Chester Clinic

 

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Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 1 Symposium
Oral contraception and women's wellbeing
Friday 12th October 2007,
11:10 a.m. to 12:40 p.m., room no. 262
7th Congress of the European Society of Gynecology - 10th to 13th October 2007, Paris, France Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 2 Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 3 Oral contraception and women's wellbeing
Friday 12th October 2007,
11:10 a.m. to 12:40 p.m., room no. 262
Dr. Clara Pélissier-Langbort, Paris Prof. Johannes Bitzer, Basel Welcome and introduction Lecture 1
Oral contraception and hyperandrogenic disturbances of skin and hair
Hyperandrogenicity - Pathophysiological backgroundAndrogenic and antiandrogenic properties of different progestogensEvidence of CMA/EE efficacy in the treatment of hyperandrogenic skin and hair disorders Lecturer: Prof. Hans Wolff, Munich (time: 11:10 - 11:30, incl. 5 min questions) Lecture 2
Cosmetic benefits of oral contraceptives – Relevance for QoL
and psychosocial health in women
The meaning of beauty – Psychosomatic and psychosocial health of adolescent and adult womenCMA/EE – Dermatologic and cosmetic benefits for all women Prof. Martina Kerscher, Hamburg (time: 11:30 - 11:50, incl. 5 min questions) Lecture 3
CMA/EE – Improvement of women's wellbeing
Lecturer: Prof. René Druckmann, Nice (time: 11:50 - 12:10, incl. 5 min questions) Lecture 4
CMA/EE – Relief of dysmenorrhoea symptoms
and mood-balancing effects
Relief of dysmenorrhoea symptomsImprovement of depressive mood disturbances Prof. Hans Peter Zahradnik, Freiburg (time: 12:10 - 12:30, incl. 5 min questions) Discussion (time: 12:30 - 12:40)
7th Congress of the European Society of Gynecology -
10th to 13th October 2007, Paris, France

Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 4 Chairwoman: Dr. Clara Pélissier-LangbortSecretary General of the ESG,President of the 7th ESG Congress,Paris, France Co-Chairman: Prof. Johannes BitzerDepartment of Gynaecological Public Health and Psychosomatics, Universitäts-Frauenklinik, Basel, Switzerland

Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 5 Prof. Hans WolffDepartment of Dermatology and Allergology of the Ludwig-Maximilians-University of Munich,Germany Prof. Martina KerscherInstitute for Cosmetics and Personal Hygiene,University of Hamburg, Germany Prof. René DruckmannA.N.E.M.O. Centre for Menopause, Nice, FranceAssociated to the private polyclinic Santa Maria-Lenval, Nice, France Prof. Hans Peter ZahradnikDepartment of Obstetrics and GynaecologyUniversitäts-Frauenklinik, Freiburg, Germany Dr. Rosa Sabatini (Poster Abstract)Department of Obstetrics and Gynaecology,General Hospital Policlinico, University of Bari,Bari, Italy

Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 6 Oral contraception and hyper androgenic disorders
of skin and hair
Hyperandrogenicity - Pathophysiological background
Androgenic and antiandrogenic properties of different progestogens
Evidence of CMA/EE efficacy in the treatment of hyperandrogenic skin and hair disorders
Prof. Hans WolffDepartment of Dermatology and Allergology of the Ludwig-Maximilians-University of Munich,Germany Hyperandrogenic diseases are based on an endocrine dysfunction characterised byexcessive androgen production or increased endorgan sensitivity towards androgensin women. The clinical manifestations are hirsutism, androgenic alopecia, acne, sebor-rhoea, menstrual bleeding disorders and infertility, accompanied by polymetabolicdysfunctions such as obesity, hypertension and diabetes type 2. Hyperandrogenic symptoms can range in severity from a subtle cosmetic impairmentto true virilisation, depending on genetic differences in the target tissue to androgens.
