An Open Label, Multi-Center, Randomized, Two Arm, Phase III Clinical Trial toEvaluate Efficacy and Safety of Thymosin alpha one plus Standard of Care (SOC) in Comparisonwith SOC Alone in Patients with Confirmed Endometriosis

Gufic Biosciences Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•1. Female patients between the age group =18and = 49 years of age at the time of
•2. Patients with a confirmed diagnosis of Endometriosis (up to stage III) based on
•laparoscopy or imaging
•3. Patients having negative urine pregnancy test at the time of screening and agree to
•the use of barrier contraception during the study period
•4. Patients who are willing to comply with study procedures and restrictions
•5. Patients who can and are willing to provide signed informed consent

•1. Patient with a surgical history of hysterectomy, bilateral adnexectomy, endometrial
•ablation resulting in amenorrhea
•2. Candidate for elective gynaecological surgery [Dilation and Curettage (D&C),
•cervical cryosurgery, colposcopy, Loop Electrosurgical Extension Procedure
•(LEEP)] for next 6 months
•3. Patient who had a normal or C section delivery with a gap of less than 3 months
•after cessation of Lactation
•4. Participation in other clinical trials in last three months and during study period
•5. Patients having an unstable medical condition or chronic disease (including history
•of neurological [including cognitive], hepatic, renal, cardiovascular,
•gastrointestinal, pulmonary, or endocrine disease), or malignancy that could
•confound interpretation of the study outcomes
•6. Patients having a history of positive human immunodeficiency virus antibody (HIV
•Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV-Ab)
•assay at Screening or have a history of a positive result
•7. Pregnant and lactating female lactating at the time of screening and willing to
•continue lactating during the study
•8. Any other condition, which as per the investigator would jeopardize the outcome of
•9. Patients who, in the judgment of the investigator, will be unlikely to comply with
•the requirements of this protocol

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