Evaluation of a 91-day extended-regimen oral contraceptive compared to a conventional 28-day regimen for the treatment of cyclic pelvic pain

Abstract

OBJECTIVE: To evaluate the effects of a 91-day extended regimen oral contraceptive (OC) compared to a 28-day OC regimen in women with moderate to severe menstrual-related (cyclic) pelvic pain. DESIGN: In this double-blind, multicenter trial, a total of 175 women, aged 18-40 years with a history of moderate to severe menstrual-related pelvic pain for 3 consecutive menstrual cycles or a minimum of 4 of their 6 previous menstrual cycles, and who demonstrated moderate or severe menstrual-related pain during an observation cycle, were randomized to receive either 2 consecutive 91-day cycles of an extended regimen OC (150 micrograms [mcg] levonorgestrel [LNG]/30 mcg ethinyl estradiol [EE] for 84 days followed by 7 days of 10 mcg EE alone; n=93) or six consecutive 28-day cycles of 150 mcg LNG/30 mcg EE for 21 days followed by 7 days of placebo; n=82). MATERIALS AND METHODS: Five symptoms (dysmenorrhea, dyspareunia, pelvic pain, pelvic tenderness, and induration) were evaluated using the Biberoglu and Behrman (B&B) Symptom Severity Scale. Each symptom was evaluated using a 4-point scale (0=none, 1=mild, 2=moderate, 3=severe). RESULTS: Both groups showed a reduction in severity of dysmenorrhea and pelvic pain from baseline to the end of the study. Statistically significant reductions in the severity of dysmenorrhea were observed for the 91-day group compared to the 28-day group during weeks 4 and 12. At the end of the study, 14.7% of subjects on the 91-day regimen still reported moderate-to-severe dysmenorrhea compared to 27.5% of subjects on the 28-day group regimen. For both groups, minimal reductions in severity were observed for dyspareunia, pelvic tenderness, and induration. There were fewer reported days of moderate-to-severe abdominal/pelvic pain and pain medication use in subjects randomized to the 91-day regimen. CONCLUSIONS: Both 91-day and 28-day OC regimens are effective in reducing the severity of dysmenorrhea. Use of the extended regimen OC may provide an earlier “onset of relief” and may lead to a greater, more sustained reduction in the number of days of moderate-to severe pelvic pain and fewer days requiring the use of pain medication.