Ultra-low-dose continuous combined estradiol and dydrogesterone in postmenopausal women: A pooled safety and tolerability analysis
Objective: To assess the safety and tolerability of ultra-low dose estradiol and dydrogesterone (E0.5 mg/D2.5 mg) among postmenopausal women. Methods: This pooled analysis of data from three clinical studies assessed the effects of continuous combined ultra-low-dose estradiol and dydrogesterone amon...
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Taylor & Francis Group
2024-12-01
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| Series: | Gynecological Endocrinology |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/09513590.2024.2375577 |
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| author | Tetiana Tatarchuk John C. Stevenson Qi Yu Elke Kahler Marcelo Graziano Custodio Mulan Ren Rossella E. Nappi Viktoriya Karpova Tommaso Simoncini |
| author_facet | Tetiana Tatarchuk John C. Stevenson Qi Yu Elke Kahler Marcelo Graziano Custodio Mulan Ren Rossella E. Nappi Viktoriya Karpova Tommaso Simoncini |
| author_sort | Tetiana Tatarchuk |
| collection | DOAJ |
| description | Objective: To assess the safety and tolerability of ultra-low dose estradiol and dydrogesterone (E0.5 mg/D2.5 mg) among postmenopausal women. Methods: This pooled analysis of data from three clinical studies assessed the effects of continuous combined ultra-low-dose estradiol and dydrogesterone among postmenopausal women. Participants received E0.5 mg/D2.5 mg or placebo for 13 weeks (double-blind, randomized, European study), E0.5 mg/D2.5 mg or placebo for 12 weeks (double-blind, randomized, Chinese study), or E0.5 mg/D2.5 mg for 52 weeks (open-label, European study). Safety outcomes included treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), treatment discontinuation due to a TEAE, and adverse events of special interest (AESIs). Results: Overall, 1027 women were included in the pooled analysis (E0.5 mg/D2.5 mg, n = 736; placebo, n = 291). Mean treatment exposure was 288.9 days in the E0.5 mg/D2.5 mg group and 86.6 days in the placebo group. The proportion of women experiencing ≥1 TEAE was similar in the E0.5 mg/D2.5 mg and placebo groups (50.1% vs 49.5%, respectively). TESAEs occurred in 12 (1.6%) women receiving E0.5 mg/D2.5 mg and 9 (3.1%) women receiving placebo. Discontinuation of study treatment was infrequent in both groups (E0.5 mg/D2.5 mg: 1.5%; placebo: 2.4%). The occurrence of breast pain was more common in the E0.5 mg/D2.5 mg group than in the placebo group (2.0% vs 0.3%) as was uterine hemorrhage (6.5% vs 2.4%). The incidence of acne, hypertrichoses and weight increased was similar between groups. Conclusions: Across three studies, ultra-low-dose estradiol plus dydrogesterone was well tolerated among postmenopausal women, with no increase in TEAEs or TESAEs compared with placebo. |
| format | Article |
| id | doaj-art-2a693e7feb49414b83fe22b7a3c445aa |
| institution | DOAJ |
| issn | 0951-3590 1473-0766 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Gynecological Endocrinology |
| spelling | doaj-art-2a693e7feb49414b83fe22b7a3c445aa2025-08-20T02:39:22ZengTaylor & Francis GroupGynecological Endocrinology0951-35901473-07662024-12-0140110.1080/09513590.2024.2375577Ultra-low-dose continuous combined estradiol and dydrogesterone in postmenopausal women: A pooled safety and tolerability analysisTetiana Tatarchuk0John C. Stevenson1Qi Yu2Elke Kahler3Marcelo Graziano Custodio4Mulan Ren5Rossella E. Nappi6Viktoriya Karpova7Tommaso Simoncini8Department of Endocrine Gynaecology, National Institute of Pediatrics, Obstetrics and Gynecology of National Academy of Medical Science of Ukraine, Kyiv, UkraineNational Heart and Lung Institute, Royal Brompton Hospital and Imperial College London, London, UKGynecological Endocrinology and Reproductive Center, Peking Union Medical College Hospital, Beijing, ChinaGlobal Biometrics, Established