Screening phase | Treatment phase Triptorelin SR 11.25 mg injected 3-monthly starting at baseline. Tibolone 2.5 mg tablet taken daily from baseline. | Follow-up phase | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Visit 1 Screen | Visit 22 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 | Visit 8 | Visit 9 | Visit 10 | Visit 11 | |
Written informed consent | X | ||||||||||
Medical history | X | ||||||||||
History of CCPP | X | ||||||||||
Physical examination | X | X | X | ||||||||
Vital signs 5 | X | X | X | X | X | ||||||
Urine pregnancy test | X | ||||||||||
Review of Inclusion / Exclusion Criteria | X | X | |||||||||
Enrolment in the study | X | ||||||||||
Bone density (DEXA) | X | X | X | X | |||||||
CPG questionnaire | X | X | X | X | X | X | |||||
EHP-30 questionnaire | X | X | X | X | X | X | |||||
Blood samples for haematology and biochemistry | X | X | X | X | |||||||
Triptorelin injection | X | X | X | X | X | X | X | X | |||
Dispense Tibolone | X | X | X | X | X | X | X | X | |||
Tibolone compliance checked | X | X | X | X | X | X | X | X | |||
Dispense patient diary | X | X | X | X | X | X | X | X | X | X | |
Collect patient diary | X | X | X | X | X | X | X | X | X | X | |
Prior and concomitant medications | X | X | X | X | X | X | X | X | X | X | X |
Adverse events | X | X | X | X | X | X | X | X | X | X | |
End of study details | X |