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Paris (ots) - At this year's 7th congress of the European Society of Gynaecology (Paris, 10-14 October 2007), the German pharmaceutical company Grunenthal GmbH presents the latest study results for its oral contraceptive Belara®. As the first of its kind the dermatological CEFIS-Study* of the University of Hamburg shows an impressive cosmetic improvement of impured skin due to the anti-androgenic properties of CMA (chlormadinone acetate) in combination with EE (ethinylestradiol) based on objective biophysical measurement methods.
The results of the clinical, prospective, open, single-centre, single-arm, phase-IV CEFIS study show the clear improvement of complexion by verifiable and quantifiable biophysical measurement methods: 44 women with an average age of 29 years who are suitable for and who wish hormonal contraception took the low-dosed, monophasic contraceptive Belara® containing 2.0 mg CMA and 0.03 ethinylestradiol (EE) (following a seven-day break) for a period of six treatment cycles.
After 12 weeks a significant positive development regarding skin impurity and pore size (p<0.0001) were measured; the clinical sum score regarding the number of papules, papulopustules, comedones as well as sebaceous glands - activity diminished from 14.0 to 9.0 (with p=<0.0001). While horny layer hydration showed a highly significant increase (p2 < 0.0001 both cheeks) after 24 weeks, the transepidermal water loss (TEWL), a marker for the barrier function of the skin, decreased highly significantly from 19.2 g/m2/h (+/- SD 4.4) to 15.5 g/m2/h (+/- 3.5) after six cycles. The data correlate with the fact that at the end of the study the majority of women (> 85%) found that the improvement in their impure skin was very good or good.
"Even though this first study was designed to be explorative, its results illustrate that the intake of a contraceptive containing the anti-androgenic acting CMA can be a central asset for the additional treatment of impure skin for women who wish and who are suitable for hormonal contraception", thus comments Prof. Martina Kerscher of Hamburg University.
About Belara® Belara® is a modern oral contraceptive containing 2 mg chlormadinone acetate and 0.03 mg ethinylestradiol. Today Belara® is available in over 30 countries worldwide. Belara is ranked Nr 2 in the German oral contraception market and Nr 2 among teenage users. www.belara.com
About Grunenthal Grunenthal is an expert in pain therapy and gynaecology and a pioneer in intelligent, user-friendly drug delivery technologies. Founded in 1946, the company employs 1,900 people in Germany and 4,800 worldwide. In 2006, Grunenthal achieved revenues of 813 million Euro. www.grunenthal.com
References Kerscher et al. (2006), "Unreine Haut": Effekte eines oralen monophasischen Kontrazeptivums: Evaluation mittels klinischem Score und biophysikalischen Messverfahren, 56. Kongress der dt. Gesellschaft für Gynäkologie und Geburtshilfe, 19.-22.Sept. 2006, Berlin, PO-E 02.11.
* CEFIS: Chlormadinone Ethinylestradiol For Impure Skin
ots Originaltext: Grünenthal GmbH
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