scholarly journals Efficacy and cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime. Cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime.

2020 ◽  
Author(s):  
Santiago Palacios ◽  
Enrico Colli ◽  
Pedro Antonio Regidor
Keyword(s):  
Clinical Trials ◽  
Risk Factor ◽  
Single Case ◽  
Cardiovascular Safety ◽  
High Efficacy ◽  
Cardiovascular Risks ◽  
Contraceptive Pill ◽  
Venous Thromboembolic Events ◽  
The Usa ◽  
Pearl Index

Abstract Background: A new estrogen-free contraceptive has been approved by both the FDA and more than 15 European authorities. It is composed of drospirenone at a dosage of 4 mg in a regimen 24/4. The molecule is known to have anti-gonadotropic, anti-mineralocorticoid, anti-estrogenic, and antiandrogenic properties.Methods: The purpose of these clinical trials with a new estrogen-free contraceptive was to introduce a method with high efficacy and showing a profile with low cardiovascular risks.Study design: Three European and American multicenter clinical trials have been conducted in more than 2.500 patients and more than 25.000 cycles, not only demonstrating an excellent efficacy (Pearl Index of 0.73) but also investigating possible cardiovascular risks. In the USA study, 422 participants (41,9 %) had a risk factor for VTE, while in the European studies, 261 patients (16,6 %) had at least one VTE risk factor. Amount of arterial and venous thromboembolic events, hemostasiological data, blood pressure development, and ECG data were evaluated. Results: No single case of VTE was documented, no changes in hemastosiological parameters were observed, a small decrease in RR in patients with pretreatment values between 130 and 140 and7or 85 to 90 mm HG and no influence on ECG parameters were observed.Conclusions: The introduction of a new estrogen-free contraceptive with 4 mg of non-micronized drospirenone in a 24/4-day regimen expands contraception options for women as not only a high efficacy could be demonstrated during clinical trials but also a very high cardiovascular safety profile was observed even in women with cardiovascular risk factors.EudraCT registration numbers: 2010-021787-15 & 2011-002396-42. Clincaltrials.gov: NCT02269241

scholarly journals Efficacy and cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime. Cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime.

2020 ◽  
Author(s):  
Santiago Palacios ◽  
Enrico Colli ◽  
PEDRO ANTONIO REGIDOR
Keyword(s):  
Clinical Trials ◽  
Risk Factor ◽  
Single Case ◽  
Cardiovascular Safety ◽  
High Efficacy ◽  
Cardiovascular Risks ◽  
Contraceptive Pill ◽  
Venous Thromboembolic Events ◽  
The Usa ◽  
Pearl Index

Abstract Background: A new estrogen-free contraceptive has been approved by both the FDA and more than 15 European authorities. It is composed of drospirenone (DRSP) at a dosage of 4 mg in a regimen 24/4. The molecule is known to have anti-gonadotropic, anti-mineralocorticoid, anti-estrogenic, and antiandrogenic properties. The purpose of these clinical trials with a new estrogen-free contraceptive was to introduce a contraceptive method with high efficacy and showing a profile with low cardiovascular risks.Methods: Three European and American multicenter clinical trials have been conducted in more than 2,500 patients and more than 25,000 cycles, not only demonstrating an excellent efficacy (Pearl Index of 0.73) but also investigating possible cardiovascular risks. In the USA study, 422 participants (41.9 %) had a risk factor for VTE, while in the European studies, 261 patients (16.6 %) had at least one VTE risk factor. Amount of arterial and venous thromboembolic events, hemostasiological data, blood pressure development, and ECG data were evaluated. Results: No single case of VTE was documented, no changes in hemastosiological parameters were observed, a small decrease in RR in patients with pretreatment values between 130 and 140 and/or 85 to 90 mm HG and no influence on ECG parameters were observed.Conclusions: The introduction of a new estrogen-free contraceptive with 4 mg of non-micronized drospirenone in a 24/4-day regimen expands contraception options for women as not only a high efficacy could be demonstrated during clinical trials but also a very high cardiovascular safety profile was observed even in women with cardiovascular risk factors.EudraCT registration numbers: 2010-021787-15 & 2011-002396-42. Clincaltrials.gov: NCT02269241

scholarly journals Efficacy and cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime.

