Duphaston in Cycle Regularization: A Post-marketing, Prospective, Multicenter, Observational Study

• Percentage of patients reporting a regular cycle [ Time Frame: 1-8 months ] [ Designated as safety issue: No ]
  Regular cycle is defined as cycle duration between 21 to 35 days, inclusive at the end of treatment period.
  
  

• Mean cycle duration (in days) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  
• Amount of menstrual bleeding [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  Assessment of average number of pads changed per day at baseline and at the end of treatment.
  
  
• Pain during menstruation [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  Pain during menstruation (on four point severity scale: nil, mild, moderate, severe) from cessation of treatment to end follow up, by assessing percentage of patients in each category at end of treatment and at the end of follow up.
  
  
• Overall patient satisfaction [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  Overall patient satisfaction will be assessed (on four point scale: excellent, good, fair and poor) at the end of treatment.
  
  

    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 < 21 days) and oligomenorrhea (i.e., cycle duration > 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 < 21 days or > 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.