Androgens bind to androgen receptors within the cell, they are precursors for estrogenproduction in the ovary and they are controlled by a feedback mechanism which ismediated by cortisol-feed-back on the hypothalamic-pituitary-adrenal axis. Hyper-androgenic disorders may be due to increased number or function of androgen-secreting cells, increased peripheral metabolism, increased sensitivity of the androgenreceptor, low levels of sex hormone binding globulin (SHBG) leading to elevated levelsof free testosterone. Especially in PCOS-patients significant morbid conditions are associated withendometrial hyperplasia, insulin resistance, diabetes mellitus type 2, and probably in-creased risk of cardiovascular disease. Available treatment options are lifestyleinterventions, anti diabetic treatment and endocrine anti androgenic treatmentincluding oral contraceptives with ethinyl estradiol in combination with antiandrogenicprogestogens. CMA is a 17-OH-progesterone derivative (pregnan group) with such antiandrogenicproperties due to competitive inhibition of the androgenic receptor, inhibition of Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 7 5-α-reductase, reduction of androgenic receptor development and inhibition ofadrenal and ovarian testosterone production. CMA has a higher progestogene activitythan natural progesterone, resulting in an endometrial transformation dosage of1.5 to 2 mg/day and a ovulation inhibition dosage of 1.7 mg per day. CMA has no androgenic or clinically relevant mineral corticoid activity. On oral admini-stration CMA is rapidly and completely absorbed. After multiple administrations themean t1/2 is 36-39 h. CMA has no clinically relevant effects on haemostasis and hasbeen used for decades in France for HRT and contraception in women withcardiovascular risk factors. It has a favourable influence on the LDL/HDL ratio and noclinically relevant effect on carbohydrate metabolism, haemostasis or other relevantlaboratory parameters.
For your notes: Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 8 Cosmetic benefits of oral contraceptives – Relevance for
QoL and psychosocial health in women
The meaning of beauty – Psychosomatic and psychosocial health of adolescent and adult women
CMA/EE – Dermatologic and cosmetic benefits for all women
Prof. Martina KerscherInstitute for Cosmetics and Personal Hygiene,University of Hamburg, Germany Especially in western societies a clear and immaculate skin symbolises health, attrac-tiveness and youth. Not fulfilling this ideal may cause considerable psychosocial stressfor those affected and distinctly impair quality of life. Especially for adolescent womengreasy hair and impured skin is a common problem (Kerscher et al. 2004). Clinicallythe severity of impured skin may vary considerably, and there is no clear-cut transitionto acne vulgaris. In women of reproductive age, acne and seborrhoea can often be treated successfullyby taking combined oral contraceptives containing a potent antiandrogenicprogestogen. Chlormadinone acetate is a progestogen showing comparable antiandro-genic properties to cyproterone acetate in a dosage range suitable for contraceptiveuse (Terouanne et al. 2002). Comparing the clinical efficacy of the progesteronederivative chlormadinone acetate (2 mg CMA/0.03 mg EE (Belara®)) to the testosteronederivative levonorgestrel (0.15 mg LNG/0.03 mg EE (Mikrogynon®)), both in combinationwith 0.03 mg ethinyl estradiol, in reducing moderate papulopustular acne, 59.4% ofwomen using CMA/EE vs. 45.9% of women using LNG/EE were responders (n=199female acne patients). Complete resolution of acne was seen in 16.5% of womenreceiving CMA/EE and 4.3% receiving LNG/EE (Worret et al. 2001). In a placebocontrolled study by Cunliffe et al. 2007 (in publication) 64.1% (161/251) of women withacne responded with CMA/EE vs. 43.7% (55/126) of those taking placebo (p=0.0001).
