The 'missed pill window' for Cerazette�, the estrogen-free contraceptive
pill, has been extended from 3 to 12 hours, following an agreement
reached by MRFG, the responsible European regulatory body and
Organon.(1)
This means that for the first time women can choose an oral contraceptive that is free of estrogen and its associated side effects, but with comparable reliability and margin of error as the combined pill.(2) Cerazette is the first and only estrogen-free pill that offers consistent ovulation inhibition.
Current prescribing information for "progestogen-only" pills rules that women should take their pill within a three-hour window each day, leaving little room for error. This reflects the fact that such products do not consistently prevent ovulation. Now, based on evidence of Cerazette's consistent inhibition of ovulation, its window will be extended to 12 hours. This will further widen the appeal of this estrogen-free pill.(3)
"A significant number of women - who cannot or do not want to take estrogen - stand to benefit from an oral contraceptive that does not contain estrogen. However, the appeal of traditional progestogen-only pills has always been limited by their lower reliability and more stringent pill-taking regimen compared to the combined pill. Cerazette has overturned that," said Dr Ulrich Karck, director of Stuttgart's Women's Hospital in Germany. "Cerazette has already proved tremendously popular since its introduction in Germany. The extension of its missed pill window will no doubt increase its appeal to an even greater extent."(4)
New study findings confirm prevention of ovulation
The new evidence was presented today at the 8th Congress of the European Society of Contraception. Dr Tjeerd Korver from the clinical development group of Organon presented study results showing that Cerazette consistently inhibits ovulation even when tablets are taken 12 hours late. More than 100 women took part in the study.
"The study shows that Cerazette inhibits ovulation to the extent known from the conventional combined pill," says Dr Korver. "It means women can take an estrogen-free pill just as conveniently as a combined pill and with the same confidence."
Convenience and reliability without estrogen
Estrogen, although traditionally important for preventing ovulation in the pill, is also associated with several unwelcome side effects. Headache, nausea and breast tenderness have long been associated with the estrogen content of the pill. And there are many women who cannot - or choose not to - take estrogens.
However, Cerazette's benefits do not just lie in its estrogen-free composition. With its new wider window of confidence for missed pills, Cerazette's margin for user error will be extended.
Cerazette may initially cause irregular bleeding. Some women may also have amenorrhea. However, after a few months most women will have less frequent bleeding episodes.
MRFG's approval underlines Cerazette's consistent effect on ovulation, and will increase user confidence in this estrogen-free product. This, alongside Cerazette's continuous 28-day regimen, results in an easy-to-take pill that is free of estrogen-related side effects but without any compromise of high contraceptive efficacy.(5)
About Organon
Organon - headquartered in Roseland, NJ, USA - creates and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to become or remain one of the leading pharmaceutical companies in each of its core therapeutic fields: reproductive medicine, psychiatry and anesthesia.
Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel.
1. The change to the official European prescribing information for Cerazette was agreed by the Mutual Recognition Facilitation Group (MRFG) on 27th May 2004. The MRFG was established by the Member states in March 1995 and held its first meeting in June of that year. Next step is to implement the new prescribing information by national regulatory authorities before being applicable in individual countries.
2. Traditional contraceptive pills without estrogen are known as "progestogen-only" pills (POPs), or "mini pills". The progestogen causes mucus in the cervix to thicken, which thereby prevents the penetration of sperm into the uterus and the tubes. This is a primary mode of action for conventional POP's. This effect on cervical mucus has been found to last no more than 27 hours - hence the short margin for error (3 hours) traditionally applied to POPs. However, Cerazette has a different mechanism of action from conventional POPs. Because Cerazette works by consistently preventing ovulation (as well thickening cervical mucus), studies have shown that its contraceptive efficacy is maintained for up to 36 hours after taking a tablet - hence the extension of the missed pill window from 3 to 12 hours. This is similar to that applied to combined pills (which contain both estrogen and progestogen).
3. Estrogen, although traditionally important for preventing ovulation in the pill, is also associated with several unwelcome side effects. Headache, nausea and breast tenderness have long been associated with the estrogen content of the pill. And there are many women who cannot - or choose not to - take estrogens.
4. Karck U. XVII World Congress of Gynecology and Obstetrics, Santiago,Chile, 2003.
5. Each tablet of Cerazette contains 75 micrograms of the progestogen hormone desogestrel. Tablets are taken each day for a cycle of 28 days. A recent study to assess the efficacy of Cerazette found pregnancy rates were much lower than with a conventional POP (a Cerazette Pearl Index of 0.4 versus a POP Pearl Index of 1.6). (Rice CF, Killick SR, Dieben T, Coelingh Bennink H. A comparison of the inhibition of ovulation achieved by desogestrel 75 mcg and levonorgestrel 30 mcg daily. Hum Reprod 1999; 14: 982-5).
The pregnancy rates found with Cerazette were in the range associated with traditional combined pills. The study reported by Dr Korver at the ESC congress showed that ovulation was prevented in 99% of cases, even when tablets were taken 12 hours late. Thus, accidental delays in tablet taking of up to 12 hours do not jeopardize the ovulation inhibition and contraceptive efficacy of Cerazette.
