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Entry criteria | |
Surgical diagnosis of endometriosis in the last 5 years | |
Pain symptoms | |
Data capture at baseline: | |
(i) ASRM staging | |
(ii) baseline pain scores over at least 2 menstrual cycles | |
(iii) EHP-30 | |
(iv) previous treatments and responses | |
|
Primary outcome measures | |
Daily ratings of pelvic pain | |
Daily ratings of dysmenorrhea | |
Ratings on an 11-point NRS | |
|
Secondary outcome measures | |
B & B with separate scores for each domain, administered weekly for 6 weeks, then monthly until 6 months, and then at 9, 12, 18, and 24 months | |
EHP-30 with separate and total scores, administered at the same tie points as the B & B | |
Use of rescue analgesia/therapies including an NRS before us and a record of the indication | |
Study specific adverse event questionnaires with direct questions and free text, administered at the same time points as the B & B | |
Detailed information as per the CONSORT guidelines, including | |
(i) the recruitment process | |
(ii) the number of participants who were excluded and why | |
(iii) the number of candidates who chose not to enter the trial and why | |
(iv) the use of prohibited concomitant mediations and other protocol deviations | |
(v) the number and reasons for withdrawal from each treatment group | |
(vi) the types rates and reasons for nonadherence with treatment in each group | |
|
Tertiary outcome measures | |
Daily NRS of three symptoms the patient feels are important for her, for example, dyspareunia, dyschezia, fatigue, and so forth | |
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