Sissi Valentina Beinert, Frauke Kleinsorge, Julia Worm, Katharina Victoria Tropschuh, Vanadin Seifert-Klauss
{"title":"孕酮对绝经后妇女血管运动症状的影响 (PROGEST) - 一项前瞻性多中心随机双盲安慰剂对照试验 (RDPCT)。","authors":"Sissi Valentina Beinert, Frauke Kleinsorge, Julia Worm, Katharina Victoria Tropschuh, Vanadin Seifert-Klauss","doi":"10.1055/a-2322-0967","DOIUrl":null,"url":null,"abstract":"<p><p><b>Introduction</b> Monotherapy with progesterone for treatment of vasomotor symptoms (VMS) was more effective than placebo treatment of postmenopausal healthy women in a Canadian trial. The PROGEST-trial was initiated to fulfill FDA-approval criteria for the indication of treatment of postmenopausal VMS. <b>Methods</b> This prospective randomized, double-blind placebo-controlled clinical trial studied three doses of oral micronized progesterone (200 mg, 300 mg, 400 mg) and placebo for 12 weeks. Postmenopausal women with moderate to severe VMS (> 50 per week) were screened for one week for VMS frequency, then randomized to 200, 300 or 400 mg progesterone daily or placebo for a double-blinded trial of 12 weeks duration. <b>Results</b> 74 women were recruited in 12 study centers. 44 terminated the study as per protocol (PP). Moderate to severe hot flushes decreased by 7.4/d in the placebo arm, 7.7 VMS/d with 200 mg/d progesterone (P4), 8.3 VMS/d on 300 mg/d and 9.0 VMS/d on 400 mg/d P4, respectively by week 12. 32 treatment emergent adverse events were documented in 18 participants, mostly minor AEs. The only SAE was a syncope requiring hospitalization on the day after treatment initiation, leading to discontinuation of the drug. <b>Discussion</b> Baseline VMS frequency was much higher in the German than in the Canadian study and the course of the placebo group had a markedly stronger decrease in VMS-frequency during the PROGEST study (-7.4/d) than in the Canadian trial (-1.4/d). Trial populations differed by age, BMI, the number of women with natural menopause, and comorbidities, mainly hypertension. <b>Conclusion</b> Premature discontinuation of the trial due to insufficient subject accrual rate led to only 55 randomized participants for analysis, therefore the study results lack statistical power. Still, a slight dose-dependent improvement in VMS was seen for all doses, while AE frequency did not increase with progesterone dose.</p>","PeriodicalId":12481,"journal":{"name":"Geburtshilfe Und Frauenheilkunde","volume":"84 10","pages":"969-978"},"PeriodicalIF":2.4000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11444746/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effects of Progesterone on Vasomotor Symptoms in Postmenopausal Women (PROGEST) - a Prospective Multi-Center Randomized Double-Blind Placebo-Controlled Trial (RDPCT).\",\"authors\":\"Sissi Valentina Beinert, Frauke Kleinsorge, Julia Worm, Katharina Victoria Tropschuh, Vanadin Seifert-Klauss\",\"doi\":\"10.1055/a-2322-0967\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Introduction</b> Monotherapy with progesterone for treatment of vasomotor symptoms (VMS) was more effective than placebo treatment of postmenopausal healthy women in a Canadian trial. The PROGEST-trial was initiated to fulfill FDA-approval criteria for the indication of treatment of postmenopausal VMS. <b>Methods</b> This prospective randomized, double-blind placebo-controlled clinical trial studied three doses of oral micronized progesterone (200 mg, 300 mg, 400 mg) and placebo for 12 weeks. Postmenopausal women with moderate to severe VMS (> 50 per week) were screened for one week for VMS frequency, then randomized to 200, 300 or 400 mg progesterone daily or placebo for a double-blinded trial of 12 weeks duration. <b>Results</b> 74 women were recruited in 12 study centers. 44 terminated the study as per protocol (PP). Moderate to severe hot flushes decreased by 7.4/d in the placebo arm, 7.7 VMS/d with 200 mg/d progesterone (P4), 8.3 VMS/d on 300 mg/d and 9.0 VMS/d on 400 mg/d P4, respectively by week 12. 