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临床试验/NCT03749109
NCT03749109已完成2 期

A Randomised, Double-blind, Placebo-controlled, Proof-of-mechanism Phase 2 Trial Investigating the Effect of Quinagolide Extended-release Vaginal Ring on Reduction of Lesions Assessed by High-resolution Magnetic Resonance Imaging in Women With Endometrioma, Deep Infiltrating Endometriosis, and/or Adenomyosis

Ferring Pharmaceuticals11 个研究点 分布在 4 个国家目标入组 67 人开始时间: 2019年8月19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
67
试验地点
11
主要终点
Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4
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

This will be a randomized, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep infiltrating endometriosis, and/or adenomyosis.

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 45 Years（Adult）
性别
Female
接受健康志愿者
否

入选标准

  • •Pre-menopausal women between the ages 18-45 years (both inclusive) at the time of signing the informed consent
  • •Body mass index (BMI) of 18-35 kg/m2 (both inclusive) at screening
  • •Confirmation of deep infiltrating endometriosis (DIE), endometrioma or adenomyosis by high-resolution MRI at screening
  • •Transvaginal ultrasound (TVU) documenting a uterus with no abnormalities of endometrium and presence of at least one ovary with no clinically significant abnormalities at screening. Note that presence of uterine fibroids are not exclusionary but presence of any submucosal fibroids or polyps are exclusionary
  • •Willing and able to use a non-hormonal single-barrier method (i.e. condom) for contraception from the start of screening to the end-of-treatment. This is not required if adequate contraception is achieved by vasectomy of the male sexual partner, surgical sterilisation (e.g. tubal ligation and blockage methods such as ESSURE) of the subject, or true abstinence of the subject (sporadic sexual intercourse with men requiring condom use)
  • •Willing to avoid the use of vaginal douches or any other intravaginally administered medications or devices (except for tampons) from randomization to the end of treatment

排除标准

  • •Use of depot medroxyprogesterone acetate (MPA) within 10 months prior to the screening visit.
  • •Use of gonadotropin-releasing (GnRH) agonists (3-month depot) or dopamine agonists within 6 months prior to the screening visit.
  • •Use of GnRH agonists (1-month depot or nasal spray), GnRH antagonists, aromatase inhibitors, danazol, birth control implants (e.g. NEXPLANON), progestogen or levonorgestrel releasing intrauterine device (IUD) within 3 months prior to the screening visit.
  • •Use of hormonal contraceptives (including combined oral contraceptive pill, transdermal patch, and contraceptive ring) within 1 menstrual cycle prior to the screening visit.
  • •Contraindications to MRI such as having internal/external metallic devices and/or accessories (e.g. cardiac pacemakers and leg braces)

研究组 & 干预措施

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 Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4

时间窗: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)

The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis.

次要结局

  • Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4(At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4(At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days))
  • Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4(At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months))
  • Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4(At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months))
  • Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration)(At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months))
  • Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4(Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months))
  • Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Bilirubin(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4(Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months))
  • Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration)(At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months))
  • Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4(Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months))
  • Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4(Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months))
  • Changes in Clinical Chemistry and Hematology Parameters: Hematocrit(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Leukocytes(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Calcium(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Platelets(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Albumin(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Cholesterol(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Creatinine(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Chloride(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Glucose(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Phosphate(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Protein(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Urate(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Frequency and Intensity of Adverse Events(From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Potassium(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Sodium(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))
  • Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters(At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (11)

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