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Cycle control with triphasic norgestimate and ethinyl estradiol, a new oral contraceptive agent.

Abstract

Effective cycle control was demonstrated based on two multicenter, 2-year studies of the triphasic oral contraceptive (OC) agent containing the new progestin norgestimate. The estrogen in this OC is ethinyl estradiol. These open-label Phase III studies were conducted in the United States by 33 investigators at 33 sites who treated a total of 1,783 subjects, healthy women 17 to 38 years of age with menstrual cycle characteristics considered to be within the normal range. The norgestimate/ethinyl estradiol preparation was taken for up to 24 cycles. Follow-up information was collected 3 to 4 months post-treatment. Bleeding pattern analyses were based on 27,970 valid cycles. Normal cyclic bleeding patterns were experienced by most of the women during the study; only minimal and statistically and clinically insignificant variations in menstrual flow, dysmenorrhea, and premenstrual tension occurred. There was a low incidence of failed withdrawal bleeding in single cycles (less than 1.0% after cycle 6). There were no cases of amenorrhea, defined as two consecutive cycles of missed withdrawal flow. The incidence of breakthrough bleeding or spotting was highest during the initial treatment cycles and diminished with continued use of the formulation. The mean incidence of breakthrough bleeding was 2.36% in cycles 13 to 24. Apart from somewhat higher initial percentages among women new to oral contraception, the pattern of midcycle bleeding or spotting was similar to that of all women studied. Effective long-term cycle control was demonstrated in women who used this OC agent.

Authors+Show Affiliations

Department of Community and Family Medicine, Duke University Medical Center, Durham, North Carolina.

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study

Language

eng

PubMed ID

1324553

Citation

Andolsek, K M.. "Cycle Control With Triphasic Norgestimate and Ethinyl Estradiol, a New Oral Contraceptive Agent." Acta Obstetricia Et Gynecologica Scandinavica. Supplement, vol. 156, 1992, pp. 22-6.
Andolsek KM. Cycle control with triphasic norgestimate and ethinyl estradiol, a new oral contraceptive agent. Acta Obstet Gynecol Scand Suppl. 1992;156:22-6.
Andolsek, K. M. (1992). Cycle control with triphasic norgestimate and ethinyl estradiol, a new oral contraceptive agent. Acta Obstetricia Et Gynecologica Scandinavica. Supplement, 156, 22-6.
Andolsek KM. Cycle Control With Triphasic Norgestimate and Ethinyl Estradiol, a New Oral Contraceptive Agent. Acta Obstet Gynecol Scand Suppl. 1992;156:22-6. PubMed PMID: 1324553.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cycle control with triphasic norgestimate and ethinyl estradiol, a new oral contraceptive agent. A1 - Andolsek,K M, PY - 1992/1/1/pubmed PY - 1992/1/1/medline PY - 1992/1/1/entrez KW - Americas KW - Bleeding KW - Clinical Research KW - Clinical Trials KW - Contraception KW - Contraceptive Agents KW - Contraceptive Agents, Estrogen KW - Contraceptive Agents, Female KW - Contraceptive Agents, Progestin KW - Contraceptive Methods--side effects KW - Contraceptive Usage KW - Data Collection KW - Demographic Factors KW - Developed Countries KW - Diseases KW - Ethinyl Estradiol KW - Family Planning KW - Incidence KW - Measurement KW - Menstrual Cycle--changes KW - Menstruation KW - Method Acceptability KW - Metrorrhagia KW - Norgestimate KW - North America KW - Northern America KW - Oral Contraceptives, Combined--side effects KW - Oral Contraceptives, Phasic--side effects KW - Oral Contraceptives--side effects KW - Population KW - Reproduction KW - Research Methodology KW - Signs And Symptoms KW - United States SP - 22 EP - 6 JF - Acta obstetricia et gynecologica Scandinavica. Supplement JO - Acta Obstet Gynecol Scand Suppl VL - 156 N2 - Effective cycle control was demonstrated based on two multicenter, 2-year studies of the triphasic oral contraceptive (OC) agent containing the new progestin norgestimate. The estrogen in this OC is ethinyl estradiol. These open-label Phase III studies were conducted in the United States by 33 investigators at 33 sites who treated a total of 1,783 subjects, healthy women 17 to 38 years of age with menstrual cycle characteristics considered to be within the normal range. The norgestimate/ethinyl estradiol preparation was taken for up to 24 cycles. Follow-up information was collected 3 to 4 months post-treatment. Bleeding pattern analyses were based on 27,970 valid cycles. Normal cyclic bleeding patterns were experienced by most of the women during the study; only minimal and statistically and clinically insignificant variations in menstrual flow, dysmenorrhea, and premenstrual tension occurred. There was a low incidence of failed withdrawal bleeding in single cycles (less than 1.0% after cycle 6). There were no cases of amenorrhea, defined as two consecutive cycles of missed withdrawal flow. The incidence of breakthrough bleeding or spotting was highest during the initial treatment cycles and diminished with continued use of the formulation. The mean incidence of breakthrough bleeding was 2.36% in cycles 13 to 24. Apart from somewhat higher initial percentages among women new to oral contraception, the pattern of midcycle bleeding or spotting was similar to that of all women studied. Effective long-term cycle control was demonstrated in women who used this OC agent. SN - 0300-8835 UR - https://www.unboundmedicine.com/medline/citation/1324553/Cycle_control_with_triphasic_norgestimate_and_ethinyl_estradiol_a_new_oral_contraceptive_agent_ DB - PRIME DP - Unbound Medicine ER -