An open-label, single-center, investigator-initiated, randomized, pilot study to determine the efficacy and safety of 2.5X Placentrex Placentrex (Human Placental Extract) Injections in Recurrent Pelvic Inflammatory Disease (PID).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The proportion of patients with excellent, good, and poor responses based on the Clinical Global Impression Scale (CGI) at 2 and 12 weeks.
研究概览
简要总结
This open-label, single-center, investigator-initiated pilot study aims to evaluate the efficacy and safety of 2.5X Placentrex (Human Placental Extract) Injections in treating Recurrent Pelvic Inflammatory Disease (PID). PID is an infection of the upper reproductive organs, which can lead to severe complications if untreated. The study compares the non-inferiority of 2.5X Placentrex Injections (0.1gm of placental extract in 2 ml) for 10 and 7 days with the standard 14-day Placentrex Injection treatment.The study involves 45 participants, divided into three groups, each receiving different treatment durations. The primary objective is to assess the efficacy of the investigational product, while the secondary objective focuses on safety. Participants will undergo a 12-week study period, including screening, treatment, and follow-up. Efficacy will be measured using the Clinical Global Impression Scale, and safety will be monitored through adverse event reporting and physical examinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women of childbearing age group of 20 to 40 years.
- •Patients had a history of PID (not more than 12 months from the screening) with pain in lower abdomen, dysmenorrhoea, dyspareunia or vaginal discharge.
- •Patients came with complaints of lower abdominal or pelvic pain and cervical motion, pelvic tenderness, or adnexal tenderness and were diagnosed with recurrent (more than 2 episodes) PID.
- •Patients came with primary or secondary infertility with PID.
- •Patients had persisted PID despite antibiotic treatment within 6 weeks preceding enrolment.
- •Patients are willing to receive intramuscular (IM) injections for at least 14 days.
- •Patients who are willing to provide written informed consent prior to the performance of any study-specific procedures.
- •Patients with a negative urine/serum pregnancy test at the time of screening.
- •Patients who are willing to use effective methods of contraceptives during the study period.
- •Patients who are willing and able to comply with all study assessments and adhere to the protocol schedule.
排除标准
- •Postmenopausal women.
- •Patients on active treatment or with evidence of active tuberculosis/sexually transmitted disease (STD).
- •History of more than 3 episodes of documented PID/bacterial STD.
- •Patients with known endometriosis.
- •Pregnant or lactating women.
- •History or presence of ovarian cyst, malignancy.
- •Patients who are on the medication are likely to interfere with the study.
- •Patients who are unwilling or unable to give written informed consent.
- •Patients involved in clinical trials and taken investigational drugs within 30 days of enrolment.
- •Any severe, acute or chronic medical condition that may affect the patients ability to participate in the study, may lead to unacceptable security risks and non-compliance with protocol procedures or may interfere with the interpretation of the study results.
结局指标
主要结局
The proportion of patients with excellent, good, and poor responses based on the Clinical Global Impression Scale (CGI) at 2 and 12 weeks.
时间窗: Baseline through week-2 and week-12
次要结局
- Relapse/recurrence rate of PID symptoms.(at 12 weeks.)
研究者
Dr Pathak Urvashi Mahenndrakumar
MBBS, MD, DNB