DESIGN: A case-controlled study of the iron levels (microgram/mL) in the pelvic PF of 12 patients with moderate-to-severe disease, 15 patients with minimal-to-mild disease and in 17 women with normal pelvises were compared. As an index of free radical reactions through lipid peroxidation, the levels of malondialdehyde levels (ng/mL) were assessed simultaneously in the same specimens.
RESULTS: Controlling for the phase of the menstrual cycle, significantly higher levels of iron were seen in patients with endometriosis, the levels being correlated with the severity of the disease. However no such corresponding relationship was seen in the malondialdehyde levels in the PF.
CONCLUSIONS: These results suggest that raised iron levels in the PF do not play a role in catalyzing free radical reactions as judged by the degree of lipid peroxidation.
DESIGN: Control study involving patients with and without endometriosis.
METHODS: The lipid peroxide (malondialdehyde) levels in the pelvic PF of 12 patients with moderate-to severe endometriosis, 15 patients with minimal-mild endometriosis and 13 patients with normal pelvises were compared.
RESULTS: The level of lipid peroxides were not affected by the presence nor the severity of endometriosis.
CONCLUSION: Accelerated lipid peroxidation does not appear to play a role in the causal relationship between endometriosis and infertility.
METHODS: Asian women received dienogest (2 mg/daily) and were followed for 24 months. The effectiveness of dienogest to improve HRQoL and endometriosis-associated pelvic pain (EAPP) was assessed by patient-reported outcomes. HRQoL, especially the "pain" domain as primary endpoint, was evaluated with the Endometriosis Health Profile-30 (EHP-30) questionnaire. The numeric rating scale served to determine changes in the severity of EAPP. Within the presented interim analysis (data cut-off: 2017-11-27), the mean changes in EHP-30 and EAPP scores from baseline to 6 months upon availability of the data were evaluated. Treatment-emergent adverse events (TEAEs) and bleeding profiles were documented.
RESULTS: Dienogest therapy decreased EHP-30 scores in all assessed domains (score 0-100, lower scores indicate better HRQoL). Primarily, the "pain" domain was improved in 78.4% of patients. EAPP was reduced (score 0-10, lower scores reflect less pain), highlighted by a mean reduction of the pain score by - 4.5 points. Patients with a higher EAPP score at baseline had an increased response to dienogest (- 6.2 points mean change) compared to patients with low baseline EAPP severity (- 1.4 points mean change). Both surgically and clinically diagnosed patients described comparable pain reduction, as well as women with or without prior treatment. Drug-related TEAEs were documented for 31.5% of patients, with amenorrhoea (5.9%) and metrorrhagia (5.1%) being the most common events. The bleeding pattern was changed upon dienogest, characterized by decreased normal bleeding (84.2 to 28.8%) and increased amenorrhea (3.2 to 42.9%) at 6 months.
CONCLUSION: The data indicate an amelioration of HRQoL and EAPP upon dienogest therapy. No new safety signals were observed. Therefore, its use as first-line therapy for long-term management of debilitating and chronic endometriosis-associated pain represents an interesting option that remains to be further investigated.
TRIAL REGISTRATION: Name of registry: Clinical Trials Clinicaltrials.gov registration number: NCT02425462 Registration date: 2015-04-24. Registration timing: prospective.