Effects of an extended flexible regimen of an oral contraceptive pill containing 20 μg ethinylestradiol and 3 mg drospirenone on menstrual-related symptoms: a randomised controlled trial

Abstract

The extended flexible regimen was not inferior to the 24/4 cyclical regimen in terms of the primary endpoint. It significantly improved symptoms in the interval analysis, and the effects on specific DSR17 symptoms, compared with the cyclical regimen.

<p>Bleeding Pattern and Management of Unexpected Bleeding/Spotting with an Extended Regimen of a Combination of Ethinylestradiol 20 mcg and Drospirenone 3 mg</p>

“…This was a randomized, open-label, multicenter study constituting part of the main study with the primary objective of evaluating menstrual-related symptoms in women using a contraceptive containing ethinylestradiol 20 mcg and drospirenone 3 mg in an extended flexible regimen or a 24/4 cyclic regimen (24/4). 11 The 11 Brazilian sites (Jundiaí School of Medicine) (RB Machado), ABC School of Medicine (LM Pompei), Federal University of Parana (R Andrade), Botucatu Medical School (Unesp) (E Nahas), Federal University of Sao Paulo (C Guazzelli), Federal University of Rio Grande do Sul (MC Wender), Centro de Pesquisa e Assistência em Reprodução Humana (CEPARH) (H Maia Filho), University of Sao Paulo -Ribeirao Preto (RA Ferriani), PUC Rio Grande do Sul (M Badalotti), Centro Paulista de Investigaçao Clinica (S Del Debio), Endocrinology Unit Federal University of Sao Paulo (M Lazaretti Castro) involved in the study obtained approval from their respective Research Ethics Committees. All women volunteered to participate in the study, after detailed information was provided and the informed consent form was signed, according to the Declaration of Helsinki.…”

“…The sample size was calculated from the primary efficacy parameter (mean percent decrease in the total symptom score assessed by the Penn Daily Symptom Report), which is the primary objective of the published study. 11 Considering an expected improvement of 50% from baseline, a power of 80%, a significance level of 5%, and a non-inferiority margin of 15%, 276 patients were supposed to complete the study, assuming a standard deviation of 50%. Considering a 25% dropout rate, at least 368 women were supposed to be enrolled in the study.…”

Premenstrual disorders: Premenstrual syndrome and premenstrual dysphoric disorder

“…33 There are reports suggesting the effectiveness of sequential dosing. 79,80 GnRH agonists suppress ovulation and improve the PMS symptoms. 81,82 Low estrogen status results in symptoms of vasomotor symptoms, bone loss, and vaginal atrophy, similar to those seen after menopause, requiring estrogen add-back.…”

“…Continuous dosing regimens are advantageous for improving premenstrual symptoms because they eliminate the hormone‐free period compared with regimens with classical withdrawal periods 33 . There are reports suggesting the effectiveness of sequential dosing 79,80 …”