INTRODUCTION: Patient satisfaction often impacts patient adherence to treatment. The purpose of this study was to develop and validate a treatment satisfaction questionnaire that may be used for a variety of trials with menopausal women. METHODS: Interviews with menopausal women (N=62, UK, Germany, Netherlands, US and Canada) served as the basis for the development of a treatment satisfaction module (TSM). In-depth literature reviews and clinician interviews were also conducted. The face and content validity of the TSM was subsequently tested on 69 menopausal women taking HRT. Finally, the questionnaire was psychometrically validated in a cross-sectional study in the US and Canada on 100 menopausal women currently taking HRT. RESULTS: Interviews resulted in a core set of 14 items developed to assess treatment effectiveness, satisfaction, expectations, and behaviours. The validation study resulted in the deletion of 1 item regarding patient knowledge about treatment. The remaining 13 items yielded three factors: treatment satisfaction, adherence/compliance and side effects. The TSM was reliable (alpha>0.70) for all scales. In addition, patients who experienced post-menopausal bleeding were less satisfied than those who did not experience post-menopausal bleeding, indicating the preliminary validity of the TSM. CONCLUSION: The TSM is currently being used in clinical trials and further research will be conducted on the predictive validity of the questionnaire in predicting dropouts from clinical trials. Although the TSM was developed with women, the questions were worded in a generic and gender-neutral manner. Thus, it is intended that the TSM be used and validated in a variety of trials and conditions.