Duphaston in Cycle Regularization: A Post-marketing, Prospective, Multicenter, Observational Study
Condition: Irregular Menstrual Cycle
Study type: Observational

Summary: 
      In India Duphaston is approved 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
      abortion, infertility due to luteal insufficiency, as well as part of hormone replacement
      therapy. One Indian study reported normalization of the cycle in 91.6% of women with
      menstrual problems after three cycles of therapy with dydrogesterone 10 mg given from 11th to
      the 25th day of the menstrual cycle. The mean cycle duration during dydrogesterone therapy in
      this study was noted to be 28.8 days, in contrast to 17.9 days (in the polymenorrhea group)
      and 50.6 days (in the oligomenorrhea group) before therapy. Furthermore, dydrogesterone also
      decreased the amount and duration of menstrual bleeding in this study.

      However, there are limited data regarding Duphaston's role in achieving cycle regularization
      from post-marketing settings. Moreover, it is not well-known if the effect of Duphaston
      therapy persists after cessation of treatment and whether the persistent effect, if any, is
      related to the duration of Duphaston therapy.

      Hence, in this observational study, given that (based on previous clinical studies as
      mentioned above) Duphaston plays a role in menstrual irregularities treatment, the goal is to
      tease out the possible implications of such treatment in terms of treatment length and
      response pattern.
    

Detailed description: 
      Primary objective:

      • To determine percentage of patients reporting a regular cycle (defined as cycle duration
      between 21 to 35 days, inclusive) at the end of treatment period.

      Secondary objectives:

      A. For all patients:

        -  To describe evolution of cycle duration from baseline to end of treatment by assessing
           mean cycle duration (in days) at baseline, separately in polymenorrhea, (i.e., cycle
           duration &lt; 21 days) and oligomenorrhea (i.e., cycle duration &gt; 35 days) groups,
           and at the end of treatment.

        -  To describe evolution of duration of menstrual bleeding from baseline to end of
           treatment by assessing mean duration of menstrual bleeding (in days) at baseline and at
           the end of treatment.

        -  To describe evolution of amount of menstrual bleeding from baseline to end of treatment,
           by assessing average number of pads changed per day at baseline and at the end of
           treatment.

        -  To describe evolution of pain during menstruation (on a 11 point Likert Scale where 0
           means no pain and 10 means worst pain) ) from baseline to end of treatment, by assessing
           mean and standard deviation of pain scores at baseline and at the end of treatment.

        -  To describe overall patient satisfaction (on a 5 point Clinical Global Impression of
           Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4
           = satisfied, 5 = very satisfied) at the end of treatment, by assessing percentages of
           patients in each category at the end of treatment.

        -  To describe overall clinical response (on a 7 point Clinical Global Impression of
           Severity scale, where 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 =
           Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Most extremely
           ill) ) at the end of treatment by assessing percentages of patients in each category at
           the end of treatment.

      B. For patients who had achieved regular cycle at the end of treatment:

        -  To determine the percentage of patients still experiencing regular cycle (i.e., duration
           21-35 days, inclusive) at the end of follow up period, out of total number of patients
           who had achieved cycle regularization at the end of treatment period.

        -  To determine median time to relapse (defined as cycle duration &lt; 21 days or &gt; 35
           days) during the follow up period, for patients who had achieved regular cycle at the
           end of treatment, using Kaplan Meier's method to graphically plot time after cessation
           of treatment versus percentage of patients still having regular cycles.

        -  To determine any correlation between treatment duration (number of cycles of Duphaston
           treatment received) and persistence of effect (number of months until when regular
           cycles are maintained after cessation of Duphaston therapy), using linear regression
           analysis model.

        -  To describe evolution of duration of menstrual bleeding from cessation of treatment to
           end follow up, by assessing mean duration of menstrual bleeding (in days) at end of
           treatment and at the end of follow up.

        -  To describe evolution of amount of menstrual bleeding from cessation of treatment to end
           follow up, by assessing average number of pads changed per day at end of treatment and
           at the end of follow up.

        -  To describe evolution of pain during menstruation (on a 11 point Likert Scale where 0
           means no pain and 10 means worst pain) from cessation of treatment to end follow up, by
           assessing mean and standard deviation of pain scores at end of treatment and at the end
           of follow up.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with irregular menstrual cycle
      
Keywords: Duphaston Study