CTRI/2026/01/100704招募中4 期
A prospective, open label, single-arm, multicentre, phase IV clinical trial to assess efficacy and safety of Dydrogesterone Extended-Release Tablets 20 mg in pregnant women with habitual miscarriages.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 4
研究概览
简要总结
This is a prospective, open label, single-arm, multicentre, phase IV clinical trial to assess efficacy and safety of Dydrogesterone Extended-Release Tablets 20 mg in pregnant women with habitual miscarriages.
The potential participants will be screened as per the inclusion and exclusion criteria only after obtaining their written informed consent.
The expected study duration will be approximately 12-15 weeks and will comprise of 04 study visits.
- Visit 01: Screening Visit (Upto Day -3)
- Visit 02: Enrolment Visit (Day 01 / Week 5 to 8 of gestation) and Start of Treatment
- Visit 03: Evaluation Visit (Week 12 of gestation)
- Visit 04: Evaluation Visit (Week 20 of gestation) and End of Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 39.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant woman aged 20 to 39 years (both inclusive at the time of screening).
- •Participants with unexplained recurrent miscarriages (based on a documented history of 2 or more spontaneous, consecutive miscarriages before 20 weeks gestation) with same partner.
- •Spontaneous conception (as confirmed by serum pregnancy test).
- •Presence of a viable pregnancy with gestational age of 5 to 8 weeks at the time of screening.
- •Positive urine pregnancy test within 2 weeks prior to screening (based on participant’s confirmation).
- •Body mass index (BMI) in the range of 18.5 to 29.9 kg/m2 (both inclusive).
- •Participants who are literate and with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •Participants who are willing and able to follow the study protocol to participate in the study.
排除标准
- •Participants with known hypersensitivity to dydrogesterone. 2) Participants who may have structural uterine anomalies like septate uterus, bicornuate uterus, fibroid, Asherman’s syndrome as assessed by Ultrasonography. 3) Participants with vaginal bleeding or severe abdominal pain requiring surgical intervention. 4) Participants with other clinically significant causes of miscarriage (endocrine disorders) identified during examination (including but not limited to pre-pregnancy diabetes, pre-pregnancy uncompensated thyroid dysfunction, history of malignant tumors or current tumors, PCOS, hyperprolactinemia). 5) Participants with evidence of clinically relevant cardiovascular, respiratory, urogenital, gastrointestinal, hepatic, hematological, immunologic, dermatologic, connective tissue, Musculo-skeletal, neurologic, psychiatric disorders, major surgery or other relevant disease as revealed by history, physical examination and/or laboratory assessments which might limit participation in, or completion of, the study. 6) Participants with presence of intrauterine fetus with a crown-rump length inappropriate for gestational age, with no visible heartbeat. 7) Participants with evidence of ectopic pregnancy 8) Participants with evidence of multiple pregnancy. 9) Participants with anembryonic pregnancy or fetal malformations as established causes of loss of previous pregnancies.
- •conceived on gonadotrophins or with the use of assisted reproductive technologies. 10) Participants with uterine myoma with submucosal location of the node (a clinically significant size as judged by the Investigator). 11) Participants with known or suspected progesterone dependent neoplasms 12) Participants with Sexually Transmitted Diseases (STDs) 13) Participants with an endocervical polyp. 14) Participants with autoimmune diseases such as but not limited to systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis. 15) Participants with coagulation disorder. 16) Participants with history of chemotherapy or radiotherapy. 17) Use of dydrogesterone or progesterone or hCG within 30 days prior to screening. 18) Participants with current or ongoing substance abuse, including alcohol and tobacco. 19) Participants with suspected inability or unwillingness to comply with the study procedures. 20) Participation in any other clinical trial within 30 days prior to screening. 21) Planned participation in any other trial during the entire duration of the study. 22) Participant with any clinically significant disorder that, in the opinion of the treating physician would result in jeopardizing participant’s safety and her inability to understand and comply with the requirements of the surveillance.
研究者
Dr Mehulkumar H Patel
Cliantha Research
研究点 (4)
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