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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.
Eur J Contracept Reprod Health Care. 2017 Feb; 22(1):11-16.EJ

Abstract

OBJECTIVES

The aim of the study was to assess the efficacy for menstrual-related symptoms of an extended flexible regimen of an oral contraceptive pill containing 20 μg ethinylestradiol and 3 mg drospirenone in comparison with a 24/4 d cyclical regimen of the same formulation.

METHODS

This randomised, non-inferiority, open-label, multicentre study was conducted in women aged 18-39 years. Their menstrual-related symptoms were assessed using the Penn Daily Symptom Rating (DSR17). Participants were randomised to use an extended flexible regimen of 20 μg ethinylestradiol and 3 mg drospirenone (EE/DRSPe.flex), comprising 168 consecutive days with a 4-d hormone-free interval (HFI, allowing for management of unexpected bleeding) or a conventional 24/4 cyclical regimen of the same pill (EE/DRSP24/4). The primary measure of efficacy was the percentage change in DSR17 total score from baseline to cycle 6. The secondary measures of efficacy were the percentage changes in DSR17 total score from baseline after each 28-d interval throughout the entire study and in the scores for individual DSR17 symptoms.

RESULTS

The primary analysis demonstrated that EE/DRSPe.flex was not inferior to EE/DRSP24/4 (Mean DSR17 score 9.1; 95% confidence interval (CI) - 2.5, 20.6; p = 0.123). Analysis at intervals throughout the entire evaluation period showed greater reduction in DSR17 total score for EE/DRSPe.flex than for the 24/4 regimen (p < 0.001). The decreases in individual scores for the symptoms 'poor coordination' and 'depression/feeling sad/down or blue' were greater for the extended flexible regimen than for the cyclical regimen (p < 0.05).

CONCLUSION

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.

Authors+Show Affiliations

a Department of Gynaecology and Obstetrics , Jundiaí School of Medicine , Jundiaí , Brazil.b Department of Gynaecology and Obstetrics , ABC School of Medicine , Santo André , Brazil.c Department of Gynaecology and Obstetrics , PUC-RS, Porto Alegre , Brazil.d Department of Gynaecology and Obstetrics , University of São Paulo (FMRP-USP) , Ribeirão Preto , Brazil.e Department of Clinical Research , Libbs Farmacêutica Ltda , São Paulo , Brazil.f Department of Gynaecology and Obstetrics , Botucatu School of Medicine (FMB-UNESP), UNESP - Sao Paulo State University , Botucatu , Brazil.g Centre for Research and Assistance in Human Reproduction , Federal University of Bahia , Salvador , Brazil.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27684740

Citation

Machado, Rogério Bonassi, et al. "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." The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception, vol. 22, no. 1, 2017, pp. 11-16.
Machado RB, Pompei LM, Badalotti M, et al. 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. Eur J Contracept Reprod Health Care. 2017;22(1):11-16.
Machado, R. B., Pompei, L. M., Badalotti, M., Ferriani, R., Cruz, A. M., Nahas, E., & Maia, H. (2017). 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. The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception, 22(1), 11-16. https://doi.org/10.1080/13625187.2016.1239077
Machado RB, et al. 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. Eur J Contracept Reprod Health Care. 2017;22(1):11-16. PubMed PMID: 27684740.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Machado,Rogério Bonassi, AU - Pompei,Luciano Melo, AU - Badalotti,Mariangela, AU - Ferriani,Rui, AU - Cruz,Achilles M, AU - Nahas,Eliana, AU - Maia,Hugo,Jr Y1 - 2016/09/29/ PY - 2016/9/30/pubmed PY - 2017/6/18/medline PY - 2016/9/30/entrez KW - Combined oral contraceptives KW - drospirenone KW - extended regimen KW - low-dose oral contraceptive KW - premenstrual symptoms SP - 11 EP - 16 JF - The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception JO - Eur J Contracept Reprod Health Care VL - 22 IS - 1 N2 - OBJECTIVES: The aim of the study was to assess the efficacy for menstrual-related symptoms of an extended flexible regimen of an oral contraceptive pill containing 20 μg ethinylestradiol and 3 mg drospirenone in comparison with a 24/4 d cyclical regimen of the same formulation. METHODS: This randomised, non-inferiority, open-label, multicentre study was conducted in women aged 18-39 years. Their menstrual-related symptoms were assessed using the Penn Daily Symptom Rating (DSR17). Participants were randomised to use an extended flexible regimen of 20 μg ethinylestradiol and 3 mg drospirenone (EE/DRSPe.flex), comprising 168 consecutive days with a 4-d hormone-free interval (HFI, allowing for management of unexpected bleeding) or a conventional 24/4 cyclical regimen of the same pill (EE/DRSP24/4). The primary measure of efficacy was the percentage change in DSR17 total score from baseline to cycle 6. The secondary measures of efficacy were the percentage changes in DSR17 total score from baseline after each 28-d interval throughout the entire study and in the scores for individual DSR17 symptoms. RESULTS: The primary analysis demonstrated that EE/DRSPe.flex was not inferior to EE/DRSP24/4 (Mean DSR17 score 9.1; 95% confidence interval (CI) - 2.5, 20.6; p = 0.123). Analysis at intervals throughout the entire evaluation period showed greater reduction in DSR17 total score for EE/DRSPe.flex than for the 24/4 regimen (p < 0.001). The decreases in individual scores for the symptoms 'poor coordination' and 'depression/feeling sad/down or blue' were greater for the extended flexible regimen than for the cyclical regimen (p < 0.05). CONCLUSION: 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. SN - 1473-0782 UR - https://www.unboundmedicine.com/medline/citation/27684740/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_ L2 - http://www.tandfonline.com/doi/full/10.1080/13625187.2016.1239077 DB - PRIME DP - Unbound Medicine ER -