|
| 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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