CTRI/2022/03/041189招募中2 期
An Open-label, Randomized, 2-Period, Crossover Study to Assess the Comparative Pharmacokinetics of LSP-5415 and NuvaRing�® in Healthy Adult Females
upin Research Inc0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Must be able, and willing, to sign Informed Consent Form prior to
- •study participation in accordance with legal requirements.
- •2. Females (18 to 40 years of age, inclusive) without uncontrolled
- •concomitant disease at Baseline Visit.
- •3. Have a regular menstrual cycle that is 24-32 days in duration.
- •4. Body Mass Index (BMI) of 18 kg/m2 to 30 kg/m2.
- •5. Will not be at risk for pregnancy, subjects must agree to consistently use reliable non-hormonal contraceptive methods (spermicide-coated condoms, male partnerââ?¬•s sterilization via vasectomy, or sexual abstinence), or be in a same-sex relationship from screening through study completion, or be surgically sterilized by bilateral tubal ligation.
- •6. Subjects must be in good physical and mental health as determined by vital signs, medical history.
- •7. Subjects must have a Blood Pressure reading in a sitting position,
- •between 90-140 mmHg (systolic) and 50-90 mmHg (diastolic) and
- •pulse rate between 50 and 100 bpm.
- •8. Be at least 3 months after a delivery or abortion.
- •9. Willing to abstain from vaginal products e.g., tampons, intravaginal medications etc. during the ring wear period for the study duration except water based vaginal lubricants/spermicides.
排除标准
- •1. Pregnancy, a positive serum Ã?Ÿ-hCG pregnancy test at screening or
- •2. Use of tobacco- or nicotine-containing products within 6 months prior to check-in on Day 1.
- •3. history of cervical carcinoma or other carcinomas of the vagina or vulva.
- •4. history of breast cancer or any hormonally sensitive cancer.
- •5. Subjects with abnormal pap smears that require colposcopic
- •evaluations as defined by the fourth American Society of Colposcopy and Cervical Pathology sponsored guidelines for management of cervical cancer abnormalities during the next 6
- •months are excluded until they have undergone colposcopic
- •evaluation which has determined that a cervical procedure is not
- •necessary during the 6 months following the colposcopy.
- •6. History of thrombophlebitis, venous or arterial thromboembolic
- •7. Any known severe neurological, gastrointestinal, hepatic or other
- •disease that might interfere with the intake of an investigational drug
- •or any study condition.
- •8. Clinically relevant findings from serum biochemistry and hematology and HBsAg and C Virus/HIV serology.
- •9. Clinically relevant/significant ECG findings.
- •10. Additional contraindications related to the use of ethinyl estradiol (EE), or hormonal contraceptives including women with a high risk of arterial or venous thrombotic diseases. Have cerebrovascular disease, coronary artery disease, thrombogenic valvular or thrombogenic rhythm diseases of
- •the heart, inherited or acquired hypercoagulopathies, uncontrolled hypertension, diabetes mellitus with vascular disease, headaches with focal neurological symptoms or migraine headaches with aura 11. History of migraine with focal neurological symptoms.
- •12. Known hereditary or acquired predisposition for venous and or
- •arterial thromboembolism.
- •13. Less than 2 weeks remobilization after major surgery or prolonged immobilization
- •14. Alcohol, drug, or medicine abuse, or suspicion thereof.
- •15. Known allergy to any ingredient of the investigational drug.
- •16. Use of long acting injectable or implant hormonal therapy. A
- •washout period of 10 months and two regular cycles is required for
- •long-acting injectable contraceptive therapy or implant hormonal
- •therapy prior to the start of screening.
- •17. Use of hormonal or non hormonal IUDs within 30 days prior to the start of screening.
- •18. Participation in another clinical trial at same time or within the
- •preceding three months
- •19. Not fulfilling study specific requirements at screening.
- •20. Subjects desire to become pregnant during the Study.
- •21. Undiagnosed vaginal discharge/bleeding, vaginal lesions/
- •abnormalities or undiagnosed abnormal uterine bleeding. Subjects
- •suspected of having a vaginal infection may be enrolled after treatment and subsequent negative test results; partner treatment is also recommended.
- •22. Regular intake or use of the following medication:
- •a. any drugs that might interfere with the investigational drug.
- •b. any hormonal preparation 30 days prior to the start of screening.
- •c. any drugs known to induce liver enzymes.
- •e. any broad-spectrum antibiotics.
- •f. use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without das
研究者
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