General Obstetrics and Gynecology: Gynecology
Oral contraceptives and premenstrual symptoms: Comparison of a 21/7 and extended regimen

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Objective

The purpose of this study was to assess the incidence and severity of premenstrual-type symptoms in patients converted from a 21/7 oral contraceptive (OC) regimen to an extended regimen.

Study design

This was a single center prospective analysis of the single item Scott and White (S&W) Mood Scale and the Penn State Daily Symptom Report (DSR17) during a 21/7-day followed by a 168-day extended regimen of an OC containing 3 mg of drosperinone and 30 μg of ethinyl estradiol (DRSP/EE).

Results

Of the 114 patients who began the study, 111 completed the preextension 21/7 phase of the study. There were significant differences in severity in the DSR17 and the S&W mood scale among days of the cycle. (P < .0001) The highest values in both scales occurred during the 7-day hormone free interval (HFI) of the 21/7 cycles (P < .001). Of the 111 patients who completed the 21/7 phase of the study, 102 (92%) completed the 168-day extended regimen. During the extended phase of the study, subjects were divided into 2 groups: those with a 100% increase in symptoms from the first half to the second half of the last 21/7 cycle were labeled as high cyclic variability, whereas those with lesser or no cyclic change were labeled as low cyclic variability. There were 55 (54%) with increased cyclic variability in mood scores peaking during the 7-day HFI. Premenstrual-type symptoms measured by both the S&W mood scale and the DSR17 instrument decreased during the extended DRSP/EE OC regimen (P < .0001) compared with the preceding 21/7 cycle, with the greatest improvement detected in the sixth month of continuous OCs (P < .003). The patient group with greatest cyclic variability during the 21/7 regimen demonstrated the most improvement during the 168-day regimen (P < .0001). The single item S&W mood scale was significantly (P < .05) correlated to each of 17 elements of the DSR17 with Spearman R correlation coefficients of 0.25 to 0.57. The greatest correlation coefficient (Spearman's R = 0.66) is with the sum of all 17 items.

Conclusion

A 168-day extended regimen of DRSP/EE led to a decrease in premenstrual-type symptoms compared with the 21/7-day regimen.

Section snippets

Material and methods

This single center, prospective cohort study was approved by the Scott & White Institutional Review Board and written informed consent was obtained. At study entry, all subjects were current combination OC users of at least 3 months' duration, between the ages of 18 and 48. They had no contraindications to continuing OCs, including no history of myocardial infarction, stoke, uncontrolled hypertension, venous thromboembolic events, breast cancer, diabetes mellitus, and liver disease.

Results

Of the 114 patients who entered the study, 111 completed the 21/7-phase study and 102 completed the extended phase requirements including both daily scoring instruments. Fifty-four of 102 subjects completing the study were on a 19-nortestosterone containing progestin OC when they entered the study while the remainder were on DRSP/EE at study initiation. Patients entering the study on DRSP/EE OCs did not statistically differ (P = .34) in DSR 17 scores of their initial cycle (6.8 ± 0.9 for mean ±

Comment

The present study confirms that many women experience a multitude of premenstrual type symptoms while utilizing standard 21/7 OCs. Regardless of the progestin content of the pill, symptoms worsen during the last week of active pills, peaking in intensity during the 7-day HFI. The occurrence and severity of symptoms interestingly coincides with the decline in endogenous estradiol levels during the last week of active pills into the beginning of the HFI.9, 10 While occurrence and severity of

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Funding provided by Berlex Laboratories, Montville, NJ.

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