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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 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

  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.