A5055773399- Endometriosis Research and Treatment
- Uterine Myomas and Treatments
- Reproductive Health and Contraception
- Health Systems, Economic Evaluations, Quality of Life
- Statistical Methods in Clinical Trials
- Pregnancy-related medical research
- Gynecological conditions and treatments
- Hormonal Regulation and Hypertension
- Breast Cancer Treatment Studies
- Ovarian function and disorders
- Hormonal and reproductive studies
- Menopause: Health Impacts and Treatments
- Endometrial and Cervical Cancer Treatments
- Maternal Mental Health During Pregnancy and Postpartum
- Maternal and Perinatal Health Interventions
- Meta-analysis and systematic reviews
- Menstrual Health and Disorders
- Estrogen and related hormone effects
- Blood Pressure and Hypertension Studies
- Advanced Causal Inference Techniques
- Ethics in Clinical Research
- Pharmaceutical Economics and Policy
- Blood Coagulation and Thrombosis Mechanisms
- Reproductive System and Pregnancy
- Pharmaceutical studies and practices
Saarland University
2016-2025
Bayer (Germany)
2015-2025
Bayer (France)
2011-2021
Klinik für Frauenheilkunde
2014-2020
Universitätsklinikum des Saarlandes
2016-2020
Universitäts-Frauenklinik des Saarlandes
2016-2019
University Hospital Heidelberg
2009
Heidelberg University
2009
Bayer (United States)
2007
Statistisches Bundesamt
2007
In 2009 the Uterine Bleeding and Pain Women's Research Study (UBP-WRS) was conducted interviewing 21,479 women across 8 countries in order to gain patient-based prevalence data on uterine pain bleeding indications investigate symptoms women's treatment experiences. This article shows relevant results of study for indication fibroids providing self-reported prevalence, symptomatology management fibroids. 2,500 (USA: 4,500 women) each country (Brazil, Canada, France, Germany, Italy, South...
Dienogest is a selective progestin that has been investigated in clinical trial programme for the treatment of endometriosis. The current non-inferiority compared efficacy and safety dienogest against leuprolide acetate (LA) treating pain associated with endometriosis.Patients confirmed endometriosis were randomized to (2 mg/day, orally) or LA (3.75 mg, depot i.m. injection, every 4 weeks) 24 weeks. primary variable was absolute change pelvic from baseline end treatment, assessed by visual...
Rationale: Exacerbations are key events in the natural history of bronchiectasis, but clinical predictors and outcomes patients with frequently exacerbating disease not well described.Objectives: To establish if there is a “frequent exacerbator phenotype” bronchiectasis impact exacerbations on long-term outcomes.Methods: We studied enrolled from 10 centers Europe Israel, up to 5 years follow-up. Patients were categorized by baseline exacerbation frequency (zero, one, two, or three more per...
To investigate the efficacy and safety of dienogest as a long-term treatment in endometriosis, with follow-up after discontinuation. The study included women who had previously completed 12-week, placebo-controlled dienogest, participated an open-label extension for up to 53 weeks. Thereafter, patient subgroup was evaluated 24-week A multicenter performed Germany, Italy Ukraine. Women endometriosis were enrolled at completion (n = 168). All received (2 mg once daily, orally) changes pelvic...
To compare the country-specific value sets of EQ-5D-5L utility index and to evaluate impact on interpretation clinical study results. Six country from Canada, England, Japan, Korea, Netherlands Uruguay were obtained literature. In addition, ten crosswalk downloaded EuroQol.org website. For each 3125 possible health states difference between with highest lowest was calculated. The median 0.417 across states. When analyzing multinational studies, should be used treatment effects. Additional...
Abstract Introduction As patient-reported outcomes (PROs) are increasingly used in the evaluation of medical treatments, it is important that PROs carefully analyzed and interpreted. This may be challenging due to substantial missing values. The missingness often closely related patients’ disease status. In case, using observed information about intercurrent events (ICEs) such as progression death will improve handling PRO data. Therefore, aim this study was develop imputation models for...