N.V. Organon (Communications)
Visiting address:
Molenstraat 110
5342 CC Oss
The Netherlands
Mailing address:
P.O. Box 20
5340 BH Oss
The Netherlands
Phone
+31.412.66.54.40
Fax:
+31.412.66.25.68
Email address:
monique.mols@organon.com
This means that for the first time women can choose an oral contraceptive that is free of estrogen and its associated side effects, but with comparable reliability and margin of error as the combined pill.(2) Cerazette is the first and only estrogen-free pill that offers consistent ovulation inhibition.
Current prescribing information for "progestogen-only" pills rules that women should take their pill within a three-hour window each day, leaving little room for error. This reflects the fact that such products do not consistently prevent ovulation. Now, based on evidence of Cerazette's consistent inhibition of ovulation, its window will be extended to 12 hours. This will further widen the appeal of this estrogen-free pill.(3)
"A significant number of women - who cannot or do not want to take estrogen - stand to benefit from an oral contraceptive that does not contain estrogen. However, the appeal of traditional progestogen-only pills has always been limited by their lower reliability and more stringent pill-taking regimen compared to the combined pill. Cerazette has overturned that," said Dr Ulrich Karck, director of Stuttgart's Women's Hospital in Germany. "Cerazette has already proved tremendously popular since its introduction in Germany. The extension of its missed pill window will no doubt increase its appeal to an even greater extent."(4)
New study findings confirm prevention of ovulation
The new evidence was presented today at the 8th Congress of the European Society of Contraception. Dr Tjeerd Korver from the clinical development group of Organon presented study results showing that Cerazette consistently inhibits ovulation even when tablets are taken 12 hours late. More than 100 women took part in the study.
"The study shows that Cerazette inhibits ovulation to the extent known from the conventional combined pill," says Dr Korver. "It means women can take an estrogen-free pill just as conveniently as a combined pill and with the same confidence."
Convenience and reliability without estrogen
Estrogen, although traditionally important for preventing ovulation in the pill, is also associated with several unwelcome side effects. Headache, nausea and breast tenderness have long been associated with the estrogen content of the pill. And there are many women who cannot - or choose not to - take estrogens.
However, Cerazette's benefits do not just lie in its estrogen-free composition. With its new wider window of confidence for missed pills, Cerazette's margin for user error will be extended.
Cerazette may initially cause irregular bleeding. Some women may also have amenorrhea. However, after a few months most women will have less frequent bleeding episodes.
MRFG's approval underlines Cerazette's consistent effect on ovulation, and will increase user confidence in this estrogen-free product. This, alongside Cerazette's continuous 28-day regimen, results in an easy-to-take pill that is free of estrogen-related side effects but without any compromise of high contraceptive efficacy.(5)
About Organon
Organon - headquartered in Roseland, NJ, USA - creates and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to become or remain one of the leading pharmaceutical companies in each of its core therapeutic fields: reproductive medicine, psychiatry and anesthesia.
Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel.
1. The change to the official European prescribing information for Cerazette was agreed by the Mutual Recognition Facilitation Group (MRFG) on 27th May 2004. The MRFG was established by the Member states in March 1995 and held its first meeting in June of that year. Next step is to implement the new prescribing information by national regulatory authorities before being applicable in individual countries.
2. Traditional contraceptive pills without estrogen are known as "progestogen-only" pills (POPs), or "mini pills". The progestogen causes mucus in the cervix to thicken, which thereby prevents the penetration of sperm into the uterus and the tubes. This is a primary mode of action for conventional POP's. This effect on cervical mucus has been found to last no more than 27 hours - hence the short margin for error (3 hours) traditionally applied to POPs. However, Cerazette has a different mechanism of action from conventional POPs. Because Cerazette works by consistently preventing ovulation (as well thickening cervical mucus), studies have shown that its contraceptive efficacy is maintained for up to 36 hours after taking a tablet - hence the extension of the missed pill window from 3 to 12 hours. This is similar to that applied to combined pills (which contain both estrogen and progestogen).
3. Estrogen, although traditionally important for preventing ovulation in the pill, is also associated with several unwelcome side effects. Headache, nausea and breast tenderness have long been associated with the estrogen content of the pill. And there are many women who cannot - or choose not to - take estrogens.
4. Karck U. XVII World Congress of Gynecology and Obstetrics, Santiago,Chile, 2003.
5. Each tablet of Cerazette contains 75 micrograms of the progestogen hormone desogestrel. Tablets are taken each day for a cycle of 28 days. A recent study to assess the efficacy of Cerazette found pregnancy rates were much lower than with a conventional POP (a Cerazette Pearl Index of 0.4 versus a POP Pearl Index of 1.6). (Rice CF, Killick SR, Dieben T, Coelingh Bennink H. A comparison of the inhibition of ovulation achieved by desogestrel 75 mcg and levonorgestrel 30 mcg daily. Hum Reprod 1999; 14: 982-5).
The pregnancy rates found with Cerazette were in the range associated with traditional combined pills. The study reported by Dr Korver at the ESC congress showed that ovulation was prevented in 99% of cases, even when tablets were taken 12 hours late. Thus, accidental delays in tablet taking of up to 12 hours do not jeopardize the ovulation inhibition and contraceptive efficacy of Cerazette.
N.V. Organon (Communications)
Visiting address:
Molenstraat 110
5342 CC Oss
The Netherlands
Mailing address:
P.O. Box 20
5340 BH Oss
The Netherlands
Phone
+31.412.66.54.40
Fax:
+31.412.66.25.68
Email address:
monique.mols@organon.com
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