An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults

• Change in mean number of nocturnal voids [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
• Proportion of subjects with > 33% reduction from baseline in mean number of voids [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

• Change in total sleep time [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
• Quality of life [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
• Safety of the "Melt" formulation [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]

• Change in total sleep time [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
• Quality of life [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]
• Treatment safety [ Time Frame: 1-6 months ] [ Designated as safety issue: No ]

The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.

The objective of the present study is to investigate the long-term efficacy and safety of the melt formulation of desmopressin.

• Drug: lyophilisate oral of desmopressin
  10ug placed under the subject's tongue, without water once daily administration one hour before bedtime.
  Other Name: Minirin® Melt
• Drug: lyophilisate oral of desmopressin
  25ug placed under the subject's tongue, without water once daily administration one hour before bedtime.
  Other Name: Minirin® Melt
• Drug: lyophilisate oral of desmopressin
  50ug placed under the subject's tongue, without water once daily administration one hour before bedtime.
  Other Name: Minirin® Melt
• Drug: lyophilisate oral of desmopressin
  100ug placed under the subject's tongue, without water once daily administration one hour before bedtime.
  Other Name: Minirin® Melt

• Active Comparator: Minirin® Melt 10ug
  desmopressin acetate (Minirin® Melt)
  Intervention: Drug: lyophilisate oral of desmopressin
• Active Comparator: Minirin® Melt 25ug
  desmopressin acetate (Minirin® Melt)
  Intervention: Drug: lyophilisate oral of desmopressin
• Active Comparator: Minirin® Melt 50ug
  desmopressin acetate (Minirin® Melt)
  Intervention: Drug: lyophilisate oral of desmopressin
• Active Comparator: Minirin® Melt 100ug
  desmopressin acetate (Minirin® Melt)
  Intervention: Drug: lyophilisate oral of desmopressin

Inclusion Criteria:

• Written informed consent prior to the performance of any study-related activity.
• Currently enrolled in Protocol. FE992026 CS29, entitled "A Randomized, Double Blind,Placebo Controlled, Parallel Group, Multi-Center Study with a Double Blind Extension Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults" and have completed at least Visit 3E in Part 11. Note: All subjects must be randomized into Part I1 of Protocol CS29 and have completed at least Visit 3E (Day 15) prior to rollover into this study. A subject can be enrolled into this study on the same day they complete Visit 3E.

Exclusion Criteria:

(Note: All changes are measured relative to the baseline values established in Protocol CS29)

• Change in mean number of nocturnal voids
• Proportion of subjects with > 33% reduction in the mean number of nocturnal voids
• Change in the duration of the first sleep period
• Change in duration of total sleep time
• Change in nocturia-specific quality of life as assessed by scores on the International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) and the Nocturia Quality of Life Questionnaire (NQoL)
• Change in quality of sleep as assessed by the global score of the Pittsburgh Sleep Quality Index (PSQI)
• Change in overall Quality of Life as assessed by the SF-12
• Treatment safety