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Evaluating the efficacy of an oral contraceptive among an adolescent cohort

Objective

A Phase III study to evaluate the safety of an oral contraceptive in adolescents aged 12 to 17.

Methodology

ObvioHealth designed this study using hybrid modules to include six site visits combined with ePRO—using the ObvioHealth ap—to monitor patients in between visits.  

Due to the number of questionnaires required for this study, ObvioHealth needed to design its ePRO instruments to be as intuitive as possible for patients. An easy user-experience, as well as push notifications to remind patients to complete questionnaires, will help to facilitate compliance. eDiaries will record:  

  • Daily tablet intake and absence or occurrence of vaginal bleeding/spotting event(s)  
  • The occurrence of heterosexual intercourse, the use of other contraceptive methods, and the results of urine pregnancy tests performed at home
  • The physical, psychological, and social well-being of the patients  
  • Pain associated with menstrual cycles  

Safety is evaluated by analyzing the number, frequency, type, and intensity of TEAEs, routine laboratory parameters, vital signs, ECG, physical, gynecological, and breast examination findings.

Results

This study is ongoing, with nearly half of the 100 patients enrolled.

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