Qlaira&lt;SUP&gt;®&lt;/SUP&gt;: a 'natural' change of direction

Mansour, Diana

doi:10.1783/147118909788707878

Cited by 16 publications

(9 citation statements)

References 12 publications

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“…E 2 V/DNG was found to be as effective in women age 25 as age 35. 51 The Kaplan-Meier estimate of contraceptive failure at the end of 1 year was 0.010 and the cumulative failure rate for the full 20 cycles was 0.0142 (95% CI: 0.0080-0.251) for women 18-35 years. Overall, 79.5% of subjects were satisfied or very satisfied with their therapy.…”

Section: If You Are Still Not Sure Of What To Do About the Pills You mentioning

confidence: 93%

“…The duration of scheduled bleeding episodes with E 2 V/ DNG was 4.5 days; with the EE/LNG pills, the duration was 5.1 days (P , 0.05). 51,53 Significantly more women rated their scheduled bleeding as "spotting" or "light" with the E 2 V/ DNG formulation (P , 0.0001) (see Figure 2). Amenorrhea rates were also significantly higher (19.4% vs 7.7%) among E 2 V/DNG users (P , 0.0001).…”

Section: Bleeding Profilesmentioning

confidence: 99%

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New developments in oral contraception: clinical utility of estradiol valerate/dienogest (Natazia®) for contraception and for treatment of heavy menstrual bleeding: patient considerations

Nelson¹

2012

OAJC

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Natazia ® is a new oral contraceptive with estradiol valerate and dienogest in a unique multiphasic formulation that includes a shortened hormone-free interval. This new formulation has been approved for both contraception and also as a treatment for heavy menstrual bleeding in women who desire to use oral contraceptives as their method of birth control. It is marketed in the US as Natazia ® and elsewhere as Qlaira ® . This article will review the properties of each of the major new features of this pill: estradiol used in place of ethinyl estradiol, dienogest as the progestin, and the unique dosing pattern of this product. It will also summarize the results of the pivotal clinical trials of contraceptive effectiveness, bleeding patterns, safety and tolerability. The lessons learned from the clinical trials about the effectiveness of this formulation in the treatment of excessive menstrual bleeding will be summarized. Also, results of trials comparing this new pill to other popular formulations for "menstrually-related" symptoms and for potential female sexual dysfunction related to use of oral contraceptives will be presented. This review will suggest how all this information might be used to counsel women about how to use this pill most successfully.

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Section: If You Are Still Not Sure Of What To Do About the Pills You mentioning

confidence: 93%

Section: Bleeding Profilesmentioning

confidence: 99%

New developments in oral contraception: clinical utility of estradiol valerate/dienogest (Natazia®) for contraception and for treatment of heavy menstrual bleeding: patient considerations

Nelson¹

2012

OAJC

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“…90,91 Similarly, premenopausal women who are concerned about the effects of exogenous hormones may be at greater ease using COCs containing 'natural' hormones. 92 Initial attempts to substitute EE with estradiol were largely unsuccessful, as these COCs were associated with poor cycle control. 18,19,[93][94][95] For example, in a study comparing two formulations that contained the same progestogen but different estrogens, more women using the COC with 'natural' estrogen discontinued and reported bleeding irregularities compared with those using the COC containing EE.…”

