Fervent Pharmaceuticals ngumumake dina iki yen wis miwiti sinau klinis virtual kanggo ngevaluasi efektifitas produk novel kasebut kanggo ngobati gejala kelip-kelip panas sing moderat nganti abot, kringet wengi lan tangi wengi amarga kelip-kelip panas. Produk iki dimaksudaké kanggo kasedhiya, yen disetujoni dening FDA, kanggo patients tanpa perlu kanggo resep. Panaliten remot jinis iki minangka salah sawijining jinis pisanan sing diwenehake dening FDA. Patients ing sinau bakal melu mbatalake saka comfort saka omah-omahé dhewe, ngendi kabeh produk diselidiki bakal dikirim, lan saka ngendi kabeh koleksi data bakal kelakon.
M2S Hot Flash Study dirancang kanggo nyakup wanita peri-menopausal lan post-menopause sing umure luwih saka 45 taun sing ngalami paling ora 7 nganti 8 panas sedheng nganti abot saben dina. Wanita sing ketemu kritéria kasebut bisa nglamar ing www.m2shotflashstudy.com kanggo dianggep minangka partisipasi ing panliten iki.
"Aku bungah babagan produk sing diteliti lan kemungkinan sing bisa ditindakake kanggo nambah kualitas urip pasien kasebut. Salajengipun, gadhah desain sinau sing ndadekke penak kanggo partisipasi langsung menyang omah-omahé pasien ngidini luwih akeh pasien sing bisa melu, lan nindakake ing jadwal, "ujare George Royster, Pendhiri / CEO Fervent Pharmaceuticals. "Kita bungah banget kanggo sinau iki lan ningkatake urip wanita liwat terapi anyar kanggo gejala menopause."
Uji coba telung minggu kasedhiya kanggo peserta sing layak ing saindenging negoro. Peserta bakal dijaluk nglacak gejala vasomotor kanthi online sajrone uji coba lan ngrampungake survey ing kesimpulan panaliten. Produk investigasi sing bakal disedhiyakake kalebu formulasi oral dosis, non-hormonal, non-herbal, non-antidepresan saka senyawa sing wis dikenal mekanisme tumindak, wis digunakake digunakake kanggo indikasi sing beda, lan duwe sejarah dawa nggunakake aman. . Materi uji coba uga bakal kalebu materi pelatihan kanggo ngajari para peserta babagan cara nggunakake piranti lunak laporan pasien sinau.
Fervent Pharmaceuticals minangka perusahaan pangembangan obat tahap klinis sing diadegake ing North Carolina ing 2011. Fokus kanggo ningkatake kualitas urip wanita kanthi ngembangake terapi sing ngarahake kabutuhan sing ora bisa ditindakake ing kesehatan wanita.
APA sing kudu dijupuk saka ARTIKEL INI:
- The investigational products to be provided include an orally dosed, non-hormonal, non-herbal, non-antidepressant formulation of a compound that has known mechanisms of action, is already widely used for a different indication, and has a long history of safe use.
- The M2S Hot Flash Study is designed to include peri-menopausal and post-menopausal women over the age of 45 who experience at least 7 to 8 moderate to severe hot flashes per day.
- Fervent Pharmaceuticals announced today that it has commenced its virtual clinical study to evaluate the effectiveness of its novel product for the treatment of the symptoms of moderate to severe hot flashes, night sweats and nighttime awakenings due to hot flashes.
