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临床试验/NCT03692403
NCT03692403已完成2 期

A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial Assessing the Efficacy, Safety and Dose-response of Quinagolide Extended-release Vaginal Rings Administered Sequentially for 4 Menstrual Cycles in Women With Moderate to Severe Endometriosis-related Pain

Ferring Pharmaceuticals43 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年12月26日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
22
试验地点
43
主要终点
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the efficacy of three doses of quinagolide administered as an extended-release vaginal ring compared to placebo on reduction of moderate to severe endometriosis-related pain

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
Female
接受健康志愿者
否

入选标准

  • •Pre-menopausal females aged ≥18 years at time of signing informed consent(s) with regular menstrual cycles.
  • •Body mass index (BMI) of 18-42 kg/m2 (both inclusive) at screening.
  • •Initial confirmation of endometriosis by laparoscopy or laparotomy within the last 10 years before the run-in visit or visualization of persistent endometrioma by repeat ultrasound.
  • •Transvaginal ultrasound documenting a uterus with no clinically significant abnormalities and presence of at least one ovary with no clinically significant abnormalities (with the exception of endometrioma) at the run-in visit.
  • •Eligible participants experienced moderate to severe endometriosis-related pain, which was defined as at the run-in visit, the participant having an NRS score of ≥5 for the worst endometriosis related pain during the past menstrual cycle and at randomization, the participant having a mean daily NRS score of ≥4 for the worst endometriosis related pain during each run-in menstrual cycle.

排除标准

  • •History of no relief of endometriosis related pain after any medical therapy or surgery. However, history of partial pain relief, discontinuation due to side effects are not exclusionary.
  • •Known bone diseases (e.g. osteoporosis, Paget's disease and osteomalacia) affecting bone resorption or bone formation markers.
  • •Any significant abnormal findings of heart examinations before randomization.
  • •History of mental illness including occurrence of acute psychosis, bipolar disorders and schizophrenia (except for well-controlled anxiety and/or depression with no changes to interventions for 6 months prior to start of run-in)
  • •History of impulse control disorders including pathological gambling, compulsive buying, hypersexuality, and binge eating or being identified with potential impulse control disorder by the questionnaire for impulsive-compulsive disorders (a score ≥2 for any sub-questions of Question 3 or a score ≥1 for any sub-questions of Question 4) prior to randomization.
  • •History of orthostatic hypotension or recurrent syncope.

研究组 & 干预措施

Quinagolide 360 µg

Experimental

Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg

干预措施: Quinagolide 360 µg (Drug)

Quinagolide 720 µg

Experimental

Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg

干预措施: Quinagolide 720 µg (Drug)

Quinagolide 1080 µg

Experimental

Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg

干预措施: Quinagolide 1080 µg (Drug)

Placebo

Placebo Comparator

Vaginal ring containing matching placebo

干预措施: Placebo (Drug)

结局指标

主要结局

Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.

时间窗: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)

Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes from baseline to cycle 4.

次要结局

  • Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse.(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Frequency of Avoiding Sexual Intercourse Due to Expected Pain(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding(At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea.(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in Vaginal Bleeding Pattern.(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in the Mean Individual and Total Symptom and Sign Severity Scores(At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Patient Global Impression of Change (PGIC) Scores(At cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Serum Levels of Prolactin(At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days))
  • Serum Levels of Insulin-like Growth Factor-1 (IGF-1)(At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days))
  • Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain.(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain.(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Percentage of Days With Mild and/or Strong Rescue Analgesics Used(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Responder Rate(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in Patient Global Impression of Severity (PGIS) Scores(At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Plasma Concentration of Quinagolide and Metabolites(Within 5 days after first ring insertion and at around 1 month, 3 months, 3.5 months and 4 months after baseline (each cycle is approximately 28 days))
  • Serum Levels of Mid-luteal Phase Progesterone(At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days))
  • Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml)(At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days))
  • Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function.(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in Bone Turnover Markers, Determined by Bone Resorption Marker Serum C-terminal Crosslinking Telopeptide of Type 1 Collagen (s-CTx)(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in Bone Turnover Markers, Determined by Bone Formation Marker Serum Procollagen Type I N Propeptide (s-PINP)(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Total and Average Doses of Mild and/or Strong Rescue Analgesics Used(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in the Endometriosis Health Profile-30 (EHP-30) Scores(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Serum Levels of Estradiol(At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days))
  • Serum Levels of Thyrotropin (TSH)(At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Calcium(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in ECG Parameters Including PR Interval at Cycle 4(At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in ECG Parameters Including QRS Duration at Cycle 4(At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in ECG Parameters Including QT Interval at Cycle 4(At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in ECG Parameters Including QTcF Interval at Cycle 4(At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Proportion of Subjects With Abnormal Clinically Significant Echocardiography Findings Indicating Valvular Heart Disease(At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Proportion of Subjects Identified With Potential Impulse Control Disorders(At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Frequency and Intensity of Adverse Events(From signing informed consent through study completion, around 8 months)
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Albumin(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Alkaline Phosphatase(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Alanine Aminotransferase(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Aspartate Aminotransferase(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Bicarbonate(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Creatinine(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Glucose(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Direct Bilirubin(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Bilirubin(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Gamma Glutamyl Transferase(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Lactate Dehydrogenase(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Chloride(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Basophils Absolute(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Platelets(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Erythrocytes(At baseline and at menstrual cycle 4 (around 4 months))
  • Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity)(At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Haematology Parameters(At baseline and at menstrual cycle 4 (around 4 months))
  • Proportion of Subjects With Markedly Abnormal Changes in Urinalysis Parameters(At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Cholesterol(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Hematocrit(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Leukocytes(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Potassium(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Phosphate(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Protein(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Sodium(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Hemoglobin(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes Absolute(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Hemoglobin(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Urate(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Chemistry Parameters: Urea Nitrogen(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Basophils(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils Absolute(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular HGB Concentration(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Volume(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes Absolute(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils Absolute(At baseline and at menstrual cycle 4 (around 4 months))
  • Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Chemistry Parameters(At baseline and at menstrual cycle 4 (around 4 months))
  • Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring(From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes(At baseline and at menstrual cycle 4 (around 4 months))
  • Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils(At baseline and at menstrual cycle 4 (around 4 months))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (43)

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