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.
BE-80-2300342