Effects of immunomodulatory therapy on gonadal function in women with autoimmune premature ovarian insufficiency

Karolinska University Hospital0 个研究点开始时间: 2019年2月26日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1. Autoimmune premature ovarian insufficiency defined as presence of autoantibodies against 21-OH, SCC, 17-OH and/or NALP5 or other relevant autoantibodies
•2. 18-35 years of age
•3. body mass index 19-30
•4. Willingness to comply with effective non-hormonal contraceptive methods upto 12 months after the last infusion
•5. Ability to provide informed consent
•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 15
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Documented hypersensitivity or intolerance to rituximab
•2. Active, severe infection
•3. Severe immunosuppression
•4. Severe cardiac disease
•6. Benign tumours of the hypothalamus, pituitary, or ovary; ovarian enlargement or ovarian cyst
•7. Vaginal bleeding of unknown aetiology
•8. Hormone replacement therapy (HRT) within four weeks prior study entry.
•9. Pregnant or lactating women, s-HCG/u-HCG
•10. Concurrent treatment with other immunosuppressive drugs
•11. Vaccination within 4 weeks of infusion of study medication
•12. Severe psychiatric disorder
•13. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with Rituximab.

发起方

Karolinska University Hospital