EUCTR2020-000412-30-CZ进行中（未招募）1 期
A multicenter, open-label, controlled study to investigate the effect of either LF111 or Drospirenone chewable tablets on bone mineral density (BMD) in adolescent and adult women in comparison with non-users of hormonal contraceptive methods.
Chemo Research S.L.0 个研究点目标入组 1,362 人开始时间: 2022年5月5日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,362
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Female subjects with regular menstrual cycles (postmenarcheal for at least two years and premenopausal) aged 18 to 45 years.
- •2. Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg at Visit 1, in sitting position after 5 minutes of rest.
- •3. Menstruation restarted for at least 6 months since last pregnancy (only applicable for women that were pregnant).
- •4. Be able and willing to provide written informed consent, prior to undergoing any trial-related procedures.
- •5. Willing to use trial contraception for thirteen 28-day cycles (hormonal treatment arm) or to use non-hormonal contraceptive methods for the duration of the trial (non-hormonal contraceptive arm), respectively.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 712
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 650
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Contraindications to the use of LF111 (such as active arterial or venous thromboembolic disorders, liver tumors benign or malignant, hepatic impairment, renal impairment, adrenal insufficiency, presence or history of cervical cancer or progestin-sensitive cancers, known or suspected sex-steroid sensitive malignancies, undiagnosed abnormal uterine bleeding, undiagnosed vaginal bleeding, hypersensitivity to active substance or excipient) or adverse effects due to previous contraceptive use (for the hormonal treatment arm only).
- •2. BMD Z-score below -1.50.
- •3. Low trauma fracture(s) defined as a fracture that results from a fall from a standing height or less, excluding fingers, toes, face and skull.
- •4. Medical conditions associated with low bone mass:
- •a. Metabolic bone disease such as osteogenesis imperfecta, Paget’s disease of the bone, osteomalacia/rickets
- •b. Collagen vascular diseases such as Marfan’s syndrome and Ehlers-Danlos syndrome
- •c. Chronic kidney disease stage 3 with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 using the Modification of Diet in Renal Disease (MDRD) method for adult subjects
- •d. Gastrointestinal (malabsorptive) disease including inflammatory bowel disease, gastric bypass surgery and current postgasrectomy syndrome
- •e. Liver disease
- •f. Abnormal bone mineral metabolism (hypocalcemia/hypercalcemia, hypophosphatemia/hyperphosphatemia, hypomagnesemia).
- •5. In adolescents only: Short stature defined as height-for-age percentile less than the fifth percentile - Not applicable for the Czech Republic.
- •6. Use of progestin-only contraceptive pills in the previous month or use of implantable hormonal contraceptives in the previous 6 months.
- •7. Laboratory values at Screening which are considered clinically significant and which in the opinion of the investigator would be detrimental for participation in the study.
- •8. Ongoing pregnancy or wish for pregnancy.
- •9. Currently lactating or stopped lactating within the last 12 months
- •10. Eating disorders (e.g., anorexia nervosa, bulimia).
- •11. Celiac disease.
- •12. Endocrine disorders (e.g., diabetes, hypothyroidism or hyperthyroidism, hyperparathyroidism, Cushing's disease) not adequately controlled with a stable treatment regimen for > 2 months.
- •13. Rheumatoid arthritis.
- •14. Current or ever use of medications or supplements known to increase BMD including bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab, calcitonin, fluoride and strontium.
- •15. Treatment with medications that are known to decrease bone mass:
- •Glucocorticoids (oral, intravenous, chronic inhaled or chronic extensive topical [> 3 months]) within the previous 3 months.
- •Note: Subjects taking chronic oral/intravenous glucocorticoids (prednisone = 2.5 mg daily for = 3 months, or the equivalent) will have a washout period of 12 months.
- •Depo-medroxyprogesterone acetate within the previous 24 months (if duration of use was less than 2 consecutive years).
- •Note: Subjects using depo-medroxyprogesterone acetate for a duration of use greater than 2 consecutive years will be excluded.
- •Aromatase inhibitors and/or raloxifene within the previous 24 months.
- •Anticonvulsants (phenytoin, phenobarbital, carbamazepine and valproate), anti-retroviral protease inhibitors, cyclosporine, heparin, warfarin, thiazolidinedione, SGLT-2 inhibitors, tricyclic antidepressants, chronic proton pump inhibitor (PPI) use (> 3 months), or selective serotonin reuptake inhibitors (SSRIs) within the previous 3 months
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