BE-80-2300342

Study to treat sleep disorders related to menopause

40-65 years
  • Female
< 7 days
2
1206

Are you

  • a woman
  • between the ages of 40 and 65 (inclusive)
  • with a BMI between 18 and 38 kg/m² (inclusive)
  • (post)menopausal and your uterus was removed >6 weeks before screening visit 1
  • who suffers from hot flashes related to menopause
  • who suffers from sleep disorders related to menopause (frequent waking and/or poor sleep quality), with repercussions on daily life
  • not taking or willing to stop daily medication (including hormonal therapy)

What does the study involve?

In study BE-80-2300342, SGS CPU is investigating the treatment of sleep disorders associated with menopause. 
The study lasts +/- 23 weeks with following contact moments:

  • A screening visit 1
  • A screening visit 2 consisting of a stay of 2 days and 2 nights in the sleep clinic of the UZA
  • 2 periods consisting of a stay of 2 days and 2 nights in the UZA sleep clinic
  • 1 outpatient visit between period 1 and period 2
  • 1 telephone follow-up visit after period 2
  • Daily intake of test medication for 12 weeks, both at home and during stays at the UZA sleep clinic

Participate in this study and

  • contribute to the medicine of tomorrow
  • A tax-free reimbursement is provided (in Belgium)

This study was approved by the authorities and an independent ethical committee.

View the information leaflet

BE-80-2300342

Registration form

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