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Comparative contraceptive efficacy and mechanism of action of the norgestimate-containing triphasic oral contraceptive.

Abstract

Norgestimate (NGM), a derivative of 19-nortestosterone with very specific affinity for the progesterone receptor, has been used in combination with ethinyl estradiol (EE) at low doses in both monophasic and triphasic oral contraceptives (OCs). An open-label comparative clinical trial was conducted with 4,234 healthy women using comparative clinical trial was conducted with 4,234 healthy women using triphasic levonorgestrel (LUG)/EE and NGM/EE through a total of 22,312 menstrual cycles. Contraceptive (LUG)/EE and NGM/EE through a total of 22,312 menstrual cycles. Contraceptive efficacy was excellent with both preparations, with no statistically significant between-regimen differences in pregnancy rates. The theoretical Pearl index was the NGM/EE triphasic, and 0.34 for the LNG/EE triphasic. Adverse experiences in groups were typical of those that may occur among women taking low-dose OC agents. was similar with the two preparations: 8.6% for the NGM/EE triphasic and 6.8% for the LNG/EE triphasic. In a separate mechanism of action study, specific endocrine parameters were investigated in 20 subjects using the NGM/EE triphasic for 4 cycles. Ovulation suppression was demonstrated in statistically significant decreases from pretreatment values in serum levels of luteinizing hormone, follicle-stimulating hormone, progesterone, and estradiol. Significant on-treatment increases in serum levels of sex hormone binding globulin evidenced minimal androgenicity. All hormonal values returned to or toward normal in the post-treatment cycle. The study results support those obtained in large noncomparative studies of the NGM/EE triphasic. This phased-dose combination suppresses ovulation and is a very effective, minimally androgenic contraceptive agent with a good safety profile.

Authors+Show Affiliations

Kaiser Permanente, Baltimore, Maryland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

1324557

Citation

London, R S., et al. "Comparative Contraceptive Efficacy and Mechanism of Action of the Norgestimate-containing Triphasic Oral Contraceptive." Acta Obstetricia Et Gynecologica Scandinavica. Supplement, vol. 156, 1992, pp. 9-14.
London RS, Chapdelaine A, Upmalis D, et al. Comparative contraceptive efficacy and mechanism of action of the norgestimate-containing triphasic oral contraceptive. Acta Obstet Gynecol Scand Suppl. 1992;156:9-14.
London, R. S., Chapdelaine, A., Upmalis, D., Olson, W., & Smith, J. (1992). Comparative contraceptive efficacy and mechanism of action of the norgestimate-containing triphasic oral contraceptive. Acta Obstetricia Et Gynecologica Scandinavica. Supplement, 156, 9-14.
London RS, et al. Comparative Contraceptive Efficacy and Mechanism of Action of the Norgestimate-containing Triphasic Oral Contraceptive. Acta Obstet Gynecol Scand Suppl. 1992;156:9-14. PubMed PMID: 1324557.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative contraceptive efficacy and mechanism of action of the norgestimate-containing triphasic oral contraceptive. AU - London,R S, AU - Chapdelaine,A, AU - Upmalis,D, AU - Olson,W, AU - Smith,J, PY - 1992/1/1/pubmed PY - 1992/1/1/medline PY - 1992/1/1/entrez KW - Biology KW - Carbohydrate Metabolic Effects KW - Comparative Studies KW - Contraception KW - Contraceptive Agents KW - Contraceptive Agents, Estrogen KW - Contraceptive Agents, Female KW - Contraceptive Agents, Progestin KW - Contraceptive Effectiveness KW - Contraceptive Methods--side effects KW - Contraceptive Mode Of Action KW - Data Analysis KW - Endocrine Effects KW - Endocrine System KW - Estradiol--analysis KW - Estrogens KW - Ethinyl Estradiol KW - Family Planning KW - Follicle Stimulating Hormone--analysis KW - Gonadotropins KW - Gonadotropins, Pituitary KW - Hormones KW - Lipid Metabolic Effects KW - Lipids KW - Luteinizing Hormone--analysis KW - Metabolic Effects KW - Norgestimate KW - Oral Contraceptives, Combined--side effects KW - Oral Contraceptives, Phasic--side effects KW - Oral Contraceptives--side effects KW - Ovulation Suppression KW - Physiology KW - Progestational Hormones KW - Progesterone--analysis KW - Research Methodology KW - Studies SP - 9 EP - 14 JF - Acta obstetricia et gynecologica Scandinavica. Supplement JO - Acta Obstet Gynecol Scand Suppl VL - 156 N2 - Norgestimate (NGM), a derivative of 19-nortestosterone with very specific affinity for the progesterone receptor, has been used in combination with ethinyl estradiol (EE) at low doses in both monophasic and triphasic oral contraceptives (OCs). An open-label comparative clinical trial was conducted with 4,234 healthy women using comparative clinical trial was conducted with 4,234 healthy women using triphasic levonorgestrel (LUG)/EE and NGM/EE through a total of 22,312 menstrual cycles. Contraceptive (LUG)/EE and NGM/EE through a total of 22,312 menstrual cycles. Contraceptive efficacy was excellent with both preparations, with no statistically significant between-regimen differences in pregnancy rates. The theoretical Pearl index was the NGM/EE triphasic, and 0.34 for the LNG/EE triphasic. Adverse experiences in groups were typical of those that may occur among women taking low-dose OC agents. was similar with the two preparations: 8.6% for the NGM/EE triphasic and 6.8% for the LNG/EE triphasic. In a separate mechanism of action study, specific endocrine parameters were investigated in 20 subjects using the NGM/EE triphasic for 4 cycles. Ovulation suppression was demonstrated in statistically significant decreases from pretreatment values in serum levels of luteinizing hormone, follicle-stimulating hormone, progesterone, and estradiol. Significant on-treatment increases in serum levels of sex hormone binding globulin evidenced minimal androgenicity. All hormonal values returned to or toward normal in the post-treatment cycle. The study results support those obtained in large noncomparative studies of the NGM/EE triphasic. This phased-dose combination suppresses ovulation and is a very effective, minimally androgenic contraceptive agent with a good safety profile. SN - 0300-8835 UR - https://www.unboundmedicine.com/medline/citation/1324557/Comparative_contraceptive_efficacy_and_mechanism_of_action_of_the_norgestimate_containing_triphasic_oral_contraceptive_ L2 - https://antibodies.cancer.gov/detail/CPTC-PGR-2 DB - PRIME DP - Unbound Medicine ER -