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16

项与 Nordic Pharma SAS 相关的临床试验

NCT05683041 / RecruitingN/AIIT

Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy

Clinical study on the prevention of intrauterine adhesions after laparoscopic or laparotomic myomectomy.
Myomas are common in women of reproductive age and myomectomy can lead to intra-uterine adhesions, which can be detrimental to fertility. This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions.

开始日期2023-02-22

申办/合作机构

Ghent University Hospital

[+1]

NCT03880435 / Active, not recruitingN/AIIT

The Cost-effectiveness of Anti-adhesion Treatment With HYALOBARRIER® GEL ENDO Versus no Gel Following the Removal by Hysteroscopy of Endometrial Polyps, Fibroids With Uterine Cavity Deformation, Uterine Septa, Intrauterine Adhesions or Retained Products of Conception for Improving Reproductive Outcome in Women Wishing to Become Pregnant: a Multi-centre, Parallel Group, Superiority, Double-blind, Randomized Controlled Trial

To compare the costs and effects of HYALOBARRIER® GEL ENDO versus no HYALOBARRIER® GEL ENDO for increasing the chance of conception leading to live birth measured at 30 weeks after randomization in women wishing to become pregnant after surgical removal of intrauterine pathology (endometrial polyps, fibroids with uterine cavity deformation, uterine septa, IUAs or RPOC after miscarriage) by hysteroscopy as an outpatient or in hospital treatment.

开始日期2019-04-01

申办/合作机构

Ghent University Hospital

[+3]

NCT05082805 / Unknown statusN/A

Therapeutic Strategy Concerning the Drug Management Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis

This is a longitudinal, observational, prospective, multicentre study conducted in France, among a representative sample of rheumatology doctors.
The aim of this study is to describe in real life the therapeutic strategy when faced with a patient with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) who requires initiation of treatment with biotherapy or targeted therapy. The evolution of the disease and the possible therapeutic adaptations will then be followed for 2 years.

开始日期2019-02-25

申办/合作机构

Nordic Pharma SAS

100 项与 Nordic Pharma SAS 相关的临床结果

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0 项与 Nordic Pharma SAS 相关的专利（医药）

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1

项与 Nordic Pharma SAS 相关的文献（医药）

2020-11-01·European Journal of Obstetrics & Gynecology and Reproductive Biology4区 · 医学

Efficacy of mifepristone – Prostaglandin analogue combination in medical termination of pregnancy up to and beyond 7 weeks of amenorrhea: The RYMMa study.

4区 · 医学

Article

作者: Sicot, Marie ; Agostini, Aubert ; Quaranta, Laura Miquel ; Herman-Demars, Hélène ; Zinovieva, Elena ; Frantz, Sandrine

OBJECTIVETo assess, in real-life conditions, the success rate of the protocol mifepristone 600 mg / prostaglandin analogue (PG) in women requesting medical termination of pregnancy (MToP) either up to or beyond 7 weeks of amenorrhea (WA).STUDY DESIGNThe study was performed between 2015 and 2016. This was a non-interventional prospective, multicentre, longitudinal study conducted in France, among a sample of public and/or private centres dealing with MToP. Characteristics of women, term of Mtop, modality of PG used were reported. The primary outcome was success of MToP, defined as complete abortion without surgical procedure.RESULTSA total of 893 pregnant women with less than the legal term of 14 WA were included in this study: 490 (54.9 %) ≤7 WA and 403 (45.1 %) >7 WA comprising 29 > 9 WA. The mean age of women was 28.1 ± 6.8 years and the one of pregnancy was 7.0 WA ± 1.3 WA. The most frequently used PG combined to mifepristone 600 mg was misoprostol 400 μg (57.0 % ≤7 WA and 35.1 % >7 WA) or 800 μg per os (oral or oral transmucosal) (27.5 % ≤7 WA and 40.1 % >7 WA). Vaginal misoprostol (6.4 %, N = 48) and gemeprost (5.2 %, N = 39) were less used. In women ≤7 WA (N = 422) and women >7 WA (N = 354) for whom result of the MToP was collected, success rates were 94.5 % (95 %CI 91.9 %-96.5 %) and 92.4 % (95 %CI 89.1 %-94.9 %), respectively (p = 0.219). In multivariate regression analysis, three factors were significantly associated with a higher risk of MToP failure: increased number of previous pregnancies (OR = 1.233; 95 %CI 1.086-1.401 for one pregnancy), increased number of previous surgical ToPs (OR = 1.563; 95 %CI 1.036-2.359 for one ToP) and increased interval between mifepristone and PG intake (OR = 1.061; 95 %CI 1.012-1.112 for one hour). Term of pregnancy (OR = 1.497; 95 %CI 0.833-2.690 for ≤7 WA vs >7WA), administration route (OR = 1.553; 95 %CI 0.488-4.936 for oral vs oral transmucosal; and OR = 1.216; 95 %CI 0.625-2.366 for vaginal vs oral transmucosal), and dose of misoprostol (OR = 1.000; 95 %CI 0.999-1.001), were not associated with the risk of failure. Overall, tolerance was good.CONCLUSIONThis study showed, in real-life settings, a high rate of success for MToP using mifepristone 600 mg, independent of the pregnancy term and the therapeutic protocol used. MToP was safe and well tolerated however only a small number of women beyond 9 WA have been included.

100 项与 Nordic Pharma SAS 相关的药物交易

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100 项与 Nordic Pharma SAS 相关的转化医学

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