SAMBA Study
Research status
Completed
Overview of Study
A phase 3 premarketing study of a combined pill containing a new progestogen: nomogestrel acetate and oestradiol a less potent oestrogen compared to a marketed COC- Yasmin. This was a randomised open-label comparative multi-centre trial to evaluate contraceptive efficacy, cycle control, safety and acceptability.
Objectives of study
Following screening to assess eligibility women were randomly allocated to one of the COC’s. They kept a computerised diary recording pill intake, bleeding patterns and side effects during the study. Participants also completed the following questionnaires at various points during the study: shortened Quality of Life Enjoyment and Satisfaction, McCoy female sexuality questionnaire and Moos Menstrual Distress questionnaire.