Document Detail


Continuous combination oral contraceptive pills to eliminate withdrawal bleeding: a randomized trial.
MedLine Citation:
PMID:  12681866     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To compare bleeding profiles of a traditional 28-day oral contraceptive pill cycle with continuous administration. METHODS: After a 28-day run-in cycle, women were randomized to either 28-day cycles (21 active pills and a pill-free week) or continuous use of the same 20 microg ethinyl estradiol/100 microg levonorgestrel formulation for 12 study cycles (336 days). The number of bleeding and spotting days were measured by daily diary. A subset underwent cycle 1 (n = 16), and nine (n = 14) pelvic ultrasound and endometrial histology sampling. Blood pressure, weight, hemoglobin, and adverse events were measured at revisit. The sample size with 80% power to detect a 67% reduction in bleeding days required 27 subjects in each arm. RESULTS: Of the 79 subjects randomized, 28 (70%) of the 28-day cycle and 32 (82%) of the continuous-use subjects completed the entire study (P =.6). With continuous use, 49%, 68%, and 88% of women reported no bleeding during cycles 2, 6, and 12, respectively. Amenorrhea or infrequent bleeding was present in 68% of continuous users during cycles 1-3 and increased to 88% during cycles 10-12. Spotting during cycle days 1-21 increased initially with continuous use but reduced over time, and by 9 months was less than the spotting reported by cyclic users. Adverse events, blood pressure, weight, and hemoglobin findings were similar between groups. CONCLUSION: Extension of the 28-day oral contraceptive cycle to continuous use with a low-estrogen dose combination oral birth control pill resulted in significantly fewer bleeding days.
Authors:
Leslie Miller; James P Hughes
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Obstetrics and gynecology     Volume:  101     ISSN:  0029-7844     ISO Abbreviation:  Obstet Gynecol     Publication Date:  2003 Apr 
Date Detail:
Created Date:  2003-04-08     Completed Date:  2003-04-24     Revised Date:  2009-10-26    
Medline Journal Info:
Nlm Unique ID:  0401101     Medline TA:  Obstet Gynecol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  653-61     Citation Subset:  AIM; IM    
Affiliation:
Departments of Obstetrics & Gynecology, University of Washington, Seattle, Washington, USA. lmiller@u.washington.edu
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MeSH Terms
Descriptor/Qualifier:
Adult
Contraceptives, Oral, Combined / administration & dosage*
Drug Administration Schedule
Endometrium / pathology,  ultrasonography
Ethinyl Estradiol / administration & dosage*
Female
Humans
Levonorgestrel / administration & dosage*
Menstrual Cycle / drug effects*
Treatment Outcome
Uterine Hemorrhage / prevention & control*
Chemical
Reg. No./Substance:
0/Contraceptives, Oral, Combined; 57-63-6/Ethinyl Estradiol; 797-63-7/Levonorgestrel
Comments/Corrections
Comment In:
J Fam Pract. 2003 Aug;52(8):601-2   [PMID:  12899813 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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