In a self-assessment rating 70.5% of the CMA/EE users vs. 41.3% of the placebo usersreported disappearance or at least a satisfactory improvement of their acne. Due to its efficacy in acne and seborrhoea CMA/EE provides excellent cosmetic anddermatological benefits even in women, who do not suffer from pathological skin Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 9 and hair disorders. In an open monocentric, non-controlled phase IV study in 50women with impure skin, the appearance of the skin using CMA/EE dur-ing a 6-monthtreatment phase improved significantly (p<0.01) by reducing the number of comedones,papulopustules and the activity of the sebaceous glands. The size of the pores generally decreased, whereas the water content of the skinincreased and barrier function improved. More than 85% of women stated verysatisfactory improvement of the skin after six treatment cycles. This study clearly demonstrates the cosmetic benefit even for those women, who donot suffer from clinically relevant acne, but from impured, seborrhoeic skin withenlarged pores. The demonstrated effects can be important for the psychosocial well-being and quality of life, not only for young women but also for women up to 35 years. For your notes: Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 10 CMA/EE – Improvement of women's wellbeing
Prof. René DruckmannA.N.E.M.O. Centre for Menopause, Nice, FranceAssociated to the private polyclinic Santa Maria-Lenval, Nice, France Modern oral hormonal contraceptives are safe and low in side-effects. Only a fewcontraindications restrict their use. Nevertheless, compliance is sometimes less thanideal for various reasons. To prevent unwanted pregnancies and insufficient therapeuticoutcomes it is absolutely necessary to ensure acceptable compliance in contraceptiveuse. Compliance can only be guaranteed by the acceptance of a contraceptive in aninformed consent. For the doctor it is therefore essential to offer a contraceptive method, adapted to theindividual needs of the woman. The combination of 2 mg chlormadinone acetate and0.03 mg ethinyl estradiol (Belara®) is one such possibility in contraception. The excellentcompliance rate of CMA/EE above 90%, reflecting a good acceptance and tolerabilityprofile in clinical use (Schramm and Steffens 2002 and 2003), is derived from animpressive Pearl index: unadjusted: 0.44 (95% CI 0.2 – 0.8), adjusted: 0.04 (95% CI, 0.002– 0.2), a low rate of intermenstrual bleeding: about 8 per cent up to the third cycleand below 2 per cent from the twelfth cycle, a high cycle stability: in about 98% fromthe sixth cycle onwards, good weight stability: unchanged or decreased in about 84%from the twelfth cycle, a very low rate of side-effects: below 2% after twelve cycles,a very low rate of thromboembolic events: 2.07 VTE/10,000 women years, very goodcycle stability, the absence of clinically relevant metabolic effects and no disturbanceof libido and mood. However, the concomitant benefits of CMA/EE also contribute to the good compliance;these include an almost 70% improvement or complete remission of increased sebor-rhoea after twelve months, almost 90% improvement or cure of acne symptoms aftertwelve months due to the antiandrogenic properties of CMA/EE. Significant remission Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 11 of dysmenorrhoea after twelve months in 79%, after 4 cycles in 95% a significantreduction of pre-existing dysmenorrhoea and improvement of depressive mooddisturbances in more than 60% of women after switching to CMA/EE from anotherOC. Therefore CMA/EE (Belara®) is an excellent oral hormonal contraceptive providinghigh contraceptive efficacy and safety in combination with considerable additionalbenefits for health and beauty.
For your notes: Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 12 CMA/EE – Relief of dysmenorrhoea symptoms
and mood-balancing effects
Relief of dysmenorrhoea symptoms
Improvement of depressive mood disturbances
Prof. Hans Peter ZahradnikDepartment of Obstetrics and GynaecologyUniversitäts-Frauenklinik, Freiburg, Germany In clinical practice dysmenorrhoea and mood changes are important factors in diminish-ing a woman's quality of life and well-being. Both symptoms are to be taken intoconsideration, when prescribing hormonal contraceptives. The prevalence ofdysmenorrhoea, inexplicable by anatomic pathology is highest in adolescent women,with estimates ranging from 20 to 90%, depending on the psychological analyticalinstruments used (Davis et al. 2001, Bani-karim et al. 2000, Strinic et al. 2003). 10%of the 24-year-olds reported pain that interfered with daily work. Over 9% of women are absent from work once a month. 20% of all affected womenrequire medical treatment. Oral contraceptives in general can have a beneficial effecton dysmenorrhoea symptoms, but in a particular impressive manner, a reduction ofdysmenorrhoea symptoms is seen in large observational studies for chlormadinoneacetate (CMA) in combination with ethinyl estradiol (EE) (Schramm and Steffens 2002and 2003). CMA is a derivative of the naturally secreted hormone progesterone. Even women who were still suffering from dysmenorrhoea while taking other OCsexperienced a significant improvement in the number of painful menstrual periods afterswitching to CMA/EE (Schramm and Heckes 2007). As expected, the use of CMA/EE,like that of other OCs, causes a significant reduction in endometrial thickness andreduces total endometrial production of the uterine contracting prostaglandin F2α.
