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A multicenter, double-blind, randomized trial on the bleeding profile of a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg.
| Content Provider | Europe PMC |
|---|---|
| Author | Palacios, Santiago Colli, Enrico Regidor, Pedro-Antonio |
| Abstract | PurposeA typical compliance problem in the use of traditional progestin-only pills is the irregular bleeding pattern and the strict daily intake. Desogestrel 75 mg has a 12-h missed-pill window; however, its poor cycle control limits a more common use.MethodsA drospirenone (DRSP)-only pill was developed to improve the bleeding profile.SettingA phase III study in healthy women aged 18–45 years was performed to compare the bleeding profile and safety of a DRSP-only pill in a regime of 24 days of 4 mg of DRSP tablets followed by 4 days of placebo versus desogestrel 0.075 mg per day continuously over nine cycles.PopulationA total of 858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed.Main outcome measuresThe primary end point was the proportion of women with unscheduled bleeding/spotting in each cycle from cycles 2 to 9 and cumulative in cycles 2–4 and cycles 7–9.ResultsIn each cycle, up to cycle 7, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, Chi-square test).ConclusionsThis report describes the improvement in bleeding profile of women using the new DRSP-only oral contraceptive in comparison to DSG, providing a better quality of live and adherence to the contraceptive method.EudraCT Registration Number: 2011-002396-42.Electronic supplementary materialThe online version of this article (10.1007/s00404-019-05340-4) contains supplementary material, which is available to authorized users. |
| Related Links | https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC7174261&blobtype=pdf |
| ISSN | 09320067 |
| Journal | Archives of Gynecology and Obstetrics [Arch Gynecol Obstet] |
| Volume Number | 300 |
| DOI | 10.1007/s00404-019-05340-4 |
| PubMed Central reference number | PMC7174261 |
| Issue Number | 6 |
| PubMed reference number | 31728664 |
| e-ISSN | 14320711 |
| Language | English |
| Publisher | Springer Berlin Heidelberg |
| Publisher Date | 2019-11-14 |
| Publisher Place | Berlin/Heidelberg |
| Access Restriction | Open |
| Rights License | Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. © The Author(s) 2019, corrected publication, 2020 |
| Subject Keyword | Drospirenone only pill Cycle control Bleeding |
| Content Type | Text |
| Resource Type | Article |
| Subject | Obstetrics and Gynecology |
