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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series involving male to female transitioned (transsexual) patients, a 35-year-old man developed cutaneous scleroderma following treatment with norethisterone/mestranol [Norinyl-1R]; a 49-year-old man developed cutaneous scleroderma/ rheumatoid arthritis overlap syndrome following treatment with conjugated estrogen [Premarin] and ethinylestradiol/gestodene [Femodene] and a 43-year-old man developed cutaneous scleroderma/myositis overlap syndrome (one patient) following treatment with conjugated estradiol valerate and triptorelin [Decapeptyl; dosages and routes not stated].
Case 1: The 35-year-old man had undergone male to female transsexual transition five years prior. At the beginning of the transition, he had started hormonal therapy with norethisterone/mestranol....
- Campochiaro C, et al. Development of systemic sclerosis in transgender females: A case series and review of the literature. Clinical and Experimental Rheumatology 36 (Suppl. 113): S50-S52, No. 113, Jan 2018. Available from: URL: http://www.clinexprheumatol.org/article.asp?a=12276 - United Kingdom