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Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen.
Eur J Contracept Reprod Health Care. 2011 Dec; 16(6):430-43.EJ

Abstract

OBJECTIVES

The primary objective was to assess the efficacy, cycle control and tolerability of a monophasic combined oral contraceptive (COC) containing nomegestrol acetate (NOMAC) and 17β-oestradiol (E2). Effects on acne were evaluated as a secondary objective. Results were compared to those of a COC containing drospirenone (DRSP) and ethinylestradiol (EE).

METHODS

Women (aged 18-50 years) were randomised to receive NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n=1591) or DRSP/EE (3 mg/30 μg) in a 21/7-day regimen (n=535) for 13 cycles.

RESULTS

Estimated Pearl Indices for NOMAC/E2 and DRSP/EE were 0.38 and 0.81 in women aged≤35 years and 0.31 and 0.66 for all women (18-50 years), respectively. Scheduled withdrawal bleedings were shorter and lighter among users of NOMAC/E2 and were sometimes absent altogether. Intracyclic bleeding/spotting was infrequent in both groups, and decreased over time. Type and frequency of adverse events were similar to those typically reported for COCs.

CONCLUSIONS

These data show that NOMAC/E2 provides high contraceptive efficacy with acceptable cycle control as well as an overall adverse event profile similar to that of DRSP/EE.

Authors+Show Affiliations

Sexual Health Services, Newcastle Hospitals Community Health, Newcastle upon Tyne, UK. Diana.Mansour@newcastle-pct.nhs.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21995590

Citation

Mansour, Diana, et al. "Efficacy and Tolerability of a Monophasic Combined Oral Contraceptive Containing Nomegestrol Acetate and 17β-oestradiol in a 24/4 Regimen, in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Drospirenone in a 21/7 Regimen." The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception, vol. 16, no. 6, 2011, pp. 430-43.
Mansour D, Verhoeven C, Sommer W, et al. Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen. Eur J Contracept Reprod Health Care. 2011;16(6):430-43.
Mansour, D., Verhoeven, C., Sommer, W., Weisberg, E., Taneepanichskul, S., Melis, G. B., Sundström-Poromaa, I., & Korver, T. (2011). Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen. The European Journal of Contraception & Reproductive Health Care : the Official Journal of the European Society of Contraception, 16(6), 430-43. https://doi.org/10.3109/13625187.2011.614029
Mansour D, et al. Efficacy and Tolerability of a Monophasic Combined Oral Contraceptive Containing Nomegestrol Acetate and 17β-oestradiol in a 24/4 Regimen, in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Drospirenone in a 21/7 Regimen. Eur J Contracept Reprod Health Care. 2011;16(6):430-43. PubMed PMID: 21995590.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17β-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen. AU - Mansour,Diana, AU - Verhoeven,Carole, AU - Sommer,Werner, AU - Weisberg,Edith, AU - Taneepanichskul,Surasak, AU - Melis,Gian Benedetto, AU - Sundström-Poromaa,Inger, AU - Korver,Tjeerd, Y1 - 2011/10/13/ PY - 2011/10/15/entrez PY - 2011/10/15/pubmed PY - 2012/4/6/medline SP - 430 EP - 43 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 - 16 IS - 6 N2 - OBJECTIVES: The primary objective was to assess the efficacy, cycle control and tolerability of a monophasic combined oral contraceptive (COC) containing nomegestrol acetate (NOMAC) and 17β-oestradiol (E2). Effects on acne were evaluated as a secondary objective. Results were compared to those of a COC containing drospirenone (DRSP) and ethinylestradiol (EE). METHODS: Women (aged 18-50 years) were randomised to receive NOMAC/E2 (2.5 mg/1.5 mg) in a 24/4-day regimen (n=1591) or DRSP/EE (3 mg/30 μg) in a 21/7-day regimen (n=535) for 13 cycles. RESULTS: Estimated Pearl Indices for NOMAC/E2 and DRSP/EE were 0.38 and 0.81 in women aged≤35 years and 0.31 and 0.66 for all women (18-50 years), respectively. Scheduled withdrawal bleedings were shorter and lighter among users of NOMAC/E2 and were sometimes absent altogether. Intracyclic bleeding/spotting was infrequent in both groups, and decreased over time. Type and frequency of adverse events were similar to those typically reported for COCs. CONCLUSIONS: These data show that NOMAC/E2 provides high contraceptive efficacy with acceptable cycle control as well as an overall adverse event profile similar to that of DRSP/EE. SN - 1473-0782 UR - https://www.unboundmedicine.com/medline/citation/21995590/Efficacy_and_tolerability_of_a_monophasic_combined_oral_contraceptive_containing_nomegestrol_acetate_and_17β_oestradiol_in_a_24/4_regimen_in_comparison_to_an_oral_contraceptive_containing_ethinylestradiol_and_drospirenone_in_a_21/7_regimen_ L2 - http://www.tandfonline.com/doi/full/10.3109/13625187.2011.614029 DB - PRIME DP - Unbound Medicine ER -