A randomized, double-blind study of two combined oral contraceptives containing the same progestogen, but different estrogens. World Health Organization Task Force on Oral Contraception. 1980


The results are reported of a randomized, double-blind study of two daily oral contraceptives, both containing 3mg norethisterone acetate; one also contained 50 microgram ethinyl estradiol, while the other contained a mixture of micronized 4mg estradiol plus 2mg estriol. The trial was conducted to a common protocol at WHO Collaborating Centres for Clinical Research (CCCR's) in Bangkok, Bombay, Singapore and Szeged. Of the 925 women who entered the study, 458 received the product containing "natural" estrogens and 467 received the product containing ethinyl estradiol. Analysis of admission characteristics showed that the two groups were very closely matched. There was no statistically significant difference in contraceptive efficacy between the two products; both have annual failure rates of approximately 1 per 100 women. The discontinuation rate after one year was 51.5 for the "natural" estrogen product and 48.4 for the one containing synthetic estrogen. Discontinuation for menstrual irregularities was significantly higher for the "natural" estrogen preparation. During both the first three treatment cycles and the tenth to twelfth cycles, the incidence of various menstrual irregularities was significantly higher in the "natural" estrogen contraceptive. Adverse clinical associations were those commonly reported with other combined oral contraceptives for both preparations. It is concluded that the high incidence of menstrual irregularities associated with the particular combination of norethisterone acetate and "natural" estrogens renders it less suitable for general use in family planning programmes than combinations containing synthetic estrogens, such as ethinyl estradiol.

UI MeSH Term Description Entries
D009640 Norethindrone A synthetic progestational hormone with actions similar to those of PROGESTERONE but functioning as a more potent inhibitor of ovulation. It has weak estrogenic and androgenic properties. The hormone has been used in treating amenorrhea, functional uterine bleeding, endometriosis, and for CONTRACEPTION. 19-Norpregn-4-en-20-yn-3-one, 17-hydroxy-, (17alpha)-,Ethinylnortestosterone,Norethisterone,Norpregneninolone,Conceplan,Micronor,Monogest,Nor-QD,Norcolut,Norcolute,Norethindrone, (1 beta)-Isomer,Norlutin,Nor QD,NorQD
D003276 Contraceptives, Oral Compounds, usually hormonal, taken orally in order to block ovulation and prevent the occurrence of pregnancy. The hormones are generally estrogen or progesterone or both. Low-Dose Oral Contraceptive,Oral Contraceptive,Oral Contraceptives,Oral Contraceptives, Low-Dose,Oral Contraceptives, Phasic,Contraceptive, Low-Dose Oral,Contraceptive, Oral,Contraceptives, Low-Dose Oral,Contraceptives, Phasic Oral,Low Dose Oral Contraceptive,Low-Dose Oral Contraceptives,Oral Contraceptive, Low-Dose,Oral Contraceptives, Low Dose,Phasic Oral Contraceptives
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
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004958 Estradiol The 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol-17-beta is the most potent form of mammalian estrogenic steroids. 17 beta-Estradiol,Estradiol-17 beta,Oestradiol,17 beta-Oestradiol,Aerodiol,Delestrogen,Estrace,Estraderm TTS,Estradiol Anhydrous,Estradiol Hemihydrate,Estradiol Hemihydrate, (17 alpha)-Isomer,Estradiol Monohydrate,Estradiol Valerate,Estradiol Valeriante,Estradiol, (+-)-Isomer,Estradiol, (-)-Isomer,Estradiol, (16 alpha,17 alpha)-Isomer,Estradiol, (16 alpha,17 beta)-Isomer,Estradiol, (17-alpha)-Isomer,Estradiol, (8 alpha,17 beta)-(+-)-Isomer,Estradiol, (8 alpha,17 beta)-Isomer,Estradiol, (9 beta,17 alpha)-Isomer,Estradiol, (9 beta,17 beta)-Isomer,Estradiol, Monosodium Salt,Estradiol, Sodium Salt,Estradiol-17 alpha,Estradiol-17beta,Ovocyclin,Progynon-Depot,Progynova,Vivelle,17 beta Estradiol,17 beta Oestradiol,Estradiol 17 alpha,Estradiol 17 beta,Estradiol 17beta,Progynon Depot
D004964 Estriol A hydroxylated metabolite of ESTRADIOL or ESTRONE that has a hydroxyl group at C3, 16-alpha, and 17-beta position. Estriol is a major urinary estrogen. During PREGNANCY, a large amount of estriol is produced by the PLACENTA. Isomers with inversion of the hydroxyl group or groups are called epiestriol. (16alpha,17beta)-Estra-1,3,5(10)-Triene-3,16,17-Triol,(16beta,17beta)-Estra-1,3,5(10)-Triene-3,16,17-Triol,16-alpha-Hydroxy-Estradiol,16alpha,17beta-Estriol,16beta-Hydroxy-Estradiol,Epiestriol,Estra-1,3,5(10)-Triene-3,16beta,17beta-Triol,Ovestin,16 alpha Hydroxy Estradiol,16alpha,17beta Estriol,16beta Hydroxy Estradiol
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
D000293 Adolescent A person 13 to 18 years of age. Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths

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