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.
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.
Study Type
OBSERVATIONAL
Enrollment
999
Site reference ID/Investiagor# 82286
Aktobe, Kazakhstan
Site reference ID/Investiagor# 82287
Aktobe, Kazakhstan
Site reference ID/Investigator# 101795
Aktobe, Kazakhstan
Site reference ID/Investigator# 101799
Aktobe, Kazakhstan
Site reference ID/Investigator# 82279
Aktobe, Kazakhstan
Site reference ID/Investigator# 101798
Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)
Time frame: up to 6 months
Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)
Time frame: up to 6 months
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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Aktobe, Kazakhstan
Site reference ID/Investiagor# 82281
Almaty, Kazakhstan
Site reference ID/Investigator# 82293
Almaty, Kazakhstan
Site reference ID/Investigator# 101796
Astana, Kazakhstan
Site reference ID/Investigator# 101797
Astana, Kazakhstan
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