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Table 2 Summary of procedures performed during the study visits. The study divided into three phases; screening, treatment and post-screening phase which distributed into 11 visits where each visit had certain evaluation measurements

From: A prospective, single-centre, single-arm, open label study of the long term use of a gonadotropin releasing hormone agonist (Triptorelin SR, 11.25 mg) in combination with Tibolone add-back therapy in the management of chronic cyclical pelvic pain

 Screening phaseTreatment 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 ScreenVisit 22Visit 3Visit 4Visit 5Visit 6Visit 7Visit 8Visit 9Visit 10Visit 11
Written informed consentX          
Medical historyX          
History of CCPPX          
Physical examination X       XX
Vital signs 5XX   X   XX
Urine pregnancy test X         
Review of Inclusion / Exclusion CriteriaXX         
Enrolment in the study X         
Bone density (DEXA)X    X   XX
CPG questionnaire X X X X XX
EHP-30 questionnaire X X X X XX
Blood samples for haematology and biochemistryX    X   XX
Triptorelin injection XXXXXXXX  
Dispense Tibolone XXXXXXXX  
Tibolone compliance checked  XXXXXXXX 
Dispense patient diaryXXXXXXXXXX 
Collect patient diary XXXXXXXXXX
Prior and concomitant medicationsXXXXXXXXXXX
Adverse events XXXXXXXXXX
End of study details          X
  1. 1 Screening was conducted up to 2-months prior to the baseline visit. Screening and baseline visits were combined if the results of the DEXA scan were available for review prior to enrolment.
  2. 2 The baseline visit took place in the late luteal phase of the patient’s menstrual cycle.