First and only estradiol-based oral contraceptive for the UK

Qlaira^®▼ (estradiol valerate and dienogest), establishes a new class of oral contraceptive by delivering estradiol, the same estrogen produced naturally by the female body, for the first time.

19 May, 2009 Newbury, Berkshire – UK healthcare professionals can now prescribe the first combined oral contraceptive that delivers estradiol, the same oestrogen as is produced naturally by the female body.  

The new contraceptive pill Qlaira, which is both effective and generally well tolerated, is associated with high patient satisfaction and offers women a new choice of combined oral contraception.^1,2

Since the launch of ‘The Pill’ nearly 50 years ago the oestrogen component of oral contraception has traditionally been ethinylestradiol (EE).³ Previous attempts to replace EE have failed to achieve a satisfactory level of bleeding control.⁴ Qlaira combines estradiol valerate with the progestogen dienogest in a new regimen which provides stable levels of estradiol throughout the cycle, ensuring good cycle control⁵ and effectively inhibiting ovulation.⁶

Dr Martyn Walling, GP and Family Planning Instructing Doctor, Lincolnshire, remarked; "The challenge for healthcare professionals is to find a combined oral contraceptive that suits an individual woman’s needs.  It is not enough to just offer efficacy, reliability and cycle control, this is a given. What we need is to have options that give women more individual benefits.  Today’s announcement means we have a new and different option at our fingertips to allow us to tailor a woman’s contraception to her lifestyle.”

Qlaira has been shown to be associated with high patient satisfaction, with nearly 80% of women being satisfied.^1,2 Further, in one study when asked, 90% of women (N=1322) reported maintained or improved emotional and physical well-being.^1,7

Dr Diana Mansour, Head of Contraception and Sexual Health Specialist in Newcastle-Upon-Tyne added, “Women are increasingly looking for more natural options for their health needs, and contraception is no different.  Qlaira may help them to address some of these concerns as it offers the confidence of reliable contraception and the reassurance of using a contraceptive delivering oestrogen, which is identical to that which occurs naturally in their body.”

The license was based on pivotal phase III trials involving 2,266 women.  Qlaira was shown to be over 99% effective in preventing unplanned pregnancy when taken as directed, which is in the same range as other oral contraceptives.^1,2 Qlaira is associated with an adjusted Pearl Index of 0.42⁸ and is also associated with significantly fewer bleeding/spotting days and a shorter, lighter withdrawal bleed, and has comparable intracyclic bleeding compared with another combined oral contraceptive containing 20 µg ethinylestradiol/100 µg levonorgestrel.^2,7

About Qlaira

Qlaira contains estradiol valerate (E2V) which is metabolised by the body to 17β-estradiol (E2)⁵ which is the same hormone as that naturally occurring in the body.   It also contains the progestogen dienogest which complements estradiol and is proven in combination with estradiol valerate to provide reliable contraception and good cycle control.^1,2  Dienogest works similarly to the physiological hormone progesterone.^9,10,11

The dosing regimen involves an oestrogen step-down and a progestogen step-up sequence; one pill is taken daily for 28 days, with the first 26 pills delivering hormones and the last two, placebo.² 

  Pearl Index (PI) is an indicator of efficacy for contraceptive methods. The PI is defined as the number of pregnancies per 100 women-years of exposure. The lower the PI value, the higher the efficacy of the contraceptive method.

·         Qlaira^® (estradiol valerate/dienogest) received UK Marketing Authorisation for the prevention of pregnancy in December 2008.

·         From today Qlaira is in stock and available for prescription in the UK

References

1. Parke S et al. Poster presented at ACOG 56th Annual Meeting ACOG, New Orleans, USA. May 3-7 2008.

2. Parke S et al. Poster presented at ESC Biannual Meeting, Prague, Czech Republic. April 30- May 3 2008.

3. Task Force on Oral Contraceptives. Contraception 1980; 21(5):445-459.

4. Kivinen S & Saure A. Eu J Contraception Reprod Health Care 1996;1:183 [abstract].  

5. Lu M et al. Poster presented at ACOG 55th Annual Meeting, San Diego, USA.May 7-9 2007.

6. Endrikat J et al. Poster presented at ACOG 55th Annual Meeting, San Diego, USA. May 7-9 2007.

7. Qlaira, data on file, 2009.

8. Qlaira SmPC, December 2008.

9. Teichmann A. Climacteric 2003;6(suppl 2):17-23.

10.Oettel M et al. Drugs of Today 1995;31(7):517-536.

11. Sitruk-Ware R. Drugs & Aging 2004;21(13):865-883.

(23/5/09)