Clinical trial NCT01711216: Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irregular Menstrual Cycle
Keywords: Dydrogesterone
Irregular Menstrual Cycle
Progestins
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2012-10-22
Enrollment: 999
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with irregular menstrual cycle due to progesterone deficiency

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)
timeFrame: up to 6 months
measure: Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)
timeFrame: up to 6 months
Secondary outcomes:
measure: Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period
timeFrame: Up to 6 months
measure: Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea
timeFrame: From 1 month to 6 months
measure: Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea
timeFrame: From 1 month to 6 months
measure: Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea
timeFrame: From 1 month to 6 months
measure: Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea
timeFrame: From 1 month to 6 months
measure: Change of Pain Intensity During Menstruation From Baseline to End of Treatment
timeFrame: From 1 month to 6 months
measure: Change of Intensity of Anxiety From Baseline to the End of Treatment
timeFrame: From 1 month to 6 months
measure: Patient Satisfaction With the Treatment
timeFrame: Up to 6 months
measure: Overall Clinical Response on Treatment Assessed by Physician
timeFrame: Up to 6 months
measure: 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
timeFrame: Up to 9 months
measure: 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
timeFrame: Up to 12 months
measure: Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea
timeFrame: From 1 month to 12 months
measure: Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea
timeFrame: From 1 month to 12 months
measure: Change of Pain Intensity During Menstruation
timeFrame: From 1 month to 12 months
measure: Change of Intensity of Anxiety
timeFrame: From 1 month to 12 months
measure: Time to Relapse
timeFrame: Up to 6 months or longer after ended treatment
Other outcomes:
Locations:
city: Aktobe
country: Kazakhstan
facility: Site reference ID/Investiagor# 82286
city: Aktobe
country: Kazakhstan
facility: Site reference ID/Investiagor# 82287
city: Aktobe
country: Kazakhstan
facility: Site reference ID/Investigator# 101795
city: Aktobe
country: Kazakhstan
facility: Site reference ID/Investigator# 101799
city: Aktobe
country: Kazakhstan
facility: Site reference ID/Investigator# 82279
city: Aktobe
country: Kazakhstan
facility: Site reference ID/Investigator# 101798
city: Almaty
country: Kazakhstan
facility: Site reference ID/Investiagor# 82281
city: Almaty
country: Kazakhstan
facility: Site reference ID/Investigator# 82293
city: Astana
country: Kazakhstan
facility: Site reference ID/Investigator# 101796
city: Astana
country: Kazakhstan
facility: Site reference ID/Investigator# 101797
city: Astana
country: Kazakhstan
facility: Site reference ID/Investigator# 82277
city: Astana
country: Kazakhstan
facility: Site reference ID/Investigator# 82299
city: Astana
country: Kazakhstan
facility: Site reference ID/Investigator# 82300
city: Astana
country: Kazakhstan
facility: Site reference ID/Investigator# 82301
city: Shymkent
country: Kazakhstan
facility: Site reference ID/Investiagor# 82282
city: Shymkent
country: Kazakhstan
facility: Site reference ID/Investigator# 82275
city: Shymkent
country: Kazakhstan
facility: Site reference ID/Investigator# 82288
city: Ekaterinburg
country: Russian Federation
facility: Site reference ID/Investigator# 82035
city: Irkutsk
country: Russian Federation
facility: Site reference ID/Investigaotr# 76702
city: Kazan
country: Russian Federation
facility: Site reference ID/Investigator# 77753
city: Kemerovo
country: Russian Federation
facility: Site reference ID/Investigaotr# 76704