2020 ◽  
Author(s):  
Santiago Palacios ◽  
Enrico Colli ◽  
PEDRO ANTONIO REGIDOR
Keyword(s):  
Clinical Trials ◽  
Risk Factor ◽  
Single Case ◽  
Cardiovascular Safety ◽  
High Efficacy ◽  
Cardiovascular Risks ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
The Usa ◽  
Pearl Index

Abstract Background: A new estrogen-free contraceptive has been approved by both the FDA and more than 15 European authorities. It is composed of drospirenone (DRSP) at a dosage of 4 mg in a regimen 24/4. The molecule is known to have anti-gonadotropic, anti-mineralocorticoid, anti-estrogenic, and antiandrogenic properties. The purpose of these clinical trials with a new estrogen-free contraceptive was to introduce a contraceptive method with high efficacy and showing a profile with low cardiovascular risks.Methods: Three European and American multicenter clinical trials have been conducted in more than 2,500 patients and more than 25,000 cycles, not only demonstrating an excellent efficacy (Pearl Index of 0.73) but also investigating possible cardiovascular risks. In the USA study, 422 participants (41.9 %) had a risk factor for VTE, while in the European studies, 261 patients (16.6 %) had at least one VTE risk factor. Amount of arterial and venous thromboembolic events, hemostasiological data, blood pressure development, and ECG data were evaluated. Results: No single case of VTE was documented, no changes in hemastosiological parameters were observed, a small decrease in RR in patients with pretreatment values between 130 and 140 and/or 85 to 90 mm HG and no influence on ECG parameters were observed.Conclusions: The introduction of a new estrogen-free contraceptive with 4 mg of non-micronized drospirenone in a 24/4-day regimen expands contraception options for women as not only a high efficacy could be demonstrated during clinical trials but also a very high cardiovascular safety profile was observed even in women with cardiovascular risk factors.EudraCT registration numbers: 2010-021787-15 & 2011-002396-42. Clincaltrials.gov: NCT02269241

scholarly journals Cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime.

2020 ◽  
Author(s):  
Santiago Palacios ◽  
Enrico Colli ◽  
PEDRO ANTONIO REGIDOR
Keyword(s):  
Clinical Trials ◽  
Risk Factor ◽  
Single Case ◽  
Cardiovascular Safety ◽  
High Efficacy ◽  
Cardiovascular Risks ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
The Usa ◽  
Pearl Index

Abstract Background: A new estrogen-free contraceptive has been approved by both the FDA and more than 15 European authorities. It is composed of drospirenone at a dosage of 4 mg in a regimen 24/4. The molecule is known to have anti-gonadotropic, anti-mineralocorticoid, anti-estrogenic, and antiandrogenic properties.Methods: The purpose of these clinical trials with a new estrogen-free contraceptive was to introduce a method with high efficacy and reducing cardiovascular risks.Study design: Three European and American multicenter clinical trials have been conducted in more than 2.500 patients and more than 25.000 cycles, not only demonstrating an excellent efficacy (Pearl Index of 0.73) but also investigating possible cardiovascular risks. In the USA study, 422 participants (41,9 %) had a risk factor for VTE, while in the European studies, 261 patients (16,6 %) had at least one VTE risk factor. Amount of arterial and venous thromboembolic events, hemostasiological data, blood pressure development, and ECG data were evaluated. Results: No single case of VTE was documented, no changes in hemastosiological parameters were observed, a small decrease in RR in patients with pretreatment values between 130 and 140 and7or 85 to 90 mm HG and no influence on ECG parameters were observed.Conclusions: The introduction of a new estrogen-free contraceptive with 4 mg of non-micronized drospirenone in a 24/4-day regimen expands contraception options for women as not only a high efficacy could be demonstrated during clinical trials but also a very high cardiovascular safety profile was observed even in women with cardiovascular risk factors.EudraCT registration numbers: 2010-021787-15 & 2011-002396-42. Clincaltrials.gov: NCT02269241

scholarly journals Efficacy and cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Santiago Palacios ◽  
Enrico Colli ◽  
Pedro-Antonio Regidor
Keyword(s):  
Clinical Trials ◽  
Risk Factor ◽  
Single Case ◽  
Cardiovascular Safety ◽  
High Efficacy ◽  
Cardiovascular Risks ◽  
Search Query ◽  
Link Type ◽  
Venous Thromboembolic Events ◽  
The Usa

