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Changes in coagulation and anticoagulation in women taking low-dose triphasic oral contraceptives: a controlled comparative 12-month clinical trial.
Am J Obstet Gynecol. 1992 Nov; 167(5):1255-61.AJ

Abstract

OBJECTIVE

The effects of two triphasic oral contraceptives on coagulation and anticoagulation factors were compared in a 12-month open-label study.

STUDY DESIGN

Fifty-two women (mean age 26 years) were enrolled in and completed the study; 20 had been randomly assigned to receive levonorgestrel plus ethinyl estradiol, 24 had been randomly assigned to receive norethindrone plus ethinyl estradiol, and eight surgically sterile women acted as untreated controls. Coagulation and anticoagulation factors were measured at baseline and during the sixth and twelfth months.

RESULTS

Both oral contraceptives produced significant decreases from baseline in prothrombin time and partial thromboplastin time; there were also significant changes in laboratory control times. Factor XII was significantly increased in both oral contraceptive groups after 6 and 12 months. Fibrinogen antigen was significantly increased for norethindrone plus ethinyl estradiol after 6 and 12 months and for levonorgestrel plus ethinyl estradiol after 12 months. Platelet counts were unchanged. There was a significant increase in antithrombin III activity with norethindrone plus ethinyl estradiol at 12 months. Antithrombin III antigen was unchanged with the oral contraceptives; however, significant increases existed for alpha 1-antitrypsin antigen and plasminogen antigen and activity after 6 and 12 months and for alpha 2-macroglobulin antigen after 12 months for both oral contraceptives. alpha 2-Antiplasmin antigen was significantly increased for norethindrone plus ethinyl estradiol at the 12-month evaluation. There were no significant differences between the oral contraceptives for any coagulation or anticoagulation factor, and mean values generally remained within reference ranges.

CONCLUSIONS

Levonorgestrel plus ethinyl estradiol and norethindrone plus ethinyl estradiol had equivalent, minimal effects on hemostasis, and changes in coagulation factors appeared to be balanced by changes in anticoagulation factors.

Authors+Show Affiliations

Center for Climacteric Studies, Inc., Gainesville, FL.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

1442974

Citation

Notelovitz, M, et al. "Changes in Coagulation and Anticoagulation in Women Taking Low-dose Triphasic Oral Contraceptives: a Controlled Comparative 12-month Clinical Trial." American Journal of Obstetrics and Gynecology, vol. 167, no. 5, 1992, pp. 1255-61.
Notelovitz M, Kitchens CS, Khan FY. Changes in coagulation and anticoagulation in women taking low-dose triphasic oral contraceptives: a controlled comparative 12-month clinical trial. Am J Obstet Gynecol. 1992;167(5):1255-61.
Notelovitz, M., Kitchens, C. S., & Khan, F. Y. (1992). Changes in coagulation and anticoagulation in women taking low-dose triphasic oral contraceptives: a controlled comparative 12-month clinical trial. American Journal of Obstetrics and Gynecology, 167(5), 1255-61.
Notelovitz M, Kitchens CS, Khan FY. Changes in Coagulation and Anticoagulation in Women Taking Low-dose Triphasic Oral Contraceptives: a Controlled Comparative 12-month Clinical Trial. Am J Obstet Gynecol. 1992;167(5):1255-61. PubMed PMID: 1442974.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Changes in coagulation and anticoagulation in women taking low-dose triphasic oral contraceptives: a controlled comparative 12-month clinical trial. AU - Notelovitz,M, AU - Kitchens,C S, AU - Khan,F Y, PY - 1992/11/1/pubmed PY - 1992/11/1/medline PY - 1992/11/1/entrez KW - Americas KW - Biology KW - Blood Coagulation Effects KW - Case Control Studies KW - Clinical Research KW - Clinical Trials KW - Contraception KW - Contraceptive Agents KW - Contraceptive Agents, Estrogen KW - Contraceptive Agents, Female KW - Contraceptive Agents, Progestin KW - Contraceptive Methods--side effects KW - Developed Countries KW - Diseases KW - Embolism KW - Ethinyl Estradiol KW - Family Planning KW - Florida KW - Hematological Effects KW - Hemic System KW - Levonorgestrel KW - Methodological Studies KW - Norethindrone KW - North America KW - Northern America KW - Oral Contraceptives, Combined--side effects KW - Oral Contraceptives, Phasic--side effects KW - Oral Contraceptives--side effects KW - Physiology KW - Research Methodology KW - Studies KW - Thromboembolism--prevention and control KW - United States KW - Vascular Diseases SP - 1255 EP - 61 JF - American journal of obstetrics and gynecology JO - Am J Obstet Gynecol VL - 167 IS - 5 N2 - OBJECTIVE: The effects of two triphasic oral contraceptives on coagulation and anticoagulation factors were compared in a 12-month open-label study. STUDY DESIGN: Fifty-two women (mean age 26 years) were enrolled in and completed the study; 20 had been randomly assigned to receive levonorgestrel plus ethinyl estradiol, 24 had been randomly assigned to receive norethindrone plus ethinyl estradiol, and eight surgically sterile women acted as untreated controls. Coagulation and anticoagulation factors were measured at baseline and during the sixth and twelfth months. RESULTS: Both oral contraceptives produced significant decreases from baseline in prothrombin time and partial thromboplastin time; there were also significant changes in laboratory control times. Factor XII was significantly increased in both oral contraceptive groups after 6 and 12 months. Fibrinogen antigen was significantly increased for norethindrone plus ethinyl estradiol after 6 and 12 months and for levonorgestrel plus ethinyl estradiol after 12 months. Platelet counts were unchanged. There was a significant increase in antithrombin III activity with norethindrone plus ethinyl estradiol at 12 months. Antithrombin III antigen was unchanged with the oral contraceptives; however, significant increases existed for alpha 1-antitrypsin antigen and plasminogen antigen and activity after 6 and 12 months and for alpha 2-macroglobulin antigen after 12 months for both oral contraceptives. alpha 2-Antiplasmin antigen was significantly increased for norethindrone plus ethinyl estradiol at the 12-month evaluation. There were no significant differences between the oral contraceptives for any coagulation or anticoagulation factor, and mean values generally remained within reference ranges. CONCLUSIONS: Levonorgestrel plus ethinyl estradiol and norethindrone plus ethinyl estradiol had equivalent, minimal effects on hemostasis, and changes in coagulation factors appeared to be balanced by changes in anticoagulation factors. SN - 0002-9378 UR - https://www.unboundmedicine.com/medline/citation/1442974/Changes_in_coagulation_and_anticoagulation_in_women_taking_low_dose_triphasic_oral_contraceptives:_a_controlled_comparative_12_month_clinical_trial_ DB - PRIME DP - Unbound Medicine ER -