Efficacy and Safety of SPILs Estradiol vaginal tablet, 10mcg estradiol in subjectswith Vulvar and Vaginal Atrophy: A Randomized, Observer blind, Parallel groups,Active and Placebo Controlled, Clinical Endpoint Bioequivalence Study

Sun Pharmaceutical Industries Ltd0 个研究点目标入组 405 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•(this particular trial does not have any specific age range and is meant for post menopausal women)
•1. Postmenopausal woman (defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/ml or 6 weekspostsurgical bilateral oophorectomy with or without hysterectomy)
•2. At least one subject-self-assessed moderate to severe symptom of vulvar and vaginal atrophy (VVA) from the list in Section 7.1.
•3. <= 5% superficial cells on vaginal smear cytology
•4. Vaginal pH > 5.0
•5. In women with an intact uterus, inactive endometrial lining and endometrial thickness
•<4 mm as documented on vaginal ultrasonography
•6. Women >40 years having documentation of a negative screening mammogram (obtained at screening or within 9 months of study enrollment)
•7. Normal clinical breast examination

•1. Taking estrogen alone or estrogen/progestin containing drug products. (Washout periods recommended before baseline assessments for subjects previously on estrogen alone or estrogen/progestin containing products as in Section 6.2.2)
•2. Known or suspected allergy to estradiol or related products
•3. Known, suspected or past history of breast cancer
•4. Abnormal genital bleeding
•5. History of significant risk factors for endometrial cancer
•6. Use of any type of vaginal or vulvar preparations, e.g. pessaries, contraceptive
•sponges, douches, vaginal moisturizers, or other non-oestrogenic medications including K-Y jelly etc., 1 month prior to first planned drug administration
•7. Known insulin dependent or non-insulin dependent diabetes mellitus
•8. Systolic blood pressure (BP) of more than 150 mm Hg and/or diastolic BP or more than 90 mm Hg, currently treated or untreated
•9. Active deep venous thrombosis or thromboembolic disorders or a history of these
•10. Active arterial thrombosis or a documented history of this condition
•11. Known or suspected liver and/or kidney impairment based on medical history, physical examination
•12. Known or suspected vaginal infection requiring further treatment
•13. Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
•14. Subject who has participated in any other trial involving other investigational products within the last 30 days prior to the first planned drug administration

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