Abstract Background A new estrogen-free contraceptive has been approved by both the FDA and more than 15 European authorities. It is composed of drospirenone (DRSP) at a dosage of 4 mg in a regimen 24/4. The molecule is known to have anti-gonadotropic, anti-mineralocorticoid, anti-estrogenic, and antiandrogenic properties. The purpose of these clinical trials with a new estrogen-free contraceptive was to introduce a contraceptive method with high efficacy and showing a profile with low cardiovascular risks. Methods Three European and American multicenter clinical trials have been conducted in more than 2500 patients and more than 25,000 cycles, not only demonstrating an excellent efficacy (Pearl Index of 0.73) but also investigating possible cardiovascular risks. In the USA study, 422 participants (41.9%) had a risk factor for VTE, while in the European studies, 261 patients (16.6%) had at least one VTE risk factor. Amount of arterial and venous thromboembolic events, hemostasiological data, blood pressure development, and ECG data were evaluated. Results No single case of VTE was documented, no changes in hemastosiological parameters were observed, a small decrease in RR in patients with pretreatment values between 130 and 140 and/or 85 to 90 mm HG and no influence on ECG parameters were observed. Conclusions The introduction of a new estrogen-free contraceptive with 4 mg of non-micronized drospirenone in a 24/4-day regimen expands contraception options for women as not only a high efficacy could be demonstrated during clinical trials but also a very high cardiovascular safety profile was observed even in women with cardiovascular risk factors. Trial registration EudraCT registration numbers: 2010–021787-15 & 2011–002396-42. Clincaltrials.gov: NCT02269241.

ACE-2-Receptors of the Epidermis, Dermal Vascular Walls and Sebaceous Gland Cells: The Way of COVID-19 Entry into the Body?

2020 ◽  
Author(s):  
Stefan Bittmann
Keyword(s):  
Clinical Trials ◽  
Viral Infection ◽  
Sebaceous Gland ◽  
The Body ◽  
Viral Agent ◽  
Therapy Options ◽  
Vascular Walls ◽  
Fish Market ◽  
The World ◽  
The Usa

Since the outbreak near a fish market in Wuhan, China, in December 2019, researchers have been searching for an effective therapy to control the spreading of the new coronavirus SARS-CoV-2 and inhibit COVID-19 infection. Many countries like Italy, Spain, and the USA were ambushed by this viral agent. To date, more than 2.5 million people were infected with SARS-CoV-2. There is no clear answer, why SARS-CoV-2 infects so many people so fast. To date of April 2020, no effective drug has been found to treat this new severe viral infection. There are many therapy options under review and clinical trials were initiated to get clearer information, what kind of drug can help in this devastating and serious situation. The world has no time.

Reflections on FDA and WHO recommendations concerning clinical trials

1989 ◽  
Vol 4 (2) ◽  
pp. 117-122 ◽  
Author(s):  
J.-F. Dreyfus ◽  
D. Cremniter ◽  
J.D. Guelfi
Keyword(s):  
Clinical Trials ◽  
Drug Users ◽  
Objective Evaluation ◽  
World Health ◽  
Measuring Instruments ◽  
New Techniques ◽  
The Usa ◽  
The One ◽  
Health Organization

SummaryWe are still confronted by numerous different nosographic models and problems concerning the objective evaluation of patients progress during treatment. It is interesting to consider the consequences of this situation in psychiatry which still involves a relative diversity of practical methods used in clinical trials. The recommendations of the USA Food and Drug Administration, on the one hand, constitute a highly structured and precise reference. The World Health Organization, on the other hand, promulgates general recommendations resulting from a compromise designed to satisfy the greatest number of clinicians.Despite the apparently diverse principles and the different practical methods they propose, both those sets of recommendations have been useful in inspiring clinicians to reflect upon these different methodological approaches. The qualities of the inclusion criteria used in the study of patients and the sensitivity of the different measuring instruments have allowed psychotropic drug users as well as producers to recognize the need for a certain rigour in clinical trials.The FDA and WHO guidelines have certainly improved the quality of clinical trials in psychopharmacology. However, they also represent a source of resistance to innovation.A series of consensus meetings to first reconcile US and European points of view and later to include new techniques in the recognized sets of methods would therefore be helpful.

Evidence Against Maternal Influenza as a Risk Factor for Schizophrenia

1994 ◽  
Vol 164 (5) ◽  
pp. 674-676 ◽  
Author(s):  
J.-P. C. J. Selten ◽  
J. P. J. Slaets
Keyword(s):  
Risk Factor ◽  
Strong Evidence ◽  
Large Study ◽  
Second Trimester ◽  
Influenza Epidemic ◽  
Foetal Life ◽  
The Usa ◽  
Trimester Exposure ◽  
Larger Sample ◽  
Maternal Influenza

We tested the hypothesis that second-trimester exposure to influenza is a risk factor for schizophrenia in the child. The dates of birth of Dutch schizophrenic in-patients were examined for any effect of the 1957 A2 influenza epidemic. Individuals who were in their second trimester of foetal life at the peak of the epidemic were at no greater risk of developing schizophrenia than controls. As the present study has a larger sample size than all previous European studies, and is supported by a large study in the USA, it provides strong evidence against the hypothesis that second-trimester exposure to influenza is a risk factor for schizophrenia.

