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

Completed

Conditions: Irregular Menstrual Cycle

Registration Number: NCT01711216

Lead Sponsor: Abbott

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 999

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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 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
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
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
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 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.
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
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.
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
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.

Trial Locations

Locations (66): Site reference ID/Investigaotr# 76705
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Tomsk, Russian Federation
Site reference ID/Investigaot# 88513
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Voronezh, Russian Federation
Site reference ID/Investigaot# 88056
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Lviv, Ukraine
Site reference ID/Investigaot# 91973
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Andijan, Uzbekistan
Site reference ID/Investigaot# 91975
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Fergana, Uzbekistan
Site reference ID/Investigaot# 91980
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Urgench, Uzbekistan
Site reference ID/Investigaot# 91986
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Samarkand, Uzbekistan
Site reference ID/Investigaot# 91982
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Tashkent, Uzbekistan
Site reference ID/Investigaot# 91984
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Tashkent, Uzbekistan
Site reference ID/Investigator# 82279
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Aktobe, Kazakhstan
Site reference ID/Investigator# 101798
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Aktobe, Kazakhstan
Site reference ID/Investiagor# 82281
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Almaty, Kazakhstan
Site reference ID/Investigator# 82277
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Astana, Kazakhstan
Site reference ID/Investigator# 101797
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Astana, Kazakhstan
Site reference ID/Investigator# 82300
🇰🇿
Astana, Kazakhstan
Site reference ID/Investigator# 82301
🇰🇿
Astana, Kazakhstan
Site reference ID/Investigaotr# 76702
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Irkutsk, Russian Federation
Site reference ID/Investigator# 82293
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Almaty, Kazakhstan
Site reference ID/Investigator# 77753
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Kazan, Russian Federation
Site reference ID/Investigaotr# 76704
🇷🇺
Kemerovo, Russian Federation
Site reference ID/Investigator# 83633
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Novosibirsk, Russian Federation
Site reference ID/Investigator# 101796
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Astana, Kazakhstan
Site reference ID/Investigator# 76701
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Krasnodar, Russian Federation
Site reference ID/Investigaotr# 76708
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Moscow, Russian Federation
Site reference #/Investigator ID 77816
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Kharkiv, Ukraine
Site reference ID/Investigaot# 75817
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Kharkiv, Ukraine
Site Reference ID/Investigator# 75814
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Kiev, Ukraine
Site reference ID/Investigaot# 80193
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Odesa, Ukraine
Site reference ID/Investigator# 82288
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Shymkent, Kazakhstan
Site reference ID/Investigator# 82035
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Ekaterinburg, Russian Federation
Site reference ID/Investigaotr# 76709
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St. Petersburg, Russian Federation
Site Reference ID/Investigator# 75816
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Ivano-Frankivsk, Ukraine
Site reference ID/Investigaot# 88537
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Moscow, Russian Federation
Site reference ID/Investigaot# 91981
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Tashkent, Uzbekistan
Site reference ID/Investigaot# 91988
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Tashkent, Uzbekistan
Site reference ID/Investigator# 82299
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Astana, Kazakhstan
Site reference ID/Investiagor# 82282
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Shymkent, Kazakhstan
Site reference ID/Investigator# 82275
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Shymkent, Kazakhstan
Site reference ID/Investigaot# 88535
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Moscow, Russian Federation
Site reference ID/Investigaot# 88536
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St. Petersburg, Russian Federation
Site reference ID/Investigator# 82036
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Volgograd, Russian Federation
Site reference ID/Investigaot# 75813
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Kiev, Ukraine
Site reference ID/Investigator# 77754
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St. Petersburg, Russian Federation
Site reference ID/Investigator# 77755
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Tumen, Russian Federation
Site reference ID/Investigaot# 75819
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Mykolaiv, Ukraine
Site reference ID/Investigaot# 77817
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Odesa, Ukraine
Site reference ID/Investigaot# 91974
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Andijan, Uzbekistan
Site reference ID/Investigaot# 100616
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Tashkent, Uzbekistan
Site reference ID/Investigaot# 91977
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Tashkent, Uzbekistan
Site reference ID/Investigaot# 75815
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Dnipropetrovsk, Ukraine
Site reference ID/Investigator # 77813
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Ternopil, Ukraine
Site reference ID/Investigaot# 75818
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Vinnytsia, Ukraine
Site reference ID/Investigaot# 91985
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Urgench, Uzbekistan
Site Reference ID/Investigator# 75822
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Zaporizhzhia, Ukraine
Site reference ID/Investigaot# 91987
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Bukhara, Uzbekistan
Site reference ID/Investigaot# 92473
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Tashkent, Uzbekistan
Site reference ID/Investigaot# 92474
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Tashkent, Uzbekistan
Site reference ID/Investiagor# 82286
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Aktobe, Kazakhstan
Site reference ID/Investiagor# 82287
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Aktobe, Kazakhstan
Site reference ID/Investigator# 101795
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Aktobe, Kazakhstan
Site reference ID/Investigator# 101799
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Aktobe, Kazakhstan
Site reference ID/Investigaot# 88514
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Nizhniy Novgorod, Russian Federation
Site reference ID/Investigaot# 91976
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Tashkent, Uzbekistan
Site reference ID/Investigaot# 91983
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Tashkent, Uzbekistan
Site reference ID/Investigator# 76700
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Moscow, Russian Federation
Site reference ID/Investigator# 87013
🇷🇺
Moscow, Russian Federation