city: Krasnodar
country: Russian Federation
facility: Site reference ID/Investigator# 76701
city: Moscow
country: Russian Federation
facility: Site reference ID/Investigaot# 88537
city: Moscow
country: Russian Federation
facility: Site reference ID/Investigaotr# 76708
city: Moscow
country: Russian Federation
facility: Site reference ID/Investigator# 76700
city: Moscow
country: Russian Federation
facility: Site reference ID/Investigator# 87013
city: Moscow
country: Russian Federation
facility: Site reference ID/Investigaot# 88535
city: Nizhniy Novgorod
country: Russian Federation
facility: Site reference ID/Investigaot# 88514
city: Novosibirsk
country: Russian Federation
facility: Site reference ID/Investigator# 83633
city: St. Petersburg
country: Russian Federation
facility: Site reference ID/Investigaot# 88536
city: St. Petersburg
country: Russian Federation
facility: Site reference ID/Investigaotr# 76709
city: St. Petersburg
country: Russian Federation
facility: Site reference ID/Investigator# 77754
city: Tomsk
country: Russian Federation
facility: Site reference ID/Investigaotr# 76705
city: Tumen
country: Russian Federation
facility: Site reference ID/Investigator# 77755
city: Volgograd
country: Russian Federation
facility: Site reference ID/Investigator# 82036
city: Voronezh
country: Russian Federation
facility: Site reference ID/Investigaot# 88513
city: Dnipropetrovsk
country: Ukraine
facility: Site reference ID/Investigaot# 75815
city: Ivano-Frankivsk
country: Ukraine
facility: Site Reference ID/Investigator# 75816
city: Kharkiv
country: Ukraine
facility: Site reference #/Investigator ID 77816
city: Kharkiv
country: Ukraine
facility: Site reference ID/Investigaot# 75817
city: Kiev
country: Ukraine
facility: Site reference ID/Investigaot# 75813
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 75814
city: Lviv
country: Ukraine
facility: Site reference ID/Investigaot# 88056
city: Mykolaiv
country: Ukraine
facility: Site reference ID/Investigaot# 75819
city: Odesa
country: Ukraine
facility: Site reference ID/Investigaot# 77817
city: Odesa
country: Ukraine
facility: Site reference ID/Investigaot# 80193
city: Ternopil
country: Ukraine
facility: Site reference ID/Investigator # 77813
city: Vinnytsia
country: Ukraine
facility: Site reference ID/Investigaot# 75818
city: Zaporizhzhia
country: Ukraine
facility: Site Reference ID/Investigator# 75822
city: Andijan
country: Uzbekistan
facility: Site reference ID/Investigaot# 91973
city: Andijan
country: Uzbekistan
facility: Site reference ID/Investigaot# 91974
city: Bukhara
country: Uzbekistan
facility: Site reference ID/Investigaot# 91987
city: Fergana
country: Uzbekistan
facility: Site reference ID/Investigaot# 91975
city: Samarkand
country: Uzbekistan
facility: Site reference ID/Investigaot# 91986
city: Tashkent
country: Uzbekistan
facility: Site reference ID/Investigaot# 100616
city: Tashkent
country: Uzbekistan
facility: Site reference ID/Investigaot# 91984
city: Tashkent
country: Uzbekistan
facility: Site reference ID/Investigaot# 91977
city: Tashkent
country: Uzbekistan
facility: Site reference ID/Investigaot# 91981
city: Tashkent
country: Uzbekistan
facility: Site reference ID/Investigaot# 91982
city: Tashkent
country: Uzbekistan
facility: Site reference ID/Investigaot# 92473
city: Tashkent
country: Uzbekistan
facility: Site reference ID/Investigaot# 91988
city: Tashkent
country: Uzbekistan
facility: Site reference ID/Investigaot# 92474
city: Tashkent
country: Uzbekistan
facility: Site reference ID/Investigaot# 91976
city: Tashkent
country: Uzbekistan
facility: Site reference ID/Investigaot# 91983
city: Urgench
country: Uzbekistan
facility: Site reference ID/Investigaot# 91980
city: Urgench
country: Uzbekistan
facility: Site reference ID/Investigaot# 91985
Study officials:
affiliation: Abbott
name: Claire Pexman-Fieth, MD
role: STUDY_DIRECTOR
References: