cycle | Time to Relapse | 85 percentage of subjects |