Source: Neuroimaging Clin N Am  |  Posted 6 years ago

By Amanda Strong

MONTREAL, QC -- October 18, 2005 -- Menstrual cycle-related symptoms can be improved with a continuous-use, low-dose, oral contraceptive regimen, according to data from a substudy of a large phase 3 clinical trial.

In a continuous regimen, the contraceptive is taken every day for a full year without any hormone-free interval. The results were presented here on October 17[^]th[] at the American Society for Reproductive Medicine (ASRM) Annual Meeting and Conference.

"As far as I know it is the first study that actually looks at continuous-use oral contraceptives in PMS [premenstrual syndrome] and cycle related symptoms, although I think doctors are doing it already," said presenter Ellen W. Freeman, PhD, Research Professor, Department of Obstetrics and Gynecology and Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, United States.

For the study, 72 women with a history of menstrual cycle-related symptoms (CRS) or dysmenorrhea took a continuous regimen of 90 mcg levonorgestral plus 20 mcg ethinyl estradiol for a duration of three pill packs, or approximately 84 days. Subjects were then divided using predefined criteria into 3 groups according to their symptoms: PMS (severe premenstrual symptoms), milder cycle-related symptoms, and dysmenorrhea.

Symptoms in each group were assessed using the Penn Daily Symptom Rating (DSR) diary, which included 4 subscales for mood, behaviour, pain, and physical symptoms. Work productivity was also recorded using the Endicott Work Productivity Scale (EWPS).

In the PMS group, there was a rapid decrease from baseline in the premenstrual score daily symptom rating by the first pill pack (P < .001), with much smaller, incremental decreases at the second and third pill packs. By the third pill pack, premenstrual scores had approached those of postmenstrual scores (P < .001).

From a clinical perspective, 67% of women in the PMS group improved at least 50% from baseline at the first pill pack, increasing to 78% and 89% by the second and third pill packs, respectively. Similar improvements were seen across all subscales (P < .001) and recorded symptoms. A similar, statistically significant set of improvements was also seen in the group with milder CRS symptoms.

The pattern in the dysmenorrhea group was slightly different from the other two groups. Benefits were evident by the second pill pack instead of the first, with mean decreases from baseline in cramp scores of 71% and 85% by the second and third pill packs, respectively (P < .001).

Work productivity scores were also improved from baseline at pill pack 1 (P < .001) and were highly correlated with symptom scores in all groups -- as symptom scores decreased, EWPS scores increased. Mean increases in EWPS scores from baseline were 37% and 53% in the PMS and dysmenorrhea groups, respectively.

"The impact of cycle-related symptoms is well known" said Dr Freeman. "There is an impact on quality of life. Women with PMS report higher absentee rates from work, lower productivity, impairment in their routine work, home or school activities, and most of all, they report difficulty in their relationships between their partner, children or work colleagues."

This study demonstrates that cycle-related symptoms can be improved using a continuous-use oral contraceptive regimen, potentially resulting in improved work productivity, Dr. Freedman concluded.

This treatment option might be of interest to women seeking relief from premenstrual symptoms as well as contraception, the researchers concluded.

The study was supported by Wyeth Research, Collegeville, Pennsylvania, manufacturers of leonorgestral/ethinyl estradiol under the tradename Lybrel(R). A new drug application (NDA) for Lybrel has been submitted to the U.S. Food and Drug Administration (FDA) and is currently under review.

[Presentation title: A Continuous-Use Regimen of Levonorgestrel/Ethinyl Estradiol Significantly Alleviates Cycle-Related Symptoms: Results of a Phase 3 Study. Abstract O-59]