Affiliation: Bayer HealthCare
- Estimation of menstrual blood loss volume based on menstrual diary and laboratory dataUlrike Schumacher
Medical Affairs Support, Jenapharm GmbH und Co KG 07743, Jena, Germany
BMC Womens Health 12:24. 2012..Bleeding diaries, although widely used, provide only qualitative information on menstrual blood loss. Other methods have been developed, but still do not provide reliable quantitative data...
- Treatment of endometriosis in different ethnic populations: a meta-analysis of two clinical trialsChristoph Gerlinger
Global Biostatistics, Bayer HealthCare Pharmaceuticals, Müllerstraße 178, 13353 Berlin, Germany
BMC Womens Health 12:9. 2012..DNG was significantly superior to GnRH analogues for bone mineral density change in both trials, but significant heterogeneity between the studies may indicate ethnic differences in physiology...
- An empirically validated responder definition for the reduction of moderate to severe hot flushes in postmenopausal womenChristoph Gerlinger
Global Clinical Statistics, Bayer Pharma AG, Berlin, Germany
Menopause 19:799-803. 2012..The aim of this study was to derive an empirically validated definition of treatment responders for the reduction of moderate to severe hot flushes in postmenopausal women...
- Prevalence, symptoms and management of uterine fibroids: an international internet-based survey of 21,746 womenAnne Zimmermann
Charite Universitatsmedizin Berlin, Berlin School of Public Health, Seestraße 73, Berlin 13347, Germany
BMC Womens Health 12:6. 2012..This article shows relevant results of the study for the indication uterine fibroids providing data on self-reported prevalence, symptomatology and management of uterine fibroids...
- Considerations on what constitutes a 'qualified statistician' in regulatory guidelinesChristoph Gerlinger
Bayer Pharma AG, Global Clinical Statistics, D 13342, Berlin, Germany
Stat Med 31:1303-5. 2012..No consensus on what constitutes a 'qualified statistician' appears to have been developed so far. The International Society for Clinical Biostatistics is issuing this reflection paper in order to stimulate a discussion on the concept...
- Determining the non-inferiority margin for patient reported outcomesChristoph Gerlinger
Bayer Pharma AG Global Clinical Statistics
Pharm Stat 10:410-3. 2011..In conclusion, for patient-observed endpoints, the delta can be derived empirically. In our view, this is a better approach than that of asking the clinician for a "nice round number" for delta, such as 10, 50%, π, e, or i...
- Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trialsChristoph Gerlinger
Global Clinical Statistics, Bayer Schering Pharma AG, 13342 Berlin, Germany
Health Qual Life Outcomes 8:138. 2010..However, this value was derived from other chronic painful conditions and its validation in EAPP was lacking...
- Bleeding pattern, tolerance and patient satisfaction with a drospirenone-containing oral contraceptive evaluated in 3488 women in Europe, the Middle East and CanadaJan S Endrikat
Bayer Inc, Medical and Scientific Affairs, ON, Canada
Contraception 79:428-32. 2009..This study was conducted to assess the bleeding pattern, tolerance and patient satisfaction associated with an oral contraceptive (OC) containing 3 mg of drospirenone and 30 mcg of ethinyl estradiol under real-life conditions...
- A Canadian multicentre prospective study on the effects of an oral contraceptive containing 3 mg drospirenone and 30 microg ethinyl oestradiol on somatic and psychological symptoms related to water retention and on body weightJan Endrikat
Bayer Inc, Toronto, Ontario, Canada
Eur J Contracept Reprod Health Care 12:220-8. 2007..To evaluate the effects of an oral contraceptive containing 3 mg drospirenone (DRSP) and 30 microg ethinyl oestradiol (EE) on somatic and psychological symptoms related to water retention, and on body weight...
- Pattern recognition in menstrual bleeding diaries by statistical cluster analysisChristoph Gerlinger
Global Clinical Statistics, Bayer Schering Pharma AG, Mullerstrasse 178, 13342 Berlin, Germany
BMC Womens Health 9:21. 2009..The aim of this paper is to empirically identify a treatment-independent statistical method to describe clinically relevant bleeding patterns by using bleeding diaries of clinical studies on various sex hormone containing drugs...