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Efficacy and safety of a monophasic and a triphasic oral contraceptive containing norgestimate.
Am J Obstet Gynecol. 1994 May; 170(5 Pt 2):1556-61.AJ

Abstract

Both monophasic and triphasic formulations of ethinyl estradiol plus norgestimate, a progestin with marked progesterone-receptor affinity and minimal androgen-receptor affinity, have been evaluated in numerous clinical studies designed to determine if norgestimate's receptor-binding profile provides enhanced safety without a reduction in efficacy. To date clinical trials have shown that both formulations of ethinyl estradiol/norgestimate offer contraceptive efficacy equivalent to that of other oral contraceptives. Monophasic ethinyl estradiol/norgestimate was associated with an incidence of breakthrough bleeding and spotting similar to that of monophasic ethinyl estradiol/norgestrel and an incidence of amenorrhea less than that of ethinyl estradiol/norgestrel. Cycle control with triphasic ethinyl estradiol/norgestimate was similar to that with monophasic ethinyl estradiol/norgestimate. Weight gain and elevated blood pressure were insignificant in clinical trials with both fixed-dose and phasic ethinyl estradiol/norgestimate formulations. Perhaps of greatest importance, both monophasic and triphasic ethinyl estradiol/norgestimate formulations consistently showed favorable impact on metabolic parameters, including elevations in serum high-density lipoprotein cholesterol, and reductions in the low-density lipoprotein/high-density lipoprotein ratio, the parameter considered most sensitive for atherosclerotic risk. Both monophasic and triphasic ethinyl estradiol/norgestimate formulations were associated with minimal and clinically neutral effects on carbohydrate metabolism.

Authors+Show Affiliations

Philadelphia Fertility Institute, Pennsylvania Hospital, University of Pennsylvania School of Medicine 19107.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

8178906

Citation

Corson, S L.. "Efficacy and Safety of a Monophasic and a Triphasic Oral Contraceptive Containing Norgestimate." American Journal of Obstetrics and Gynecology, vol. 170, no. 5 Pt 2, 1994, pp. 1556-61.
Corson SL. Efficacy and safety of a monophasic and a triphasic oral contraceptive containing norgestimate. Am J Obstet Gynecol. 1994;170(5 Pt 2):1556-61.
Corson, S. L. (1994). Efficacy and safety of a monophasic and a triphasic oral contraceptive containing norgestimate. American Journal of Obstetrics and Gynecology, 170(5 Pt 2), 1556-61.
Corson SL. Efficacy and Safety of a Monophasic and a Triphasic Oral Contraceptive Containing Norgestimate. Am J Obstet Gynecol. 1994;170(5 Pt 2):1556-61. PubMed PMID: 8178906.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of a monophasic and a triphasic oral contraceptive containing norgestimate. A1 - Corson,S L, PY - 1994/5/1/pubmed PY - 1994/5/1/medline PY - 1994/5/1/entrez KW - Americas KW - Biology KW - Carbohydrate Metabolic Effects KW - Clinical Research KW - Clinical Trials KW - Comparative Studies KW - Contraception KW - Contraceptive Agents, Estrogen--administraction and dosage KW - Contraceptive Agents, Female--administraction and dosage KW - Contraceptive Agents, Progestin--administraction and dosage KW - Contraceptive Agents--administraction and dosage KW - Contraceptive Effectiveness KW - Contraceptive Methods--beneficial effects KW - Contraceptive Methods--side effects KW - Developed Countries KW - Ethinyl Estradiol--administraction and dosage KW - Family Planning KW - Health KW - Lipid Metabolic Effects KW - Lipids KW - Menstrual Cycle KW - Menstruation KW - Metabolic Effects KW - Norgestimate--administraction and dosage KW - North America KW - Northern America KW - Oral Contraceptives, Low-dose--beneficial effects KW - Oral Contraceptives, Low-dose--side effects KW - Oral Contraceptives--beneficial effects KW - Oral Contraceptives--side effects KW - Physiology KW - Public Health KW - Reproduction KW - Research Report KW - Safety KW - Studies KW - United States SP - 1556 EP - 61 JF - American journal of obstetrics and gynecology JO - Am J Obstet Gynecol VL - 170 IS - 5 Pt 2 N2 - Both monophasic and triphasic formulations of ethinyl estradiol plus norgestimate, a progestin with marked progesterone-receptor affinity and minimal androgen-receptor affinity, have been evaluated in numerous clinical studies designed to determine if norgestimate's receptor-binding profile provides enhanced safety without a reduction in efficacy. To date clinical trials have shown that both formulations of ethinyl estradiol/norgestimate offer contraceptive efficacy equivalent to that of other oral contraceptives. Monophasic ethinyl estradiol/norgestimate was associated with an incidence of breakthrough bleeding and spotting similar to that of monophasic ethinyl estradiol/norgestrel and an incidence of amenorrhea less than that of ethinyl estradiol/norgestrel. Cycle control with triphasic ethinyl estradiol/norgestimate was similar to that with monophasic ethinyl estradiol/norgestimate. Weight gain and elevated blood pressure were insignificant in clinical trials with both fixed-dose and phasic ethinyl estradiol/norgestimate formulations. Perhaps of greatest importance, both monophasic and triphasic ethinyl estradiol/norgestimate formulations consistently showed favorable impact on metabolic parameters, including elevations in serum high-density lipoprotein cholesterol, and reductions in the low-density lipoprotein/high-density lipoprotein ratio, the parameter considered most sensitive for atherosclerotic risk. Both monophasic and triphasic ethinyl estradiol/norgestimate formulations were associated with minimal and clinically neutral effects on carbohydrate metabolism. SN - 0002-9378 UR - https://www.unboundmedicine.com/medline/citation/8178906/Efficacy_and_safety_of_a_monophasic_and_a_triphasic_oral_contraceptive_containing_norgestimate_ L2 - https://linkinghub.elsevier.com/retrieve/pii/a54047 DB - PRIME DP - Unbound Medicine ER -