32 treatment emergent adverse events were documented in 18 participants, mostly minor AEs. The only SAE was a syncope requiring hospitalization on the day after treatment initiation, leading to discontinuation of the drug. <b>Discussion</b> Baseline VMS frequency was much higher in the German than in the Canadian study and the course of the placebo group had a markedly stronger decrease in VMS-frequency during the PROGEST study (-7.4/d) than in the Canadian trial (-1.4/d). Trial populations differed by age, BMI, the number of women with natural menopause, and comorbidities, mainly hypertension. <b>Conclusion</b> Premature discontinuation of the trial due to insufficient subject accrual rate led to only 55 randomized participants for analysis, therefore the study results lack statistical power. Still, a slight dose-dependent improvement in VMS was seen for all doses, while AE frequency did not increase with progesterone dose.</p>\",\"PeriodicalId\":12481,\"journal\":{\"name\":\"Geburtshilfe Und Frauenheilkunde\",\"volume\":\"84 10\",\"pages\":\"969-978\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2024-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11444746/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Geburtshilfe Und Frauenheilkunde\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1055/a-2322-0967\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Geburtshilfe Und Frauenheilkunde","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1055/a-2322-0967","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
Effects of Progesterone on Vasomotor Symptoms in Postmenopausal Women (PROGEST) - a Prospective Multi-Center Randomized Double-Blind Placebo-Controlled Trial (RDPCT).
Introduction Monotherapy with progesterone for treatment of vasomotor symptoms (VMS) was more effective than placebo treatment of postmenopausal healthy women in a Canadian trial. The PROGEST-trial was initiated to fulfill FDA-approval criteria for the indication of treatment of postmenopausal VMS. Methods This prospective randomized, double-blind placebo-controlled clinical trial studied three doses of oral micronized progesterone (200 mg, 300 mg, 400 mg) and placebo for 12 weeks. Postmenopausal women with moderate to severe VMS (> 50 per week) were screened for one week for VMS frequency, then randomized to 200, 300 or 400 mg progesterone daily or placebo for a double-blinded trial of 12 weeks duration. Results 74 women were recruited in 12 study centers. 44 terminated the study as per protocol (PP). Moderate to severe hot flushes decreased by 7.4/d in the placebo arm, 7.7 VMS/d with 200 mg/d progesterone (P4), 8.3 VMS/d on 300 mg/d and 9.0 VMS/d on 400 mg/d P4, respectively by week 12. 32 treatment emergent adverse events were documented in 18 participants, mostly minor AEs. The only SAE was a syncope requiring hospitalization on the day after treatment initiation, leading to discontinuation of the drug. Discussion Baseline VMS frequency was much higher in the German than in the Canadian study and the course of the placebo group had a markedly stronger decrease in VMS-frequency during the PROGEST study (-7.4/d) than in the Canadian trial (-1.4/d). Trial populations differed by age, BMI, the number of women with natural menopause, and comorbidities, mainly hypertension. Conclusion Premature discontinuation of the trial due to insufficient subject accrual rate led to only 55 randomized participants for analysis, therefore the study results lack statistical power. Still, a slight dose-dependent improvement in VMS was seen for all doses, while AE frequency did not increase with progesterone dose.
期刊介绍:
Geburtshilfe und Frauenheilkunde (GebFra) addresses the whole field of obstetrics and gynecology and is concerned with research as much as with clinical practice. In its scientific section, it publishes original articles, reviews and case reports in all fields of the discipline, namely
gynecological oncology, including oncology of the breast
obstetrics and perinatal medicine,
reproductive medicine,
and urogynecology.
GebFra invites the submission of original articles and review articles.
In addition, the journal publishes guidelines, statements and recommendations in cooperation with the DGGG, SGGG, OEGGG and the Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF, Association of Scientific Medical Societies, www.awmf.org). Apart from the scientific section, Geburtshilfe und Frauenheilkunde has a news and views section that also includes discussions, book reviews and professional information.
Letters to the editors are welcome. If a letter discusses an article that has been published in our journal, the corresponding author of the article will be informed and invited to comment on the letter. The comment will be published along with the letter.