scholarly journals Characteristics of registered clinical trials assessing treatments for COVID-19: a cross-sectional analysis

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e039978 ◽  
Author(s):  
Hemalkumar B Mehta ◽  
Stephan Ehrhardt ◽  
Thomas J Moore ◽  
Jodi B Segal ◽  
G Caleb Alexander
Keyword(s):  
Clinical Trials ◽  
Clinical Investigation ◽  
Scientific Progress ◽  
Cross Sectional ◽  
Design Elements ◽  
Cross Sectional Analysis ◽  
Therapeutic Benefits ◽  
Wide Range ◽  
The Usa ◽  
Sectional Analysis

ObjectivesThe coronavirus disease 2019 (COVID-19) pandemic has prompted many initiatives to identify safe and efficacious treatments, yet little is known regarding where early efforts have focused. We aimed to characterise registered clinical trials assessing drugs or plasma treatments for COVID-19.Design, setting and participantsCross-sectional analysis of clinical trials for the treatment of COVID-19 that were registered in the USA or in countries contributing to the WHO’s International Clinical Trials Registry Platform. Relevant trial entries of drugs or plasma were downloaded on 26 March 2020, deduplicated, verified with reviews of major medical journals and WHO websites and independently analysed by two reviewers.Main outcome(s)Trial intervention, sponsorship, critical design elements and specified outcomesResultsOverall, 201 clinical trials were registered for testing the therapeutic benefits of 92 drugs or plasma, including 64 in monotherapy and 28 different combinations. Only eight (8.7%) products or combinations involved new molecular entities. The other test therapies had a wide range of prior medical uses, including as antivirals, antimalarials, immunosuppressants and oncology treatments. In 152 trials (75.7%), patients were randomised to treatment or comparator, including 55 trials with some form of blinding and 97 open-label studies. The 49 (24.4%) of trials without a randomised design included 29 single armed studies and 20 trials with some comparison group. Most trial designs featured multiple endpoints. Clinical endpoints were identified in 134 (66.7%) of trials and included COVID-19 symptoms, death, recovery, required intensive care and hospital discharge. Clinical scales were being used in 33 (16.4%) trials, most often measures of oxygenation and critical illness. Surrogate endpoints or biomarkers were studied in 88 (42.3%) of trials, primarily assays of viral load. Although the trials were initiated in more than 17 countries or regions, 100 (49.8%) were registered in China and 78 (37.8%) in the USA. Registered trials increased rapidly, with the number of registered trials doubling from 1 March to 26 March 2020.ConclusionsWhile accelerating morbidity and mortality from the COVID-19 pandemic has been paralleled by early and rapid clinical investigation, many trials lack features to optimise their scientific value. Global coordination and increased funding of high-quality research may help to maximise scientific progress in rapidly discovering safe and effective treatments.

scholarly journals Peptides in COVID-19 Clinical Trials—A Snapshot

Biologics ◽  
2021 ◽  
Vol 1 (3) ◽  
pp. 300-311
Author(s):  
Kai Hilpert
Keyword(s):  
Clinical Trials ◽  
Antiviral Activity ◽  
Russian Federation ◽  
Current Situation ◽  
Routine Diagnostics ◽  
Current Review ◽  
The Usa ◽  
The Russian Federation ◽  
The Uk

Since the beginning of the COVID-19 pandemic, there has been a strong drive and desire to find effective treatments for and protection against the disease. On the webpage ClinicalTrials.gov, a total of 6505 clinical trials currently (September 2021) investigating various aspects of COVID-19 are registered. Of these, 124 studies involving peptides were identified. These 124 were further evaluated, and 88 trials that used peptides only for routine diagnostics were excluded. The remaining 36 trials were classified into 5 different classes according to their function: immunomodulatory (5 trials), regain homeostasis (10 trials), diagnostics/biomarkers (8 trials), vaccination (9 trials), and antiviral activity (4 trials, all overlap with immunomodulatory activities). In the current review, these 36 trials are briefly described and tabularly summarised. According to the estimated finish date, 14 trials have not yet finished. All of the finished trials are yet to report their results. Seven trials were based in the USA, and Egypt, France, the UK, Turkey, and the Russian Federation conducted three trials each. This review aims to present a snapshot of the current situation of peptides in COVID-19 clinical trials and provides a template to follow up on trials of interest; it does not claim to be a complete overview.

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