CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 999 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01711216
NCT01711216N/ACompleted

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

Abbott·observational·Posted Oct 22, 2012·Updated Dec 22, 2015

In Brief

An observational study for Irregular Menstrual Cycle. Completed, enrolled 999 participants across 66 sites in 4 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesKazakhstan, Russia, Ukraine, Uzbekistan
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2012
Enrollment StartAug 1, 2012
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 13.7 years ago