Since a further reduction in endometrial thickness is unlikely, CMA must be assumedto have a special pharmacological action in relation to endometrialphospholipid/arachidonic acid metabolism. Should this prove to be the case, CMAwould be of particular therapeutic relevance not only for dysmenorrhoea but also for Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 13 a variety of other therapeutic indications. Dysmenorrhoea and mood changes inwomen go hand in hand becoming subjectively intensified. A great number of womenof reproductive age suffer from sudden mood swings, irritability, nervousness,excitability and anxiety associated with a considerable decrease in quality of life.
Endogenous steroid hormones may interact with the central nervous system. Among them progesterone and its metabolite allopregnanolone have beendemonstrated to produce mood-balancing and anxiolytic effects via activation of theGABAA receptor, a major regulator of mood function in the brain. When oralcontraception is considered, it has to be taken into account that the various syntheticprogestogens used may differ in their influence on mental state. For CMA large observational studies for at least 12 cycles, including 50,000 womenhave shown that the combination of 0.03 mg EE and 2 mg CMA has prompt anddistinct mood balancing effects (Schramm and Steffens 2002 and 2003, Schrammand Heckes 2007). Based on a similar molecular structure initial research suggeststhat CMA has an allopregnanolone-like activity upon the GABAA receptor, a majorregulator of mood in the brain, having the ability to stabilise mood and reducedepressive mood swings. For your notes: Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 14 Non contraceptive benefits of two combined oral contra-
ceptives with antiandrogenic properties among adolescents
(Rosa Sabatini, Giuseppe Loverro, Loredana Digiacomantonio)
Dr. Rosa Sabatini Department of Obstetrics and Gynaecology,General Hospital Policlinico, University of Bari,Bari, Italy Objective: many adolescent girls are sexually active at earlier age than in the past,
before they are cognitively able to develop a responsible sexual behaviour. In spite of
the evident need of effective contraception, noncompliance is still an issue among
teenagers. Moreover, during the post-menarche years several kinds of menstrual
irregularity and dysmenorrhoea may occur. Yet, androgen-related skin and hair disorders,
arising from hormonal imbalance, are common problems in young women. These
conditions can lead to relevant emotional and psychological disorders affecting a
teen's selfimage. The aim of our study was to assess the non-contraceptive benefits
of two combined oral contraceptives (COCs) containing different antiandrogenic
progestogens.
Methods: in this prospective, observational study the non-contraceptives effects of
2 mg chlormadinone acetate (CMA), derived from progesterone and 3 mg drospirenone
(DRSP), derived from spironolactone, both combined with 30 µg ethinyl estradiol (EE)
were compared. Condom use was required in each group for protection against STDs.
Within a treatment period of six months, 156 sexually active adolescents, requiring
contraception were evaluated with regards to intermenstrual bleeding, dysmenorrhoea,
hair and skin disorders as well as to sexual interest, intercourse frequency and sexual
satisfaction.
Results: body weight and blood pressure did not change in either group. Although,
at cycle 3, irregular bleeding and dysmenorrhoea decreased significantly in both
groups, the significant reduction continued only in the CMA/EE group until the end
of the study. A reduction in skin and hair disorders, such as acne, greasy hair and hair
growth excess, was also seen in both groups, but there was a significant higher benefit
Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 15 in the CMA/EE group compared to the DRSP/EE at the end of the study-period. Similarly,the adolescent girls who were allocated to CMA/EE use reported the best results asregards sexual interest and sexual satisfaction. In the DRSP group there were 16 mildadverse effects versus 9 in the CMA group. Conclusion: both contraceptives used offered safety and effectiveness; even though
the best results were obtained with the formulation containing CMA/EE for all
considered parameters. The resulting adherence of CMA/EE to teenager expectations
led to the elusive goal of adolescent pill continuation.
