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

• Number of dydrogesterone therapy cycles received against number of months of maintained regular cycles in follow-up [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  To determine relationship between treatment duration (number of cycles of dydrogesterone treatment received) and persistence (number of months until when regular cycles are maintained after cessation of dydrogesterone therapy)
  
  

• Proportion of patients reporting at least one regular cycle over the treatment period [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  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 [ Time Frame: From 1 month to 6 months ] [ Designated as safety issue: No ]
  Polymenorrhea is defined as cycle duration < 21 days
  
  
• Change of cycle duration from baseline to end of treatment in days in group of patients with oligomenorrhea (i.e., cycle duration > 35 days) [ Time Frame: From 1 month to 6 months ] [ Designated as safety issue: No ]
  Oligomenorrhea is defined as cycle duration > 35 days
  
  
• Change of duration of menstrual bleeding from baseline to end of treatment in days in group of patients with polymenorrhea [ Time Frame: From 1 month to 6 months ] [ Designated as safety issue: No ]
  Polymenorrhea is defined as cycle duration < 21 days
  
  
• Change of duration of menstrual bleeding from baseline to end of treatment in days in group of patients with oligomenorrhea [ Time Frame: From 1 month to 6 months ] [ Designated as safety issue: No ]
  Oligomenorrhea is defined as cycle duration > 35 days
  
  
• Change of pain intensity during menstruation from baseline to end of treatment [ Time Frame: From 1 month to 6 months ] [ Designated as safety issue: No ]
  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 baseline to the end of treatment [ Time Frame: From 1 month to 6 months ] [ Designated as safety issue: No ]
  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 [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  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. Proportion of patients in each category at the end of treatment will be assessed
  
  
• Overall clinical response on treatment assessed by physician [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  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. Proportion of patients in each category at the end of treatment will be assessed
  
  
• 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 [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
  Will be 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
  
  
• 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 [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  Will be 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 duration of menstrual bleeding in days in group of patients with polymenorrhea [ Time Frame: From 1 month to 12 months ] [ Designated as safety issue: No ]
  Will be 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 [ Time Frame: From 1 month to 12 months ] [ Designated as safety issue: No ]
  Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration > 35 days
  
  
• Change of pain intensity during menstruation [ Time Frame: From 1 month to 12 months ] [ Designated as safety issue: No ]
  Will be 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 [ Time Frame: From 1 month to 12 months ] [ Designated as safety issue: No ]
  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
  
  
• Time to relapse [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Time to relapse is defined as cycle duration <21 days or >35 days
  
  

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.