Section: New Oral Contraceptives With Estradiol [E2 or Estradiol Valementioning

confidence: 99%

50 years of "The Pill": celebrating a golden anniversary

Szarewski

Mansour²,

Shulman³

2010

j fam plann reprod health care

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The past 50 years have seen great advances in combined oral contraceptives (COCs) that have resulted in reduced risks of adverse events and improved cycle control. The most important changes in COCs over time include repeated lowering of the estrogen dose, development of new progestogens, and the reduction or elimination of the pill-free interval. Most IntroductionThe launch of Enovid-10 ® (G D Searle Co., Skokie, IL, USA), the first combined oral contraceptive (COC), in 1960 revolutionised family planning by giving women control over their own fertility. The social, political and economic implications were so profound that although countless oral medications have been approved both before and after this event, the contraceptive pill is the only one to be known as "The Pill". Indeed, it was Aldous Huxley who first used the term, with eerie foresight, in his essay Brave New World Revisited, published in 1958. Today, half a century later, over 100 million women worldwide use oral contraceptives. 1 Although increased contraceptive use has been accompanied by a trend towards fewer abortions, 2 unplanned pregnancies remain prevalent and their social, health and environmental consequences pose a contemporary global challenge, 3 with population control being described as the "greatest challenge facing humanity". 4 Here we review half a century of oral contraceptive use; examine how and why The Pill has evolved; describe the contraceptive needs of changing societies; and discuss current and emerging issues and developments related to birth control. morbidity and mortality. Among 210 million pregnancies each year, 38% are unplanned and 22% end in abortion. 3,6 In the USA, nearly half of the approximate 6.5 million annual pregnancies are unintended, resulting in approximately US$5 billion in direct medical costs. 7 An estimated 5 million women in 13 developing countries are hospitalised each year due to abortion-related haemorrhage, sepsis or other complications. 8 Unsafe abortions are responsible for approximately 70 000 deaths each year, accounting for an estimated 13% of maternal deaths worldwide 9 and for the orphaning of approximately 2201000 children. 10 Unsafe abortion also poses a significant economic burden and long-term psychological and health issues such as infertility and other disabilities. 10,11 Unintended pregnancies are associated with high-risk antenatal behaviours such as smoking and excessive alcohol consumption, which increase the risk of poor pregnancy outcomes as well as adverse maternal outcomes. 12,13 Unintended pregnancies also have serious environmental and political consequences, with overpopulation described as the world's worst environmental problem. 14 Population growth has placed an unprecedented demand on our planet's finite resources while simultaneously increasing the amount and types of environmental pollution. Indeed, there have been calls to implement universal family planning services as a component of policy responses to environmental degradation. 15,16 The benefi...

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“…It also contains the synthetic progestogen dienogest (DNG), a component of a COC that is more potent than levonorgestrel and has been available for more than 10 years in other countries 3 , 11 , 12. The summary of product characteristics (SPC) for Qlaira gives instructions on when it should be started (relative to the woman’s menstrual cycle, or when she stopped using a previous contraceptive method, or had a miscarriage or delivery) 11.…”

Section: What Is Qlaira?mentioning

confidence: 99%

“…by those who otherwise have regular heavy menstrual bleeding) or as a disadvantage (e.g. if it leads to anxiety about possible unwanted pregnancy) 3 , 11 , 12 , 15…”

Section: Clinical Efficacy Of Qlairamentioning

confidence: 99%

What role for ▼Qlaira in contraception?

2010

DTB

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Around 25% of women in the UK aged 16-49 years use oral contraception.1 Annually, around 5 million combined oral contraceptive (COC) items are prescribed in primary care in England alone, at a cost of over pound40 million. The effectiveness of such contraception depends on correct and consistent use of the pills and is influenced by unwanted effects that can lead to discontinuation (e.g. bleeding irregularities), and by adherence to specified procedures for when a pill is missed. Qlaira (Bayer plc) is the first licensed COC in the UK to include the oestrogen estradiol valerate (E2V, which is metabolised to oestradiol, a natural human hormone) and the progestogen dienogest (DNG). It has been marketed as "the first and only COC to deliver...the same oestrogen as produced by a woman's body". In theory, it might be less likely than other COCs to cause unwanted effects. However, it has a complex dosage regimen, and has its own missed-pill guidance which differs substantially from that for other pills.3 Here we review the effectiveness and place of Qlaira.

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Qlaira<SUP>®</SUP>: a 'natural' change of direction

Cited by 16 publications

References 12 publications

New developments in oral contraception: clinical utility of estradiol valerate/dienogest (Natazia®) for contraception and for treatment of heavy menstrual bleeding: patient considerations

New developments in oral contraception: clinical utility of estradiol valerate/dienogest (Natazia®) for contraception and for treatment of heavy menstrual bleeding: patient considerations

50 years of "The Pill": celebrating a golden anniversary

What role for ▼Qlaira in contraception?

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Qlaira<SUP>®</SUP>: a 'natural' change of direction

Cited by 16 publications

References 12 publications

New developments in oral contraception: clinical utility of estradiol valerate/dienogest (Natazia&reg;) for contraception and for treatment of heavy menstrual bleeding: patient considerations

New developments in oral contraception: clinical utility of estradiol valerate/dienogest (Natazia&reg;) for contraception and for treatment of heavy menstrual bleeding: patient considerations

50 years of "The Pill": celebrating a golden anniversary

What role for ▼Qlaira in contraception?

Contact Info

Product

Resources

About

New developments in oral contraception: clinical utility of estradiol valerate/dienogest (Natazia®) for contraception and for treatment of heavy menstrual bleeding: patient considerations

New developments in oral contraception: clinical utility of estradiol valerate/dienogest (Natazia®) for contraception and for treatment of heavy menstrual bleeding: patient considerations