Vaginal bleeding/spotting with conjugated estrogens/bazedoxifene, conjugated estrogens/medroxyprogesterone acetate, and placebo
| Autor: | Paula Abreu, Emma Andrews, Risa Kagan |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Adult
Selective Estrogen Receptor Modulators medicine.medical_specialty Indoles 030209 endocrinology & metabolism Medroxyprogesterone Acetate Placebo Conjugated Estrogens/Medroxyprogesterone Bazedoxifene 03 medical and health sciences 0302 clinical medicine Double-Blind Method Internal medicine medicine Humans Vaginal bleeding Aged Estrogens Conjugated (USP) 030219 obstetrics & reproductive medicine Dose-Response Relationship Drug business.industry Estrogen Replacement Therapy General Medicine Middle Aged Spotting medicine.disease Postmenopause Menopause Endocrinology Female Amenorrhea Uterine Hemorrhage Conjugated Estrogens/Bazedoxifene medicine.symptom business hormones hormone substitutes and hormone antagonists medicine.drug |
| Zdroj: | Postgraduate Medicine. 130:687-693 |
| ISSN: | 1941-9260 0032-5481 |
| DOI: | 10.1080/00325481.2018.1520046 |
| Popis: | In the 1-year phase 3 Selective estrogens, Menopause, And Response to Therapy-5 trial, cumulative amenorrhea rates with conjugated estrogens/bazedoxifene (CE/BZA) were similar to placebo and higher than with conjugated estrogens/medroxyprogesterone acetate (CE/MPA). This post hoc analysis reports bleeding/spotting rates in 4-week intervals (cycles) and 3-month intervals (quarters) with these therapies and the percentage of cases attributable to spotting only.Generally healthy postmenopausal women with menopausal symptoms recorded vaginal bleeding/spotting in daily diaries while receiving CE 0.45 mg/BZA 20 mg, CE 0.625 mg/BZA 20 mg, CE 0.45 mg/MPA 1.5 mg, or placebo.A total of 1596 women in the modified intent-to-treat population contributed data. Incidence of bleeding/spotting was significantly (p 0.001) lower with CE 0.45 mg/BZA 20 mg (0.54‒4.44%), CE 0.625 mg/BZA 20 mg (1.26‒5.02%), and placebo (1.55‒4.82%) compared with CE 0.45 mg/MPA 1.5 mg (8.81‒25.63%) in all 4-week cycles. Each quarter,10% of women taking CE/BZA doses or placebo had bleeding/spotting, significantly (p 0.001) less than the 21-36% with CE 0.45 mg/MPA 1.5 mg. Odds ratio for bleeding/spotting with CE 0.45 mg/BZA 20 mg vs CE 0.45 mg/MPA 1.5 mg was 0.1 in each quarter (95% CI, Q1-Q3: 0.1-0.2; Q4: 0.1-0.3). Across all treatments, most (88-100%) bleeding/spotting cases were spotting only. Mean days of bleeding/spotting were1 per quarter with CE/BZA doses and placebo, which was significantly (p 0.01) less than the 3-5 days per quarter with CE/MPA.Bleeding/spotting with CE/BZA treatment was similar to placebo and significantly less frequent than with CE/MPA treatment. Most cases were spotting only across all treatments. |
| Databáze: | OpenAIRE |
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