Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Post-Marketing, Prospective, Multicenter, Observational Program: Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan

Conditions
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Irregular Menstrual Cycle

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women received dydrogesterone for irregular menstrual cycle<br>Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Up to 6 months | 
| 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 | From 1 month to 6 months | 
| 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 | From 1 month to 6 months | 
| 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 | From 1 month to 6 months | 
| 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 | From 1 month to 6 months | 
| 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 | From 1 month to 6 months | 
| 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 | From 1 month to 6 months | 
| 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. | Up to 6 months | 
| 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. | Up to 6 months | 
| 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 | Up to 9 months | 
| 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 | Up to 12 months | 
| 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 | From 1 month to 12 months | 
| 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 | From 1 month to 12 months | 
| 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 | From 1 month to 12 months | 
| 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 | From 1 month to 12 months | 
| 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. | Up to 6 months or longer after ended treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dydrogesterone, Irregular Menstrual Cycle, Progestins