CTIS2022-502023-21-00进行中（未招募）1 期
A multicentre, single arm trial on contraceptive efficacy, safety and tolerability of LVDS (Levonorgestrel Vaginal Delivery System) during 13 cycles. - LR-301
Chemo Research S.L.0 个研究点目标入组 1,046 人开始时间: 2023年3月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,046
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
- 年龄范围
- 0 至 64（—）
入选标准
- •[Visit 1a:] Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women., [Visit 1a:] Be willing to state that, to her best knowledge, her male sexual partner/partners has/have not had a vasectomy or been previously diagnosed as infertile (not applicable to adolescents)., [Visit 1a:] Agree not to participate in any other clinical trials during the course of this trial (participation in a non-interventional study is allowed)., [Visit 1a:] Only for female subjects between the ages of 15 and 17 (inclusive) provided that: a. Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services, b. All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed. c. All special radiation protection approval requirements have been confirmed by corresponding official approvals and the sponsor has authorised the recruitment of underage participants in writing to the trial site. (Adolescents will not be included in Czech Republic and Germany), [Visit 1a:] Women who either a. have never used hormonal contraceptives before consent/assent (naïve users), or b. have used hormonal contraceptives in the past, but have had a hormonal contraceptive-free period before consent/assent and a full menstrual cycle during the drug-free period (previous users) or c. directly switch from another hormonal contraceptive (switchers)., [Visit 1a:] Only for subjects who were not pregnant and did not use hormonal contraception during the last 6 months before consent/assent: Regular cycles (i.e. cycle length between 24 and 35 days) during the last 6 months., [Visit 1a:] Only for women who were pregnant within the last 6 months before consent/assent: At least 3 complete menstrual cycles after pregnancy. Breastfeeding women can be included 4 weeks after delivery irrespective of menstrual cycles post-delivery., [Visit 1a:] Systolic blood pressure = 140 mm Hg and diastolic blood pressure = 90 mm Hg, subjects with controlled hypertension are allowed., [Visit 1a:] A written informed consent/assent is available, prior to undergoing any trial-related procedure., [Visit 1a:] Willing to use trial contraception for thirteen 28-day cycles., [Visit 1a:] Be willing to have intercourse in each cycle of the trial without the need to use back-up contraceptive (not applicable to adolescents).
排除标准
- •[Visit 1a / Visit 1b:] Pregnancy or wish of pregnancy., [Visit 1a:] Severe COVID-19 disease or less than 3 months after hospitalization due to a COVID-19 disease., [Visit 1a:] Known HIV infection., [Visit 1a:] Known current or chronic hepatitis B or C., [Visit 1a / Visit 1b:] Prohibited previous medication/therapy (as given in the protocol)., [Visit 1a / Visit 1b:] Dependence on prohibited co-medication/- therapy (as given in the protocol)., [Visit 1a / Visit 1b:] Progestin-releasing intra-uterine device (IUD) or contraceptive implant received or in place within the last 2 months., [Visit 1a:] Planned regular concomitant use of barrier contraceptive methods, spermicides, IUDs or other contraceptive measures., [Visit 1a:] Subject is a member of the investigator’s or sponsor’s staff or a relative or family member thereof., [Visit 1a:] Is in custody or submitted to an institution by a court order., [Visit 1a / Visit 1b:] Any condition or any disease that, in the opinion of the investigator, may jeopardize protocol compliance or the scientific integrity of the trial., [Visit 1a:] Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary., [Visit 1a: Additional exclusion criteria for the BMD subgroup (adolescents) (except for Czech Republic and Germany):] History of 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., [Visit 1a: Additional exclusion criteria for the BMD subgroup (adolescents) (except for Czech Republic and Germany):] Known medical conditions associated with low bone mass: a. Metabolic bone disease such as osteogenesis imperfecta, Paget’s disease of the bone, osteomalacia/rickets b. Rheumatoid arthritis c. Collagen vascular diseases such as Marfan’s syndrome and Erhlos-Danlos syndrome d. Chronic kidney disease e. Hyperparathyroidism and abnormal bone mineral metabolism (hypocalcemia/ hypercalcemia, hypophosphatemia/ hyperphosphatemia, hypomagnesemia)., [Visit 1a: Additional exclusion criteria for the BMD subgroup (adolescents) (except for Czech Republic and Germany):] Current or ever use of medications or supplements known to increase BMD including bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab, calcitonin, fluoride and strontium., [Visit 1a: Additional exclusion criteria for the BMD subgroup (adolescents) (except for Czech Republic and Germany):] Treatment with medications that are known to decrease bone mass: a. Glucocorticoids (oral, intravenous, chronic inhaled, chronic extensive topical) within the previous 3 months. Oral/intravenous glucocorticoids (prednisone = 2.5 mg daily for = 3 months, or the equivalent) within the last 12 months. b. Depo-medroxyprogesterone acetate within the previous 24 months. Depo-medroxyprogesterone acetate for a duration of use greater than 2 years ever in life. c. Aromatase inhibitors and/or raloxifene within the previous 24 months. d. Heparin, warfarin, thiazolidinedione, SGLT-2 inhibitors, tricyclic antidepressants, chronic proton pump inhibitor (PPI) use, selective serotonin reuptake inhibitors (SSRIs) within the previous 3 months., [Visit 1a: Additional exclusion criteria for the BMD subgroup (adolescents) (except for Czech Republic and Germany):] Conditions that preclude BMD measurement i.e. lumbar spine/bilateral hip surgery with hardware in place, abdominal clips, umbilical ring (not
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