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A norgestimate-containing oral contraceptive: review of clinical studies.
Am J Obstet Gynecol. 1992 Oct; 167(4 Pt 2):1196-202.AJ

Abstract

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.

Authors+Show Affiliations

R. W. Johnson Pharmaceutical Research Institute, Raritan, NJ 08869-0602.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

1415446

Citation

Kafrissen, M E.. "A Norgestimate-containing Oral Contraceptive: Review of Clinical Studies." American Journal of Obstetrics and Gynecology, vol. 167, no. 4 Pt 2, 1992, pp. 1196-202.
Kafrissen ME. A norgestimate-containing oral contraceptive: review of clinical studies. Am J Obstet Gynecol. 1992;167(4 Pt 2):1196-202.
Kafrissen, M. E. (1992). A norgestimate-containing oral contraceptive: review of clinical studies. American Journal of Obstetrics and Gynecology, 167(4 Pt 2), 1196-202.
Kafrissen ME. A Norgestimate-containing Oral Contraceptive: Review of Clinical Studies. Am J Obstet Gynecol. 1992;167(4 Pt 2):1196-202. PubMed PMID: 1415446.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A norgestimate-containing oral contraceptive: review of clinical studies. A1 - Kafrissen,M E, PY - 1992/10/1/pubmed PY - 1992/10/1/medline PY - 1992/10/1/entrez KW - Biology KW - Blood Coagulation Effects KW - Carbohydrate Metabolic Effects KW - Clinical Research KW - Contraception KW - Contraceptive Agents KW - Contraceptive Agents, Estrogen KW - Contraceptive Agents, Female KW - Contraceptive Agents, Progestin KW - Contraceptive Methods KW - Endocrine Effects KW - Endocrine System KW - Ethinyl Estradiol KW - Family Planning KW - Hematological Effects KW - Hemic System KW - Lipid Metabolic Effects KW - Lipids KW - Metabolic Effects KW - Norgestimate KW - Norgestrel KW - Oral Contraceptives KW - Oral Contraceptives, Combined KW - Oral Contraceptives, Low-dose KW - Physiology KW - Research Methodology SP - 1196 EP - 202 JF - American journal of obstetrics and gynecology JO - Am J Obstet Gynecol VL - 167 IS - 4 Pt 2 N2 - 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. SN - 0002-9378 UR - https://www.unboundmedicine.com/medline/citation/1415446/A_norgestimate_containing_oral_contraceptive:_review_of_clinical_studies_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9378(12)90411-1 DB - PRIME DP - Unbound Medicine ER -