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Hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen)

OBJECTIVE: To assess whether the combined oral contraceptive (COC) ethinylestradiol (EE) 20 μg/drospirenone 3 mg taken in a 24/4-day regimen (ie, 4-day hormone-free interval) is more effective than an EE 20 μg/desogestrel (DSG) 150 μg COC taken in a 21/7-day regimen (ie, 7-day hormone-free interval)...

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Autores principales: Bitzer, Johannes, Banal-Silao, Maria Jesusa, Ahrendt, Hans-Joachim, Restrepo, Jaime, Hardtke, Marion, Wissinger-Graefenhahn, Ulrike, Trummer, Dietmar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4445871/
https://www.ncbi.nlm.nih.gov/pubmed/26056491
http://dx.doi.org/10.2147/IJWH.S77942
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author Bitzer, Johannes
Banal-Silao, Maria Jesusa
Ahrendt, Hans-Joachim
Restrepo, Jaime
Hardtke, Marion
Wissinger-Graefenhahn, Ulrike
Trummer, Dietmar
author_facet Bitzer, Johannes
Banal-Silao, Maria Jesusa
Ahrendt, Hans-Joachim
Restrepo, Jaime
Hardtke, Marion
Wissinger-Graefenhahn, Ulrike
Trummer, Dietmar
author_sort Bitzer, Johannes
collection PubMed
description OBJECTIVE: To assess whether the combined oral contraceptive (COC) ethinylestradiol (EE) 20 μg/drospirenone 3 mg taken in a 24/4-day regimen (ie, 4-day hormone-free interval) is more effective than an EE 20 μg/desogestrel (DSG) 150 μg COC taken in a 21/7-day regimen (ie, 7-day hormone-free interval) in reducing hormone withdrawal-associated symptoms (HWAS). METHODS: This double-blind, randomized study (NLM identifier: NCT01076582) was conducted at 34 centers in 12 countries. Otherwise healthy women who experienced ≥2 HWAS of headache, pelvic pain, and/or bloating when using their current COCs in a 21/7-day regimen were recruited. Subjects rated the severity of their HWAS daily on a seven-point Likert scale during a baseline cycle and during four 28-day cycles with EE/drospirenone 24/4 (n=290) or EE/DSG 21/7 (n=304). The primary variable was the mean change from baseline to cycle 4 in the composite HWAS score (sum of scores for all three symptoms) during cycle days 22–28. RESULTS: In the EE/drospirenone 24/4 group, the mean (standard deviation) composite HWAS score during cycle days 22–28 was reduced from 42.2 (24.8) at baseline to 12.8 (13.4) at cycle 4 (change from baseline: −30.3 [22.9]). In the EE/DSG 21/7 group, the corresponding value was reduced from 41.9 (25.8) to 14.3 (13.2) (change from baseline: −27.7 [24.8]), not significantly different versus EE/drospirenone 24/4. Bleeding pattern, treatment response, rescue medication use, compliance, quality of life, and tolerability were similar between treatments. CONCLUSION: Both EE/drospirenone 24/4 and EE/DSG 21/7 reduced the composite HWAS score from baseline to cycle 4 in otherwise healthy women. The differences between treatments were too small to be statistically significant.
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spelling pubmed-44458712015-06-08 Hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen) Bitzer, Johannes Banal-Silao, Maria Jesusa Ahrendt, Hans-Joachim Restrepo, Jaime Hardtke, Marion Wissinger-Graefenhahn, Ulrike Trummer, Dietmar Int J Womens Health Original Research OBJECTIVE: To assess whether the combined oral contraceptive (COC) ethinylestradiol (EE) 20 μg/drospirenone 3 mg taken in a 24/4-day regimen (ie, 4-day hormone-free interval) is more effective than an EE 20 μg/desogestrel (DSG) 150 μg COC taken in a 21/7-day regimen (ie, 7-day hormone-free interval) in reducing hormone withdrawal-associated symptoms (HWAS). METHODS: This double-blind, randomized study (NLM identifier: NCT01076582) was conducted at 34 centers in 12 countries. Otherwise healthy women who experienced ≥2 HWAS of headache, pelvic pain, and/or bloating when using their current COCs in a 21/7-day regimen were recruited. Subjects rated the severity of their HWAS daily on a seven-point Likert scale during a baseline cycle and during four 28-day cycles with EE/drospirenone 24/4 (n=290) or EE/DSG 21/7 (n=304). The primary variable was the mean change from baseline to cycle 4 in the composite HWAS score (sum of scores for all three symptoms) during cycle days 22–28. RESULTS: In the EE/drospirenone 24/4 group, the mean (standard deviation) composite HWAS score during cycle days 22–28 was reduced from 42.2 (24.8) at baseline to 12.8 (13.4) at cycle 4 (change from baseline: −30.3 [22.9]). In the EE/DSG 21/7 group, the corresponding value was reduced from 41.9 (25.8) to 14.3 (13.2) (change from baseline: −27.7 [24.8]), not significantly different versus EE/drospirenone 24/4. Bleeding pattern, treatment response, rescue medication use, compliance, quality of life, and tolerability were similar between treatments. CONCLUSION: Both EE/drospirenone 24/4 and EE/DSG 21/7 reduced the composite HWAS score from baseline to cycle 4 in otherwise healthy women. The differences between treatments were too small to be statistically significant. Dove Medical Press 2015-05-18 /pmc/articles/PMC4445871/ /pubmed/26056491 http://dx.doi.org/10.2147/IJWH.S77942 Text en © 2015 Bitzer et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Original Research
Bitzer, Johannes
Banal-Silao, Maria Jesusa
Ahrendt, Hans-Joachim
Restrepo, Jaime
Hardtke, Marion
Wissinger-Graefenhahn, Ulrike
Trummer, Dietmar
Hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen)
title Hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen)
title_full Hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen)
title_fullStr Hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen)
title_full_unstemmed Hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen)
title_short Hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen)
title_sort hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen)
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4445871/
https://www.ncbi.nlm.nih.gov/pubmed/26056491
http://dx.doi.org/10.2147/IJWH.S77942
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