Significant improvement in cycle-related symptoms following
treatment with continuous LNG/EE, a low-dose continuous oral contraceptive.
EW Freeman1, H Borisute2, L Deal2, L Smith2, G Grubb2, G
Constantine2
1University of Pennsylvania, Department of Obstetrics and
Gynecology, Philadelphia, PA, United States, 2Wyeth Research, Collegeville, PA,
United States
Objective Cycle-related symptoms (CRS) and work
productivity were evaluated during the first 3 pill packs of continuous LNG/EE
(levonorgestrel 90 µg/ethinyl estradiol 20 µg), a novel low-dose continuous
oral contraceptive (OC).
Study design and methods Women aged 18 to 49 years with a
3-month history of regular menstrual cycles who were healthy and sexually active,
with a history of premenstrual syndrome (PMS) or milder cyclic symptoms and/or
dysmenorrhea, who were not using antidepressants or anxiolytics, were enrolled
in a substudy of a phase 3, single-treatment, open-label, 1-year trial of
continuous LNG/EE taken daily for 12 months (13 pill packs) with no pill-free
intervals. CRS were assessed daily at baseline and during the first 3 pill packs
of study drug using the Penn Daily Symptom Rating (DSR) scale, a 17-item
validated tool with 4 subscales (mood, behavior, pain, and physical), and
summarized for the premenstrual (last 6 days [ie, days 23-28]) of the baseline
cycle and each pill pack) and postmenstrual (days 6-11 of each cycle or pill
pack) periods. For dysmenorrhea, scores from the first 5 days of the baseline
cycle were compared with those from the first 5 days of each pill pack. Work
productivity was evaluated using the Endicott Work Productivity Scale (EWPS) for
women with PMS (using week 4 scores) or dysmenorrhea (week 1 scores).
Results Among women with PMS (n = 78), the mean
premenstrual total Penn DSR score at baseline was 143.7 ± 56.2, and was
significantly decreased during all 3 pill packs of continuous LNG/EE (60.6 ±
58.4, 42.5 ± 43.6, and 28.4 ± 38.8 during pill packs 1, 2, and 3, respectively;
P <0.001 for all). Premenstrual Penn DSR scores for all subscales also significantly improved (P <0.001) from baseline. In addition, mean total postmenstrual Penn DSR scores increased at all 3 pill packs (P <0.001 for all). Women with milder cyclic symptoms (n = 36) reported similar improvements in their symptoms. Women with dysmenorrhea (n = 259) experienced a significant improvement in Penn DSR scores for cramps during all 3 pill packs (P <0.001 for all). As symptoms improved, work productivity increased; EWPS scores improved significantly from baseline (P <0.001) with each pill pack.
Conclusion Continuous LNG/EE is the first low-dose
continuous OC that has been shown to significantly improve CRS, as well as work
productivity.