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Tuesday, 8 September 2009 15:33 GMT
Bayer Schering officially launches new 'natural' oestrogen pill in France
PARIS, Sept 8 (APM) - Bayer Schering Pharma said on Tuesday its new 'natural' oestrogen contraceptive pill Qlaira is set to revolutionise contraception.
Qlaira has been available in pharmacies in France since Aug 31. The pill is a combination of dienogest, and estradiol valerate that the body metabolises to estradiol, identical to the 17-beta estradiol produced by a woman's ovaries. The 28 pills making up a month's supply comprise five different types of tablet, including two placebo tablets.
Dr Laurent Stoll, head of women's health at BSP said at a press conference in Paris that Qlaira is not reimbursed and pharmacies sell a 28 pill blister at between 10 and 13 euros. He described Qlaira as a "revolution".
Both Dr Brigitte Letombe of the Lille University hospital and Professor Patrice Lopes of the Nantes University hospital agreed with Stoll's description.
Qlaira has a 'natural' oestrogen but because it is actually a synthetic molecule, it is more accurate to say that it is bio-identical.
Estradiol valerate has long been used in hormone replacement therapy (HRT).
Since the 1980s there have been attempts to develop an oral contraceptive with "natural" oestrogen but the prototypes failed because it was difficult to control bleeding.
Letombe said: "These days effective contraception is no longer sufficient. Women want benefits and an absence of risk."
Qlaira uses dienogest and has a "dynamic" administration regimen; oestrogen is administered in "step-down" doses, while dienogest is administered in "step-up" doses.
The adjusted Pearl index is 0.42 in women aged from 18 to 50, while it is 0.51 in women aged 18 to 35. Lopes also stressed that Qlaira shows very good tolerability, with 80% of women continuing with this pill after 20 cycles and only 10.3% leaving the trials because of side-effects.
IMPROVING METABOLIC AND VASCULAR TOLERANCE
The aim of using oestrogen that is identical to endogenous oestrogen is to improve metabolic and vascular tolerance.
The current oral contraceptives do carry a slight risk of venous thrombosis but Lopes pointed out that with natural estradiol, it was realistic to expect a lower level of risk.
Letombe said that the Phase II studies showed modifications in the lipid profile and of coagulation factors that were in favour of Qlaira in comparison with a standard pill with levonorgestrel and ethinylestradiol.
Dienogest has a short half-life (11 hours) high bioavailability and has anti-androgenic action.
Lopes said, however, there was no question of prescribing Qlaira to women who have a risk of venous thromboembolic or cardiovascular events. He said there were not enough clinical data so far.
cd/aki/nh
[16273] 08/09/2009 15:33 GMT - GYNAECO
Qlaira has been available in pharmacies in France since Aug 31. The pill is a combination of dienogest, and estradiol valerate that the body metabolises to estradiol, identical to the 17-beta estradiol produced by a woman's ovaries. The 28 pills making up a month's supply comprise five different types of tablet, including two placebo tablets.
Dr Laurent Stoll, head of women's health at BSP said at a press conference in Paris that Qlaira is not reimbursed and pharmacies sell a 28 pill blister at between 10 and 13 euros. He described Qlaira as a "revolution".
Both Dr Brigitte Letombe of the Lille University hospital and Professor Patrice Lopes of the Nantes University hospital agreed with Stoll's description.
Qlaira has a 'natural' oestrogen but because it is actually a synthetic molecule, it is more accurate to say that it is bio-identical.
Estradiol valerate has long been used in hormone replacement therapy (HRT).
Since the 1980s there have been attempts to develop an oral contraceptive with "natural" oestrogen but the prototypes failed because it was difficult to control bleeding.
Letombe said: "These days effective contraception is no longer sufficient. Women want benefits and an absence of risk."
Qlaira uses dienogest and has a "dynamic" administration regimen; oestrogen is administered in "step-down" doses, while dienogest is administered in "step-up" doses.
The adjusted Pearl index is 0.42 in women aged from 18 to 50, while it is 0.51 in women aged 18 to 35. Lopes also stressed that Qlaira shows very good tolerability, with 80% of women continuing with this pill after 20 cycles and only 10.3% leaving the trials because of side-effects.
IMPROVING METABOLIC AND VASCULAR TOLERANCE
The aim of using oestrogen that is identical to endogenous oestrogen is to improve metabolic and vascular tolerance.
The current oral contraceptives do carry a slight risk of venous thrombosis but Lopes pointed out that with natural estradiol, it was realistic to expect a lower level of risk.
Letombe said that the Phase II studies showed modifications in the lipid profile and of coagulation factors that were in favour of Qlaira in comparison with a standard pill with levonorgestrel and ethinylestradiol.
Dienogest has a short half-life (11 hours) high bioavailability and has anti-androgenic action.
Lopes said, however, there was no question of prescribing Qlaira to women who have a risk of venous thromboembolic or cardiovascular events. He said there were not enough clinical data so far.
cd/aki/nh
[16273] 08/09/2009 15:33 GMT - GYNAECO