Pharmaceuticals Division, Abbott Laboratories GmbH, Hannover, GermanGlobal Innovation and Development, Established Pharmaceuticals Division, Abbott Products Operations AG, Allschwil, SwitzerlandDepartment of Obstetrics and Gynecology, Zhongda Hospital, Southeast University, Nanjing, ChinaDepartment of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, ItalyEstablished Pharmaceuticals Division, Abbott Ukraine LLC, Kyiv, UkraineDivision of Obstetrics and Gynecology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, ItalyObjective: To assess the safety and tolerability of ultra-low dose estradiol and dydrogesterone (E0.5 mg/D2.5 mg) among postmenopausal women. Methods: This pooled analysis of data from three clinical studies assessed the effects of continuous combined ultra-low-dose estradiol and dydrogesterone among postmenopausal women. Participants received E0.5 mg/D2.5 mg or placebo for 13 weeks (double-blind, randomized, European study), E0.5 mg/D2.5 mg or placebo for 12 weeks (double-blind, randomized, Chinese study), or E0.5 mg/D2.5 mg for 52 weeks (open-label, European study). Safety outcomes included treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), treatment discontinuation due to a TEAE, and adverse events of special interest (AESIs). Results: Overall, 1027 women were included in the pooled analysis (E0.5 mg/D2.5 mg, n = 736; placebo, n = 291). Mean treatment exposure was 288.9 days in the E0.5 mg/D2.5 mg group and 86.6 days in the placebo group. The proportion of women experiencing ≥1 TEAE was similar in the E0.5 mg/D2.5 mg and placebo groups (50.1% vs 49.5%, respectively). TESAEs occurred in 12 (1.6%) women receiving E0.5 mg/D2.5 mg and 9 (3.1%) women receiving placebo. Discontinuation of study treatment was infrequent in both groups (E0.5 mg/D2.5 mg: 1.5%; placebo: 2.4%). The occurrence of breast pain was more common in the E0.5 mg/D2.5 mg group than in the placebo group (2.0% vs 0.3%) as was uterine hemorrhage (6.5% vs 2.4%). The incidence of acne, hypertrichoses and weight increased was similar between groups. Conclusions: Across three studies, ultra-low-dose estradiol plus dydrogesterone was well tolerated among postmenopausal women, with no increase in TEAEs or TESAEs compared with placebo.https://www.tandfonline.com/doi/10.1080/09513590.2024.2375577Ultra-low dose estradioldydrogesteronepostmenopausal womensafetytolerability |
| spellingShingle | Tetiana Tatarchuk John C. Stevenson Qi Yu Elke Kahler Marcelo Graziano Custodio Mulan Ren Rossella E. Nappi Viktoriya Karpova Tommaso Simoncini Ultra-low-dose continuous combined estradiol and dydrogesterone in postmenopausal women: A pooled safety and tolerability analysis Gynecological Endocrinology Ultra-low dose estradiol dydrogesterone postmenopausal women safety tolerability |
| title | Ultra-low-dose continuous combined estradiol and dydrogesterone in postmenopausal women: A pooled safety and tolerability analysis |
| title_full | Ultra-low-dose continuous combined estradiol and dydrogesterone in postmenopausal women: A pooled safety and tolerability analysis |
| title_fullStr | Ultra-low-dose continuous combined estradiol and dydrogesterone in postmenopausal women: A pooled safety and tolerability analysis |
| title_full_unstemmed | Ultra-low-dose continuous combined estradiol and dydrogesterone in postmenopausal women: A pooled safety and tolerability analysis |
| title_short | Ultra-low-dose continuous combined estradiol and dydrogesterone in postmenopausal women: A pooled safety and tolerability analysis |
| title_sort | ultra low dose continuous combined estradiol and dydrogesterone in postmenopausal women a pooled safety and tolerability analysis |
| topic | Ultra-low dose estradiol dydrogesterone postmenopausal women safety tolerability |
| url | https://www.tandfonline.com/doi/10.1080/09513590.2024.2375577 |
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