Affiliation: Bayer HealthCare
- Different Pearl Indices in studies of hormonal contraceptives in the United States: impact of study populationChristoph Gerlinger
Bayer HealthCare Pharmaceuticals, 13353 Berlin, Germany Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, 66421 Homburg Saar, Germany Electronic address
Contraception 90:142-6. 2014..To examine the impact of subject characteristics on efficacy as measured by the Pearl Index (PI) in clinical trials and to make study populations similar by matching...
- 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...
- 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...
- 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...
- Population pharmacokinetic/pharmacodynamic evaluation of low-dose drospirenone with 17β-estradiol in postmenopausal women with moderate to severe vasomotor symptomsGabriele Sutter
From 1Bayer Pharma AG, Berlin, Germany 2Gynecology, Obstetrics, and Reproductive Medicine, University Medical School of Saarland, Homburg Saar, Germany and 3Clinical Research Center, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA
Menopause 21:236-42. 2014....
- 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...
- 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 randomized, double-blind, placebo-controlled study of the lowest effective dose of drospirenone with 17β-estradiol for moderate to severe vasomotor symptoms in postmenopausal womenDavid F Archer
From the 1Clinical Research Center, Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA 2Bayer Pharma AG, Berlin, Germany and 3Gynecology, Obstetrics, and Reproductive Medicine, University Medical School of Saarland, Homburg Saar, Germany
Menopause 21:227-35. 2014..25 mg/0.5 mg and 0.5 mg/0.5 mg, respectively) versus 17β-estradiol (0.3 mg) or placebo in postmenopausal women with moderate to severe vasomotor symptoms...
- A historical cycle control comparison of two drospirenone-containing combined oral contraceptives: ethinylestradiol 30 μg/drospirenone 3 mg administered in a 21/7 regimen versus ethinylestradiol 20 μg/drospirenone 3 mg administered in a 24/4 regimenJoachim Marr
Global Clinical Development, Women s Healthcare, Bayer HealthCare Pharmaceuticals, Berlin, Germany
Eur J Obstet Gynecol Reprod Biol 162:91-5. 2012....
- 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...