EUCTR2022-003219-26-DE进行中（未招募）1 期
An open-label, phase II, dose-finding study of three dose strengths of MR-130A-01 contraceptive transdermal patch containing norelgestromin (NGMN) in healthy pre-menopausal women
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 168
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Healthy, post-menarcheal and premenopausal women of age 18 to 35 years (inclusive).
- •2. BMI =18.0 kg/m2 at screening examination
- •3. Subjects must be in good physical and mental health as determined by vital signs, medical history, and physical and gynecological examination, as assessed by the investigator.
- •4. Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the subject participating in the clinical trial.
- •5. Status at least 3 months after a delivery, abortion, and stopping lactation, if applicable, before screening.
- •6. Has regular menstrual cycles that are between 21 and 35 days in duration as reported by the subject during anamnesis, with an intact uterus and ovaries. If the subject uses hormonal birth control at screening, historic data should be used to evaluate this criterion.
- •7. Both ovaries must be visible on TVUS examination during screening.
- •8. Ovulatory pre-treatment cycle, as confirmed by a progesterone concentration >10.0 nmol/L.
- •9. Subjects must consent to use reliable non-hormonal contraceptive methods (male condoms, diaphragm, or heterosexual abstinence) throughout the study, unless the subject has a history of female sterilization or sterilization of the sexual partner.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 168
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known hypersensitivity or intolerance to any ingredient of the investigational product
- •2. History or presence of dermal sensitivity to medicated patches or to topical applications including bandages, surgical tape
- •3. Pregnancy or a positive serum beta human chorionic gonadotropin (ß-hCG) pregnancy test at screening
- •4. Clinically relevant abnormal findings from serum biochemistry and hematology and HBsAg and Hepatitis C virus/human immunodeficiency virus (HIV) serology as evaluated by the investigator
- •5. ASAT > 20 % ULN, ALAT > 10 % ULN, bilirubin > 20% ULN (except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history) and creatinine > 0.1 mg/dL ULN (limit of > 0.1 mg/dL corresponds to > 9 µmol/l ULN)
- •6. Use of a non-hormonal intra-uterine device within the pre-treatment cycle or any hormonal contraception as follows:
- •Short-acting hormonal contraceptives such as oral, patch, ring or intra-uterine systems within the menstrual cycle prior to the pre-treatment cycle
- •Injectable (intramuscularly or subcutaneously) within 10 months (three-month treatment duration), 6 months (two-month treatment duration) or 3 months (one-month treatment duration) prior to the start of pre-treatment cycle or implants within the menstrual cycle prior to the pre-treatment cycle
- •7. Known or suspected malignancy or history thereof
- •8. Has unexplained vaginal bleeding within the past 6 months suspicious for serious condition, or any abnormal bleeding which is expected to recur during the study (eg. bleeding from cervical polyp, recurrent bleeding after sex)
- •9. History or presence of ischemic heart disease, coronary artery disease, myocardial infarction, stroke, other cerebrovascular diseases including transient ischemic attacks (TIAs)
- •10. Known dyslipidemias with other known cardiovascular risk factors
- •11. History or presence of hypertension (including adequately controlled hypertension) or hypertension with vascular disease or elevated BP defined as systolic BP =140 mm Hg or diastolic BP =90 mm Hg, measured in sitting position after at least 5 minutes of rest (a single reading of blood pressure level is not sufficient to classify a woman as hypertensive)
- •12. Pulse rate < 50 bpm or > 90 bpm
- •13. Presence of deep vein thrombosis/pulmonary embolism
- •14. Has any comorbid condition that may require major surgery with prolonged immobilization during the study period
- •15. History or presence of migraine with aura
- •16. Presence of liver disease including severe (decompensated) cirrhosis, benign (e.g., hepatocellular adenoma) or malignant liver tumors
- •17. Chronic disease potentially necessitating organ transplantation during the anticipated course of the study
- •18. Subjects having any other known contraindication to progestin only contraception as defined by category 3 or 4 conditions per World Health Organization Medical eligibility criteria for contraceptive use, 2015 or Centers for Disease Control and Prevention (CDC) US Medical Eligibility Criteria (US MEC) for Contraceptive Use, 2016 (WHO 2015, Curtis KM et al., 2016)
- •Multiple risk factors for arterial cardiovascular disease (such as older age [35 years at screening or during the study], smoking, diabetes, hypertension and known dyslipidemias)
- •History or presence of systemic lupus erythematosus with positive (or unknown) antiphospholipid antibodies
- •History (even with no evidence of current disease for 5 years) or presence of or suspected carcinoma of breast
- •Has diabetes mellit
研究者
相似试验
进行中（未招募）
不适用
A phase Ib study to determine the maximum starting dose and to evaluate safety, pharmacokinetic and efficacy profiles of INC424 in myelofibrosis patients who have thrombocytopenia.EUCTR2010-023055-29-NLovartis Pharma Services AG62
进行中（未招募）
不适用
A Phase Ib, open-label, dose-finding study of the JAK inhibitor INC424 tablets administered orally to patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF) and baseline platelet counts = 50 x109/L and <100 x109/Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF)MedDRA version: 14.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2010-023055-29-ATovartis Pharma Services AG62
进行中（未招募）
不适用
A Phase Ib, open-label, dose-finding study of the JAK inhibitor INC424 tablets administered orally to patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF) and baseline platelet counts = 50 x109/L and <100 x109/EUCTR2010-023055-29-GBovartis Pharma Services AG62
已完成
不适用
A Phase Ib, open-label, dose-finding study of the JAK inhibitor INC424 tablets administered orally to patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF) and baseline platelet counts * 50 x109/L and <100 x109/L (CINC424A2201)myelofibrosemyelofibrosisNL-OMON39946ovartis Pharma BV3
尚未招募
1 期
A clinical trial to evaluate the effects of vaccine in patients of Pancreatic cancerCTRI/2016/05/006953Dr Arun Maseeh Study Director Cadila Pharmaceuticals Ltd38