EUCTR2020-000412-30-PL招募中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26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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 14 to 45 years. Female subjects aged between 14 to 17 years (inclusive) will only be included provided that
- •a. Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services, and
- •b. All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.
- •2. Systolic blood pressure < 130 mmHg, diastolic blood pressure < 80 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, or assent if the subject is an adolescent, prior to undergoing any trial-related procedures.
- •5. Willing to use trial contraception for thirteen 28-day cycles (LF111 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 LF111 arm only).
- •2. BMD Z-score below -1.5.
- •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 Erhlos-Danlos syndrome
- •c. Chronic kidney disease stage 3 with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 using the Bedside Schwartz equation for adolescents and 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.
- •6. Use of oral, transdermal, vaginal or intrauterine hormonal contraceptives in the previous month (within the previous 3 months in case of containing estrogen) or use of injectable or 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 past year
- •10. Eating disorders (e.g., anorexia nervosa, bulimia).
- •11. Celiac disease.
- •12. Endocrine disorders (e.g., diabetes, hypothyroidism or hyperthyroidism, hyperparathyroidism, Cushing's disease).
- •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, chronic extensive topical) 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 years).
- •Note: Subjects using depo-medroxyprogesterone acetate for a duration of use greater than 2 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, selective serotonin reuptake inhibitors (SSRIs) within the previous 3 months.
- •16. Conditions that preclud
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