CTRI/2022/03/041372招募中3 期
â??A Phase III, Randomized, Open Label, Parallel Group, Active Controlled,Comparative, Multicentric Clinical Study to Evaluate the Efficacy and Safety of Mifepristone 10 mg and 25 mg tablets compared with Leuprolide acetate 3.75 mg intramuscular injection in the preoperative treatment of moderate tosevere symptomatic uterine fibroids.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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
入选标准
- •1. Premenopausal woman between 18 to 40 years of age (both inclusive).
- •2. Subjects having uterine bleeding caused by fibroids.
- •3. Subjects having Body mass index (BMI) of 18 to 40.
- •4. Subjects having uterine size equivalent to at least 10 weeks and no more than 16 weeks of gestation in a gravid uterus.
- •5. Subjects having myomatous uterus with at least one uterine myoma of >= 3 cm diameter in size and no myoma larger than 10 cm diameter in size diagnosed by transvaginal ultrasound.
- •6. Subjects with the presence of one or more of the following symptoms: menorrhagia, dysmenorrhea, pelvic pressure, abdominal lump, dull aching lower abdominal pain, or dyspareunia.
- •7. Subjects having myoma related anaemia (Blood haemoglobin <12 g/dL).
- •8. Subjects having clinical breast examination without significant findings at screening visit.
- •9. Subjects of childbearing potential must be practicing conventional contraceptive methods such as sexual abstinence, barrier methods, diaphragms, condom or partner with a vasectomy, male or female
- •sterilization performed at least 6 months prior to screening and confirmed azoospermia.
- •10. Subjects who are able to understand and give voluntary, written informed consent to participate in this clinical investigation and from whom IEC/IRB approved written informed consent has been obtained.
- •11. Subjects shall be willing and able to understand and comply with the requirements of the study, administer the medication as instructed, return for the required treatment period visits, comply
- •with therapy prohibitions, and be able to complete the study.
排除标准
- •1. Subjects with history of uterus surgery (except caesarean section or cervical conisation), endometrial ablation or uterine artery embolization.
- •2. Subjects with history of or current uterine, cervical, ovarian or breast cancer.
- •3. Subjects with history of atypical hyperplasia or a current endometrium hyperplasia (atypical or non-atypical) or adenocarcinoma or similar lesions in the endometrial biopsy during screening visit or in a biopsy performed within the past 6 months.
- •4. Subjects having a condition requiring immediate blood transfusion or severe anaemia defined as blood haemoglobin level of <6 g/dL.
- •5. Subjects having a known hemoglobinopathy (i.e. Sickle cell anaemia and Thalassemia).
- •6. Subjects having known any coagulation disorder.
- •7. Patients using any other contraceptive method other than conventional methods.
- •8. Subjects having concomitant adenomyosis.
- •9. Subjects having a large uterine polyp ( > 2 cm) diagnosed by transvaginal ultrasound.
- •10. Subjects having one or more ovarian cysts >= 4 cm in diameter diagnosed by transvaginal ultrasound.
- •11. Subjects with a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRHagonist.
- •12. Subjects taking treatments with progestins (systemic or progestin releasing intra-uterine system) or an oral contraceptive within one month prior to screening visit.
- •13. Subjects taking acetylsalicylic acid, mefenamic acid, anticoagulants such as cumarins and/or antifibrinolytic drugs such as tranexamic acid within one week prior to screening visit.
- •14. Subjects taking systemic glucocorticoid treatments and/or systemic depot glucocorticoid treatments within one week or two months prior
- •to screening visit, respectively.
- •15. Subjects with history of or known current osteoporosis.
- •16. Subjects with genital bleeding of unknown etiology or for reasons other than uterine fibroids.
- •17. Subjects with current history of severe asthma.
- •18. Subjects with abnormal eGFR ( < 60 mL/min/1.73 m2) will be excluded from the study.
- •19. Subjects with abnormal Liver Function Test with values more than 2.5 times the upper limit of normal.
- •20. Subjects with known case of Oncological Conditions.
- •21. Subjects with known case of HIV infection, hepatitis B, or hepatitis C Infection.
- •22. Subject with any clinically significant laboratory abnormalities at screening visit.
- •23. Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •24. Subjects who are pregnant or lactating or planning to become pregnant during the study period.
- •25. Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study
- •26. Subjects who consume abuse drugs, or have any condition that would compromise compliance with this protocol.
- •27. Subjects who have been treated with an investigational drug or investigational device within a period of 4 weeks prior to study entry.
- •28. Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •29. Suspected inability or unwillingness to comply with the study procedures.
研究者
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