EUCTR2021-000452-19-HU进行中（未招募）1 期
A long-term follow-up study to assess bone mineral density in subjects with uterine fibroids completing the Phase 3 studies of linzagolix, PRIMROSE 1 or PRIMROSE 2 - PRIMROSE 3
ObsEva S.A.0 个研究点目标入组 400 人开始时间: 2021年3月24日最近更新:
适应症
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
- 400
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. The subject must provide written informed consent.
- •2. The subject completed at least 20 weeks of treatment in PRIMROSE 1 or PRIMROSE 2 and underwent an end-of-treatment DXA scan
- •3. The subject is enrolled within 24 months from the last treatment administration in PRIMROSE 1 or PRIMROSE 2.
- •4. The subject is willing and able to comply with the requirements of the study protocol for the duration of the PRIMROSE 3 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 400
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The subject is pregnant.
- •2. The subject can not have her scans done on the same DXA machine type as used for the end-of-treatment DXA scan in PRIMROSE 1 or PRIMROSE 2
- •3. The subject is currently taking part in a clinical trial or has been administered any experimental drug since completion of PRIMROSE 1 or PRIMROSE 2.
- •4. The subject has any condition that, in the opinion of the Investigator, constitutes a risk or a contraindication to the participation of the subject in this study, or that could interfere with the study objectives, conduct or assessments.
研究者
相似试验
进行中（未招募）
1 期
ong-term bone mineral density follow-up in subjects completing PRIMROSE 1 or PRIMROSE 2Treatment of heavy menstrual bleeding associated with uterine fibroids.MedDRA version: 21.1Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864EUCTR2021-000452-19-BGObsEva S.A.400
进行中（未招募）
1 期
ong-term bone mineral density follow-up in subjects completing PRIMROSE 1 or PRIMROSE 2Treatment of heavy menstrual bleeding associated with uterine fibroids.MedDRA version: 21.1Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864EUCTR2021-000452-19-PLObsEva S.A.400
进行中（未招募）
1 期
ong-term bone mineral density follow-up in subjects completing PRIMROSE 1 or PRIMROSE 2Treatment of heavy menstrual bleeding associated with uterine fibroids.MedDRA version: 21.1Level: LLTClassification code 10046784Term: Uterine fibroidsSystem Organ Class: 100000004864EUCTR2021-000452-19-LVKissei Pharmaceutical Co., Ltd.147
进行中（未招募）
1 期
ong-term bone mineral density follow-up in subjects completing PRIMROSE 1 or PRIMROSE 2EUCTR2021-000452-19-ROObsEva S.A.400
已完成
不适用
ong-term observation on adult bone mineral density and lifestyle-related diseases prevention with daily lemon intake in Osakikamijima Town, Hiroshima prefectureJPRN-UMIN000025818SAPPORO HOLDINGS Ltd.170