Efficacy and safety of a new 24-day oral contraceptive regimen of norethindrone acetate 1 mg/ethinyl estradiol 20 micro g (Loestrin 24 Fe)

New low-dose formulations of combination oral contraceptives (COCs) are safe and effective, but they may be associated with an increased risk of breakthrough bleeding. Extending the duration of active hormonal treatment may reduce the frequency of intracyclic bleeding/spotting while maintaining effi...

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Bibliographic Details
Published in:Contraception (Stoneham) 2007-01, Vol.75 (1), p.16
Main Authors: Nakajima, Steven T, Archer, David F, Ellman, Herman
Format: Article
Language:English
Subjects:
Adolescent
Adult
Contraceptives, Oral, Combined - adverse effects
Contraceptives, Oral, Combined - therapeutic use
Contraceptives, Oral, Synthetic - adverse effects
Contraceptives, Oral, Synthetic - therapeutic use
Dose-Response Relationship, Drug
Estradiol - adverse effects
Estradiol - therapeutic use
Female
Humans
Menstrual Cycle - drug effects
Menstrual Cycle - physiology
Metrorrhagia - chemically induced
Metrorrhagia - epidemiology
Middle Aged
Norethindrone - adverse effects
Norethindrone - analogs & derivatives
Norethindrone - therapeutic use
Pregnancy
Pregnancy Rate
Risk Assessment
Safety
Time Factors
Treatment Outcome
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Summary:New low-dose formulations of combination oral contraceptives (COCs) are safe and effective, but they may be associated with an increased risk of breakthrough bleeding. Extending the duration of active hormonal treatment may reduce the frequency of intracyclic bleeding/spotting while maintaining efficacy and tolerability. This 6-month, open-label, randomized, active-controlled study involved healthy women aged 18-45 years who were at risk for pregnancy. Women were randomized 4:1 to a 24-day regimen of norethindrone acetate 1 mg/ethinyl estradiol 20 micro g (NETA/EE-24) or to a 21-day regimen of the same combination (NETA/EE-21). The outcomes assessed included pregnancy and incidence, duration of bleeding and intensity of bleeding. The cumulative risk of pregnancy in the NETA/EE-24 group (n=705) was 0.9% during six cycles of treatment. Compared with NETA/EE-21 (n=181), NETA/EE-24 was associated with significantly fewer intracyclic bleeding days (0.95 vs. 1.63; p=.005), fewer days of withdrawal bleeding (2.66 vs. 3.88; p
ISSN:0010-7824