Yasmin (Schering AG, Berlin, Germany), a new oral contraceptive containing 30 microg ethinylestradiol combined with 3 mg drospirenone, effectively inhibits ovulation, as demonstrated by measurement of plasma hormone levels (follicle stimulating hormone, luteinizing estradiol and progesterone), echographic evaluation follicular ripening. Like other low-dose contraceptives, the combination drospirenone markedly limits cervical function, spinnbarkeit degree crystallization, resulting in hostile...
When comparing active treatments, a non-inferiority (or one-sided equivalence) study design is often used. This requires the definition of margin, threshold value clinical relevance. In recent studies, margin 15 mm has been used for change in endometriosis-associated pelvic pain (EAPP) on visual analog scale (VAS). However, this was derived from other chronic painful conditions and its validation EAPP lacking. Data were analyzed two placebo-controlled studies treatments endometriosis,...
In four randomized, controlled, European trials, dienogest 2 mg once daily demonstrated significant efficacy for lesion reduction and in pain intensity endometriosis. We describe a pooled analysis of the safety tolerability data from these trials to confirm further characterize profile treatment endometriosis.All 332 women treated with who participated clinical were included analyses assessments, including adverse events, laboratory tests, vital signs, body weight, bleeding patterns. Safety...
With more and better clinical data being captured outside of studies greater sharing studies, external controls may become a attractive alternative to randomized trials (RCTs). Both industry regulators recognize that in situations where study cannot be performed, can provide the needed contextualization allow interpretation without control. It is also agreed will not fully replace RCTs as gold standard for formal proof efficacy drug development yardstick research. However, it remains unclear...
Abstract Background The Endometriosis Symptom Diary (ESD) and Impact Scale (EIS) are patient-reported outcome measures developed to evaluate efficacy in clinical trials practice. ESD is a daily electronic diary assessing symptom severity; the EIS weekly impact. This study explored importance of symptoms (ESD items) impacts (EIS domains), perspectives on scoring algorithms, clinically important difference (CID) thresholds inform trial score interpretation. Methods patients Germany (n = 8) US...
AbstractObjective To assess the contraceptive reliability, cycle control and tolerance of a new monophasic oral (Yasmin®) containing 30 μg ethinylestradiol 3 mg drospirenone compare it with preparation an equal dose combined 150 desogestrel (Marvelon®).Methods A multicenter, open-label, randomized study was carried out in 26 European centers. Contraceptive efficacy, (including body weight, blood pressure heart rate) were assessed over cycles, plus 3-month follow-up period.Results Of 900...
Purpose The symptoms of endometriosis are heterogeneous and overlap with those other conditions, resulting in misdiagnoses and/or delayed diagnosis treatment. Uterine Bleeding Pain Women's Research Study (UBP-WRS) collected data to elucidate differences diagnoses treatment experiences women, assess the impact on their quality life. Methods UBP-WRS interviewed women aged 15 49 eight countries using an online methodology. Quotas were applied for age, region, level education, income...
Endometriosis presents with significant pain as the most common symptom. Generic health measures can allow comparisons across diseases or populations. However, Medical Outcomes Study Short Form 36 (SF-36) has not been validated for this disease. The goal of study was to validate SF-36 (version 2) endometriosis. Using data from two clinical trials (N = 252 and 198) treatment endometriosis, a full complement psychometric analyses performed. Additional instruments included visual analog scale...
Very recently the new pathogen severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified and disease 2019 (COVID-19) declared a pandemic by World Health Organization. The has number of consequences for ongoing clinical trials in non-COVID-19 conditions. Motivated four current variety areas we illustrate challenges faced sketch out possible solutions including adaptive designs. Guidance is provided on (i) where blinded adaptations can help; (ii) how to achieve Type I error...