“A Phase III, Randomized, Double Blind, Single Dummy, Active Controlled, Prospective, Parallel Group, Comparative, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Dydrogesterone Sustained Release Tablets 30 mg versus Dydrogesterone Tablets 10 mg for the Treatment of Endometriosis in Women.â€
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 9
- 主要终点
- Mean change in endometriosis associated pelvic pain from baseline to end of the study, assessed by a visual analogue scale (VAS; 0 mm means absence of pain, 100 mm means unbearable pain).
研究概览
简要总结
Thistrial is a phase III, randomized, double blind, single dummy, activecontrolled, prospective, parallel group, comparative, multicentric clinicalstudy to evaluate the efficacy, safety and tolerability of DydrogesteroneSustained Release Tablets 30 mg versus Dydrogesterone Tablets 10 mg for thetreatment of endometriosis in women.
Patientswho are willing and able to participate in the study will sign and date theInformed Consent Form on the day of screening visit (Visit 1). During thisscreening period, patients who are willing to give consent will be evaluatedfor all the eligibility criteria. Eligible patients (female) aged 18 to 45 years(both inclusive), diagnosed with endometriosis based on imaging studies i.e.,USG and endometriosis associated pelvic pain having a score of at least 30 mmon a 100 mm visual analog scale at screening visit will be considered for thestudy.
After confirming the inclusion/exclusion criteria thesubject will be randomized and provided with study medication at randomizationvisit. Subjects will be provided with patient diary at randomization visit,which need to be brought along with in each subsequent visit till the lastvisit. Follow up visits will be done on day 30(±3), day 60(±3) and day 90(±3) (finalvisit) of treatment to assess efficacy, safety and tolerability.
Patientswill be assigned to either of the two arms i.e., Arm A or Arm B consisting of DydrogesteroneSustained Release Tablets 30 mg & Placebo Tablets or Dydrogesterone Tablets10 mg.
Patientswill be advised to take one tablet thrice a day orally, swallowed with water inthe morning, afternoon and evening around same time every day for 90 days.
TestProduct
DydrogesteroneSustained Release Tablets 30 mg & Placebo Tablets
Morning- One tablet of test product
Afternoon- One tablet of placebo matching test product
Evening- One tablet of placebo matching test product
ReferenceProduct
DydrogesteroneTablets 10 mg
Morning- One tablet of reference product
Afternoon- One tablet of reference product
Evening- One tablet of reference product
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients of aged between 18-45 years (both inclusive).
- •Patients diagnosed with endometriosis based on imaging studies i.e., USG.
- •Patients with endometriosis associated pelvic pain having a score of at least 30 mm on a 100 mm visual analog scale.
- •Patients having agreed to the use of double barrier contraception (use of the male condom along with either diaphragm, cervical cap, or copper T IUD).
- •Patients with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
- •Patients willing to comply with all the protocol requirements.
排除标准
- •Patients with intolerance, contraindication or potential allergy/hypersensitivity to Dydrogesterone.
- •Patients with laparoscopic surgery for endometriosis within 6 months before screening.
- •Female patients who are pregnant or lactating or planning to become pregnant during the study period.
- •Females who are not ready to use acceptable contraceptive methods during study.
- •Patients with previous use of hormonal agents (e.g., GnRH agonists ≤ 6 months, Danazol ≤ 3 months or oral contraceptives ≤ 1 month before screening).
- •Patients who have achieved menopause or have premature ovarian insufficiency.
- •Patients undergoing treatment for infertility by assisted reproductive technologies or any other procedure.
- •Patients with known case of clinically significant cerebrovascular disease, cardiovascular disease, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, hypertension, collagen disorders, severe infections, that may affect patient safety.
- •Patients with any other significant concomitant gynecological disorder (fibroid etc.).
- •Patients with active or recent (within 6 months) arterial thromboembolic disease (e.g., angina, myocardial infarction) or venous thromboembolism (deep vein thrombosis, pulmonary embolism) or at high risk of venous or arterial thrombosis.
- •Patients regularly using analgesics not intended to relieve endometriosis associated chronic pelvic pain (e.g., using analgesics for osteoarthritis etc.).
- •Patients with hepatic dysfunction (SGOT & SGPT ≥ 3 X Upper Normal Limit) or renal dysfunction (serum creatinine ≥ 2.5 mg/dL).
- •Patients with any abnormality detected on ECG at the time of screening.
- •Patients with history of drug or alcohol abuse.
- •Patients with medical history of oncological conditions.
- •Patients with known case of HIV, Hepatitis B & C.
- •Patients with concurrent participation in another clinical trial within 30 days prior to signing informed consent.
- •Patients currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •Patients with suspected inability or unwillingness to comply with the study procedures.
- •Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
结局指标
主要结局
Mean change in endometriosis associated pelvic pain from baseline to end of the study, assessed by a visual analogue scale (VAS; 0 mm means absence of pain, 100 mm means unbearable pain).
时间窗: At Screening Visit (Visit 1), | Visit 2 (Day 1 / Baseline), | Visit 3 (Day 30±3), | Visit 4 (Day 60±3) and | Visit 5 (Day 90±3).
次要结局
- Reduction in the size of the endometrioma as calculated by the Ultrasound sonography (USG) from baseline to end of the study.(At Screening Visit (Visit 1) and)
- Consumption of rescue pain medication for endometriosis associated pelvic pain from baseline to end of the study.(At Visit 3 (Day 30±3),)
- Changes in the health-related quality of life using the HRQoL-4 questionnaire from baseline to end of the study.(At Visit 2 (Day 1 / Baseline),)
- Adverse events / serious adverse events reported during the study.(Throughout the study.)
- Mean change in the serum vascular endothelial growth factor (VEGF) from baseline to end of the study.(At Screening Visit (Visit 1) and)
- Changes in clinical laboratory parameters from screening to end of the study visit.(At Screening Visit (Visit 1) and)