Biomaterial Database

Clinical evaluation of a new triphasic oral contraceptive: norgestimate and ethinyl estradiol. 1992

A Gauthier, and D Upmalis, and M P Dain

Service de Gynecologie Sociale, Centre Hospitalier, Lille, France.

The safety and efficacy of the triphasic oral contraceptive agent containing norgestimate and ethinyl estradiol were evaluated in a 12-month study of 661 women. Excellent contraceptive efficacy was achieved, with two pregnancies ascribed to product failure in a total of 6,511 treatment cycles. The life-table predicted pregnancy rate was 0.57 per 100 woman-years of use. The overall and theoretical Pearl indexes were 0.55 and 0.37, respectively. Good cycle control was maintained in patterns similar to those noted in previous studies. The incidence of dysmenorrhea and premenstrual syndrome was sharply reduced. Side effects reported were typical of those associated with use of low-dose oral contraceptive agents. Acceptability was high compared with agents used previously by the subjects. Total cholesterol did not change but high-density lipoprotein cholesterol was significantly elevated at 3 and 12 months. There were no clinically significant changes in the parameters of hematology or blood chemistry tested.

UI	MeSH Term	Description	Entries
D008055	Lipids	A generic term for fats and lipoids, the alcohol-ether-soluble constituents of protoplasm, which are insoluble in water. They comprise the fats, fatty oils, essential oils, waxes, phospholipids, glycolipids, sulfolipids, aminolipids, chromolipids (lipochromes), and fatty acids. (Grant & Hackh's Chemical Dictionary, 5th ed)	Lipid
D008597	Menstrual Cycle	The period from onset of one menstrual bleeding (MENSTRUATION) to the next in an ovulating woman or female primate. The menstrual cycle is regulated by endocrine interactions of the HYPOTHALAMUS; the PITUITARY GLAND; the ovaries; and the genital tract. The menstrual cycle is divided by OVULATION into two phases. Based on the endocrine status of the OVARY, there is a FOLLICULAR PHASE and a LUTEAL PHASE. Based on the response in the ENDOMETRIUM, the menstrual cycle is divided into a proliferative and a secretory phase.	Endometrial Cycle,Ovarian Cycle,Cycle, Endometrial,Cycle, Menstrual,Cycle, Ovarian,Cycles, Endometrial,Cycles, Menstrual,Cycles, Ovarian,Endometrial Cycles,Menstrual Cycles,Ovarian Cycles
D009644	Norgestrel	A synthetic progestational agent with actions similar to those of PROGESTERONE. This racemic or (+-)-form has about half the potency of the levo form (LEVONORGESTREL). Norgestrel is used as a contraceptive, ovulation inhibitor, and for the control of menstrual disorders and endometriosis.	18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17alpha)-(+-)-,DL-Norgestrel,Neogest,Ovrette,Postinor,Wy-3707,DL Norgestrel,Wy 3707,Wy3707
D010349	Patient Compliance	Voluntary cooperation of the patient in following a prescribed regimen.	Client Adherence,Client Compliance,Non-Adherent Patient,Patient Adherence,Patient Cooperation,Patient Noncompliance,Patient Non-Adherence,Patient Non-Compliance,Patient Nonadherence,Therapeutic Compliance,Treatment Compliance,Adherence, Client,Adherence, Patient,Client Compliances,Compliance, Client,Compliance, Patient,Compliance, Therapeutic,Compliance, Treatment,Cooperation, Patient,Non Adherent Patient,Non-Adherence, Patient,Non-Adherent Patients,Non-Compliance, Patient,Nonadherence, Patient,Noncompliance, Patient,Patient Non Adherence,Patient Non Compliance,Patient, Non-Adherent,Therapeutic Compliances,Treatment Compliances
D011247	Pregnancy	The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.	Gestation,Pregnancies
D001786	Blood Glucose	Glucose in blood.	Blood Sugar,Glucose, Blood,Sugar, Blood
D003277	Contraceptives, Oral, Combined	Fixed drug combinations administered orally for contraceptive purposes.	Combined Oral Contraceptive,Contraceptive Agents, Female, Combined,Oral Contraceptives, Combined,Combined Oral Contraceptives,Contraceptive, Combined Oral,Contraceptives, Combined Oral,Oral Contraceptive, Combined
D004997	Ethinyl Estradiol	A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.	19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17alpha)-,Ethynyl Estradiol,Estinyl,Ethinyl Estradiol Hemihydrate,Ethinyl Estradiol, (8 alpha)-Isomer,Ethinyl Estradiol, (8 alpha,17 alpha)-Isomer,Ethinyl Estradiol, (8 alpha,9 beta,13 alpha,14 beta)-Isomer,Ethinyl Estradiol, (9 beta,17 alpha)-Isomer,Ethinyl-Oestradiol Effik,Ethinylestradiol Jenapharm,Ethinyloestradiol,Lynoral,Microfollin,Microfollin Forte,Progynon C,Estradiol, Ethinyl,Estradiol, Ethynyl,Ethinyl Oestradiol Effik,Hemihydrate, Ethinyl Estradiol,Jenapharm, Ethinylestradiol
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man