Qlaira: new oral contraceptive

Bayer has launched Qlaira, the first combined oral contraceptive to use estradiol valerate as its oestrogen component.

PHARMACOLOGY

Qlaira (estradiol valerate/dienogest) is an oral contraceptive with four sequential phases comprising differing levels of the oestrogen, estradiol valerate, and the progestogen, dienogest, in a oestrogen step-down and progestogen step-up regimen.

While there have been many new progestogens developed for use in oral contraceptives, Qlaira is the first phasic contraceptive to use an oestrogen component other than ethinylestradiol. The oestrogen in Qlaira is estradiol valerate which is rapidly metabolised to estradiol, a naturally occurring oestrogen.

Dienogest is a nortestosterone derivative with anti-androgenic activity.

As with all combined oral contraceptives the contraceptive effects are due to numerous factors of which inhibition of ovulation inhibition and changes to cervical secretions and the endometrium are thought to be the most important.

CLINICAL STUDIES

In clinical trials performed with Qlaira the following Pearl Indices (pregnancies per 100 women-years) were calculated:1

  • Pearl Index (18-50 years)
    Method failure – 0.42
    (upper limit 95 per cent CI 0.77)
    User and method failure – 0.79
    (upper limit 95 per cent CI 1.23)
  • Pearl Index (18-35 years)
    Method failure – 0.51 (upper limit 95 per cent CI 0.97)
    User and method failure – 1.01
    (upper limit 95 per cent CI 1.59)

Previous efforts to use estradiol in oral contraception failed to achieve a satisfactory level of cycle control. However, clinical studies have shown estradiol valerate to produce efficient ovulation inhibition.2

Qlaira also showed encouraging results in a study that compared its four-phase regimen of estradiol valerate/dienogest to a monophasic regimen of ethinylestradiol 20 microgram and levonorgestrel 0.1mg over seven cycles. Both the intensity and duration of withdrawal bleeding was reduced with estradiol valerate/dienogest compared with ethinylestradiol/levonorgestrel. The incidence of intracyclic bleeding, the safety profile and the overall rate of treatment satisfaction were comparable for the two regimens.3

In addition a study has shown that a four-phasic regimen of estradiol valerate/dienogest has minimal effect on haemostatic parameters and may have a favourable effect on lipid profiles compared to a triphasic regimen of ethinylestradiol/levonorgestrel.4

View Qlaira drug record

REFERENCES

  1. Qlaira Summary of Product Characteristics. Available at EMC. Accessed 19 May 2009.
  2. Endrikat J, Parke S, Trummer et al. Ovulation inhibition with four variations of a four-phasic estradiol valerate/dienogest combined oral contraceptive:results of two prospective, randomized, open-label studies. Contraception 2008: 78; 218-25.
  3. Ahrendt H, Makalova D, Parke S  et al. Bleeding patterns and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized, comparative trial of estradiol valerate/dienogest and ethinylestradiol/levonorgestrel. Contraception 2009: In Press.
  4. Parke S, Nahum G, Mellinger U et.al. Metabolic effects of a new four-phasic oral contraceptive containing estradiol valerate and dienogest. Obstet Gynecol 2008: 111 (4 suppl); 12S-13S.

Further information: Bayer


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