EUCTR2016-002179-91-GB进行中（未招募）1 期
A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Provision of signed and dated informed consent prior to any study-specific procedures
- •2. Women 18 to 45 years of age (inclusive)
- •3. Oligo-/amenorrhea defined as =6 menstrual cycles per year off of any hormone therapy (may be based on subject historical recall)
- •4. At least one of the following during Screening:
- •Clinical signs of hyperandrogenism, where clinical hyperandrogenism may include hirsutism (defined as excessive terminal hair that appears in a male pattern), acne, or androgenic alopecia
- •Biochemical hyperandrogenism defined as an elevated serum androgen level (i.e., total, bioavailable or free testosterone level =ULN)
- •Polycystic ovarian morphology, defined as the presence of 12 or more follicles 2-9 mm in diameter and/or an increased ovarian volume >10 mL (without a cyst or dominant follicle) in either ovary
- •5. Body mass index (BMI) 22 to 45 kg/m2, inclusive
- •6. Must be willing to avoid use of all hair removal procedures (e.g., electrolysis, laser hair removal, plucking/tweezing, waxing, threading, etc.) and products (e.g., Vaniqa®, Nair™, etc.) during study participation in the areas of the scalp, upper lip, chin, chest, back, abdomen, upper arms and thighs
- •Note: Shaving is allowed; however, subjects must not shave within 72 hours prior to visits S1, T1 and T7 to permit assessment of hair growth
- •7. Must be willing to avoid all prescription treatments for acne and not increase the dose or frequency of their current non-prescription acne treatment regimen during study participation
- •8. Must be willing to avoid the use of all hair growth procedures (e.g., hair transplant) and products (e.g., minoxidil (Rogaine®)) during study participation
- •9. Must be willing to avoid the use of all of the other prohibited medications (including metformin, oral contraceptives, clomiphene, letrozole, spironolactone, finasteride and flutamide) and procedures during study participation (Sections 5.12, 5.13 and 5.14)
- •10. Permanently surgically sterilized (bilateral salpingectomy or tubal occlusion) >2 years or male partner(s) has had a vasectomy >2 years or must consent to use two permitted medically-acceptable methods of contraception throughout the study during any sexual intercourse with a male partner. Permitted medically-acceptable methods of birth control for this study are defined as use of a male condom plus one of the following: spermicide,
- •diaphragm with spermicide, or an intrauterine device that does not contain steroid hormones.
- •11. Must agree to not attempt to conceive during participation in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 220
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Menopausal or peri-menopausal, defined for this study as FSH >10 IU/L
- •2. Irregular vaginal/menstrual bleeding caused by conditions other than PCOS (e.g., uterine polyps or submucosal uterine fibroids)
- •3. Abnormal Papanicolaou (Pap) test during Screening requiring follow-up sooner than 1 year after the test (Note: Results from a Pap test performed within 1 year prior to Screening may be used)
- •4. Uncontrolled hypo- or hyperthyroidism, defined as having an abnormal TSH during Screening or Lead-in and/or change in thyroid medication dose within the month prior to Screening
- •5. Any suspected cause of hirsutism, acne, or alopecia other than PCOS
- •6. Post-hysterectomy or endometrial ablation
- •7. Post-oophorectomy (unilateral or bilateral) or other ovarian surgery
- •8. No menstrual periods during Lead-in (i.e., failed progestin challenge)
- •9. Two or more menstrual periods during Lead-in
- •10. Use of any of the following medications within 28 days prior to the start of Lead-in:
- •Metformin or other insulin-sensitizing medications (e.g., rosiglitazone, pioglitazone, etc.)
- •Hormonal contraceptives (e.g., birth control pills, hormone-releasing implants, etc.)
- •Hormone-releasing intrauterine device
- •Anti-androgens (e.g., spironolactone, flutamide, finasteride, etc.)
- •Clomiphene citrate or estrogen modulators such as letrozole
- •GnRH modulators such as leuprolide
- •Minoxidil
- •Note: Women who received every-3-month progestin challenge and no other hormonal therapy during the year prior to Screening and who did not have any menstrual bleeding other than that due to withdrawal from progestin challenge, may be randomized (if they meet all other inclusion/exclusion criteria) into the <4 menstrual cycles per year stratum.
- •11. Medical requirement for any of the prohibited concomitant medications
- •12. Medical history of type 1 or type 2 diabetes mellitus
- •13. Uncontrolled hypertension, defined as systolic blood pressure =160 mmHg or diastolic blood pressure =90 mmHg
- •14. Any history of gastric or small intestinal surgery or any current disease that causes malabsorption
- •15. Alcohol or substance abuse (cocaine, amphetamines and/or opioids) within the year prior to Screening
- •16. Abnormal laboratory values as per the guidelines listed below or any other clinically significant, unexplained laboratory abnormality according to the Investigator:
- •ALT or AST >2 times ULN
- •Total bilirubin >1.5 times ULN
- •Creatinine >1.5 times ULN
- •Fasting glucose >126 mg/dL (6.99 mmol/L)
- •Hemoglobin A1c >6.5%
- •Prolactin >ULN
- •17-hydroxyprogesterone >200 ng/dL (6nmol/L)
- •Total testosterone >150 ng/dL (5.21 nmol/L)
- •DHEA-S >800 µg/dL (21.6 µmol/L)
- •TSH >ULN or 17. Currently pregnant or breastfeeding or having conceived within the 3 months prior to Screening
- •18. QTc >470 msec on electrocardiogram at Screening or at Visit T1 (subjects with a single QTc >470 msec may have 2 additional ECGs taken and the QTcs averaged; if the average QTc is >470 msec then the subject is excluded)
- •19. History of Gilbert’s syndrome
- •20. HIV, hepatitis B, or hepatitis C positivity
- •21. Any malignancy within the previous 10 years, other than curatively resected basal or squamous cell skin cancer
- •22. Previous receipt of any amount of AZD4901 or AZD2624
- •23. Participation in any study of an investigational drug or device or investigational biological agent within 30 days (or 5 half-lives of the investigational agent, whichever is longer) prior to Screening
- •24. Any other medical or psychiatric condition (e
研究者
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