An Open label, Randomized, Multicentric, Parallel group, 4 arm, comparartive phase III study to evaluate the Efficacy and Safety of Progesterone SR oral tablets versus Progesterone oral tablets in women with secondary amenorrhea associated with normal estrogen levels.

Synokem Pharmaceuticals Ltd0 个研究点目标入组 388 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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•1.Non hysterectomized women of the age of 25 to 45 years.
•2.Women whose menstrual cycles disappear for 6 consecutive months with irregular menses or for 3 consecutive months with regular menses
•3.Women willing to give informed consent

•1.Women with hypersensitivity to any of the test or control formulation drugs or their excipients
•2.Pregnant or nursing women
•3.Women of childbearing potential not using medically approved means of contraception
•4.History of drug or alcohol abuse
•5.Women who are in menopause phase
•6.Women with undiagnosed irregular vaginal bleeding
•7.Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy will be excluded from the study
•8.Women with malignancy (uterine breast) or with family history of malignancy
•9.Women with gall stone disease
•10.Women with DVT or history of CVD
•11.Women with thyroid disease
•12.Women with ovarian failure
•13.Women with Ashermans Syndrome

发起方