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Efficacy and clinical profile of a new oral contraceptive containing norgestimate. U.S. clinical trials.

Abstract

The search for a highly selective progestin that exerts a potent and targeted progestational response with minimal or absent androgenic effect has paralleled investigation into the possible impact of these agents on cardiovascular disease in women. Such a progestin, norgestimate (NGM), in a dose of 250 micrograms, has been combined with ethinyl estradiol (EE) 35 micrograms in a new oral contraceptive (OC), Ortho-Cyclen or Cilest. Results of two long-term, multicentric clinical trials demonstrate that this formulation is comparable in efficacy to the norgestrel-containing OC Lo/Ovral. There were no statistically significant differences in pregnancy rate, and both OCs were well-tolerated in a large and diverse study population. In several areas, however, the inherently lower androgenicity of the norgestimate OC produced clinical changes compared with the norgestrel formulation. These changes were primarily evident in the more natural menstrual patterns with the norgestimate OC, its less severe impact on the endometrium, and, most important, its positive impact on lipoprotein metabolism. NGM/EE consistently produced statistically significant increases in high density lipoprotein (HDL) and concomitant improvement in the ratio of low density lipoprotein (LDL) to HDL. By cycle 24, this highly predictive parameter of atherosclerotic risk had decreased 7.7% in the NGM/EE group. Conversely, the norgestrel-containing formulation resulted in statistically significant decreases in HDL and increases in the LDL/HDL ratio; by cycle 24, these patients showed an 18.5% increase in the LDL/HDL ratio. All between regimen comparisons of mean changes in the LDL/HDL ratio were statistically significant, from baseline through cycles 3, 6, 12 and 24.

Authors+Show Affiliations

Philadelphia Fertility Institute, Pennsylvania Hospital, University of Pennsylvania School of Medicine.

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study

Language

eng

PubMed ID

2189282

Citation

Corson, S L.. "Efficacy and Clinical Profile of a New Oral Contraceptive Containing Norgestimate. U.S. Clinical Trials." Acta Obstetricia Et Gynecologica Scandinavica. Supplement, vol. 152, 1990, pp. 25-31.
Corson SL. Efficacy and clinical profile of a new oral contraceptive containing norgestimate. U.S. clinical trials. Acta Obstet Gynecol Scand Suppl. 1990;152:25-31.
Corson, S. L. (1990). Efficacy and clinical profile of a new oral contraceptive containing norgestimate. U.S. clinical trials. Acta Obstetricia Et Gynecologica Scandinavica. Supplement, 152, 25-31.
Corson SL. Efficacy and Clinical Profile of a New Oral Contraceptive Containing Norgestimate. U.S. Clinical Trials. Acta Obstet Gynecol Scand Suppl. 1990;152:25-31. PubMed PMID: 2189282.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and clinical profile of a new oral contraceptive containing norgestimate. U.S. clinical trials. A1 - Corson,S L, PY - 1990/1/1/pubmed PY - 1990/1/1/medline PY - 1990/1/1/entrez KW - Americas KW - Biology KW - Carbohydrate Metabolic Effects KW - Cervical Mucus--analysis KW - Cervix KW - Clinical Research KW - Contraception KW - Contraceptive Agents KW - Contraceptive Agents, Female KW - Contraceptive Agents, Progestin KW - Contraceptive Usage KW - Developed Countries KW - Endocrine Effects KW - Endocrine System KW - Evaluation KW - Family Planning KW - Genitalia KW - Genitalia, Female KW - Glucose Metabolism Effects KW - Lipid Metabolic Effects KW - Lipids KW - Menstrual Cycle KW - Menstruation KW - Metabolic Effects KW - Method Acceptability KW - North America KW - Northern America KW - Physiology KW - Reproduction KW - Research Methodology KW - United States KW - Urogenital System KW - Uterus SP - 25 EP - 31 JF - Acta obstetricia et gynecologica Scandinavica. Supplement JO - Acta Obstet Gynecol Scand Suppl VL - 152 N2 - The search for a highly selective progestin that exerts a potent and targeted progestational response with minimal or absent androgenic effect has paralleled investigation into the possible impact of these agents on cardiovascular disease in women. Such a progestin, norgestimate (NGM), in a dose of 250 micrograms, has been combined with ethinyl estradiol (EE) 35 micrograms in a new oral contraceptive (OC), Ortho-Cyclen or Cilest. Results of two long-term, multicentric clinical trials demonstrate that this formulation is comparable in efficacy to the norgestrel-containing OC Lo/Ovral. There were no statistically significant differences in pregnancy rate, and both OCs were well-tolerated in a large and diverse study population. In several areas, however, the inherently lower androgenicity of the norgestimate OC produced clinical changes compared with the norgestrel formulation. These changes were primarily evident in the more natural menstrual patterns with the norgestimate OC, its less severe impact on the endometrium, and, most important, its positive impact on lipoprotein metabolism. NGM/EE consistently produced statistically significant increases in high density lipoprotein (HDL) and concomitant improvement in the ratio of low density lipoprotein (LDL) to HDL. By cycle 24, this highly predictive parameter of atherosclerotic risk had decreased 7.7% in the NGM/EE group. Conversely, the norgestrel-containing formulation resulted in statistically significant decreases in HDL and increases in the LDL/HDL ratio; by cycle 24, these patients showed an 18.5% increase in the LDL/HDL ratio. All between regimen comparisons of mean changes in the LDL/HDL ratio were statistically significant, from baseline through cycles 3, 6, 12 and 24. SN - 0300-8835 UR - https://www.unboundmedicine.com/medline/citation/2189282/Efficacy_and_clinical_profile_of_a_new_oral_contraceptive_containing_norgestimate__U_S__clinical_trials_ DB - PRIME DP - Unbound Medicine ER -