A Randomized, Double Blind, Placebo Controlled, Parallel Group, Comparative Clinical Study to Evaluate the Efficacy and Safety of OLNP-06 versus Placebo in Subjects with Primary Dysmenorrhea

Olene Life Sciences Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年2月21日

试验速览

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•Healthy Female subjects 18 â?? 35 years of age
•Regular menstrual cycle between 21 - 35 days with bleeding duration between three to seven days
•Suffering from primary dysmenorrhea
•Suffering from menstrual pain within the recent three consecutive months with a maximum VAS score of >=4
•Willing to sign the informed consent and comply with study procedure

•Diagnosis of secondary dysmenorrhea due to pelvic pathology, such as uterine fibroids, adenomyosis, endometriosis, or pelvic inflammatory diseases
•Female who is lactating, currently pregnant, intention to become pregnant.
•Current intrauterine device.
•Patient taking regular NSAIDs for some therapeutic indication for pain relief other than menstrual pain.
•Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies.
•History of psychiatric disorder that may impair the ability of subjects to provide written informed consent
•Metrorrhagia with menstrual cycles less than 21 days or oligomenorrhea with cycles over 40 days.
•Oral contraceptives or other hormonal treatment use within the past three months.
•Subject who is having allergic to ginger.

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