A norgestimate-containing oral contraceptive: Review of clinical studies
| Autor: | Michael E. Kafrissen |
|---|---|
| Rok vydání: | 1993 |
| Předmět: |
medicine.medical_specialty
medicine.drug_class Lipoproteins Pharmacology Carbohydrate metabolism Oral administration Cycle control Endocrine Glands Internal medicine Norgestrel Endocrine system Humans Medicine Pharmaceutical sciences Blood Coagulation Menstrual Cycle business.industry Body Weight Obstetrics and Gynecology General Medicine Norgestimate Lipids Clinical research Minimal effect Endocrinology Carbohydrate Metabolism Female business Progestin hormones hormone substitutes and hormone antagonists Contraceptives Oral medicine.drug Lipoprotein |
| Zdroj: | International Journal of Gynecology & Obstetrics. 41:335-335 |
| ISSN: | 0020-7292 |
| DOI: | 10.1016/0020-7292(93)90602-s |
| Popis: | Despite the well-documented efficacy and safety of low-dose oral contraceptives, the development of newer formulations containing highly selective progestins with minimal or no androgenic activity has been a goal of pharmaceutical research. The efficacy and safety of norgestimate, a progestin with inherently low androgenicity, in combination with ethinyl estradiol, has been examined in several phase II and phase III clinical studies, and these are reviewed. Norgestimate/ethinyl estradiol has proved to be a low-dose oral contraceptive with high selectivity that provides the cycle control of older oral contraceptive formulations with comparable efficacy. Results of comparison studies between norgestimate/ethinyl estradiol and formulations containing norgestrel, a progestin with relatively greater androgenic activity, in combination with ethinyl estradiol, are reported for effects on lipid and lipoprotein levels and carbohydrate metabolism. Norgestimate/ethinyl estradiol consistently produced statistically significant increases in high-density lipoprotein cholesterol and improvement in the ratio of low-density lipoprotein cholesterol to high-density lipoprotein. In contrast, norgestrel/ethinyl estradiol produced statistically significant decreases in high-density lipoprotein cholesterol and potentially adverse changes in the low-density/high-density lipoprotein ratio. Phase II studies have confirmed that norgestimate/ethinyl estradiol has low androgenic activity and causes minimal effect on coagulation factors and carbohydrate metabolism.Despite the well-documented efficacy and safety of low-dose oral contraceptives (OCs), the development of newer formulations containing highly selective progestins with minimal or no androgenic activity has been a goal of pharmaceutical research. The efficacy and safety of norgestimate, a progestin with inherently low androgenicity, in combination with ethinyl estradiol (EE), has been examined in several phase II and phase III clinical studies, and these are here reviewed. Norgestimate/EE has proven to be a low-dose OC with high selectivity which provides the cycle control of older OC formulations with comparable efficacy. The results of comparison studies between norgestimate/EE and formulations containing norgestrel, a progestin with relatively greater androgenic activity, in combination with EE, are reported for effects on lipid and lipoprotein levels and carbohydrate metabolism. Norgestimate/EE consistently produced statistically significant increases in high-density lipoprotein (HDL) cholesterol and improvement in the ratio of low-density lipoprotein (LDL) cholesterol to HDL. In contrast, norgestrel/EE produced statistically significant decreases in HDL cholesterol and potentially adverse changes in the LDL/HDL ratio. Phase II studies have confirmed that norgestimate/EE has low androgenic activity and causes minimal effects on coagulation factors and carbohydrate metabolism. |
| Databáze: | OpenAIRE |
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