For your notes: Abstr_Bookl_Symp_SEG_Paris:Abstract_Booklet_Symp_ESC 17.09.2007 11:06 Uhr Seite 16 BELARA® - prescription-only. Composition: 1) active ingredients: one pack of BELARA contains 21 film-coated tablets each of 0.03 mg ethinyl estradiol and 2 mg
chlormadinone acetate. 2) Other ingredients: lactose monohydrate, macrogol 6000, magnesium stearate, maize starch, hypromellose, povidone K 30, propylene gly-
col, talc, titanium dioxide (E 171); red iron oxide (E 172). Indications: hormonal contraception. Contraindications: pregnancy; lactation only after careful consid-
eration of the benefit/risk ratio; acute and chronic progressive liver diseases; Dubin-Johnson syndrome; Rotor syndrome; disorders of biliary secretion; cholestasis,
history of idiopathic jaundice and severe pruritus during pregnancy; viral hepatitis until liver function values become normal; previous or existing liver tumours; pre-
vious or existing thrombo-embolic disorders and conditions that increase susceptibility to these disorders; arterial hypertension requiring therapeutic intervention;
severe diabetes (mellitus) with associated vascular abnormalities; sickle-cell anaemia; severe disorders of lipid metabolism; diagnosed or suspected uterine or mam-
mary hormone-dependent tumours (also after treatment); endometrial hyperplasia; history of gestational herpes; otosclerosis with deterioration in previous preg-
nancies; severe obesity; migraine accompanied by sensory, perceptual and/or motorial disorders; undiagnosed genital bleeding, hypersensitivity to one of the ingre-
dients of BELARA. Reasons for immediate discontinuation: pregnancy; thrombophlebitis or thrombo-embolic manifestations; scheduled surgery (six weeks before-
hand); prolonged immobilisation (e.g. after accidents); first occurrence of migraine-like or increased frequency of unusually severe headache; acute sensory deficits
(visual, auditory disorders etc.), motorial disorders; severe upper abdominal complaints; hepatomegaly or signs of intraabdominal bleeding; pronounced rise in blood
pressure; jaundice; hepatitis; generalised pruritus; cholestasis; abnormal liver function tests; increase in epileptic seizures; first onset or recurrence of porphyria, acute
decompensation of diabetes mellitus. Conditions requiring special medical supervision: cardiac and renal diseases; migraine; epilepsy; asthma; history of phlebitis;
marked tendency to varicose veins; multiple sclerosis; Sydenham's chorea; tetany; diabetes mellitus and a ten-dency to this disorder; previous liver diseases; lipid
metabolism disorders; obesity; hypertension; endometriosis; mastopathy; otosclerosis; myomatous uterus. Adverse reactions: intracyclic bleeding; amenorrhoea;
headache, also migraine-like; breast tension; nausea, emesis; gastric symptoms; weight variations; depression; changes in libido; certain vaginal infections such as
candidiasis; reduced tolerance to contact lenses; chloasma; skin rash; erythema nodosum; upper abdominal complaints; possibly, abnormal laboratory tests; effect
on mammary tissue (see Summary of Product Characteristics); increased risk of venous and arterial thrombo-embolic diseases, this risk can be further increased by
additional factors (smoking, hypertension, blood coagulation or lipid metabolism disorders, obesity, varicose veins, history of phlebitis and thrombosis). Warnings:
factors promoting thrombo-embolic events (e.g. varicose veins, history of phlebitis and thrombosis and cardiac diseases, obesity, blood coagulation disorders) are to
be carefully identified. Smokers taking hormonal contraceptives have an increased risk of developing sometimes serious complications of vascular changes. The risk
increases with age and rising cigarette consumption. Women over 30 years of age should therefore refrain from smoking if they are taking hormonal contracep-
tives since there is an increased risk of developing sometimes serious complications of vascular changes. The occurrence of thrombo-embolic diseases among rela-
tives at an early age may indicate the presence of disorders of the coagulation system; in these cases the coagulation status should be determined. Women over 40
years of age require special supervision. Interactions with other drugs: contraceptive effectiveness may be impaired by the simultaneous use of other drugs and
substances such as barbiturates, griseofulvin, phenylbutazone, anti-epileptics, activated charcoal, rifampicin and other antibiotics. Effects on some laboratory tests.
Insulin or oral antidiabetic requirements may be changed. The elimination of theophylline or caffeine is reduced, which increases and prolongs the action of these
substances. Spotting has been reported in women taking concomitantly preparations containing St-John's-Wort. Dosage: 1 tablet daily. For detailed information
see Summary of Product Characteristics. Grünenthal GmbH, 52099 Aachen, Germany, www.grunenthal.com. Date of information: April 2005
Grünenthal GmbH - 52099 Aachen, Germany - www.grunenthal.com

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