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The clinical evaluation of drugs used in fertility regulation is initially assessed in Phase I, II and III trials. The design of each phase and the investigative staff must be adequate. In Phase I, normal, healthy human volunteers meeting specific guidelines are usually studied. Numbers vary between 20 and 80 and the purpose is to determine the acute toxicity of the compound. In Phase II, efficacy and safety are examined in a clinical target population, and emphasis may be placed on pharmacological and mechanistic studies. Usually between 50 and 200 patients are involved. In Phase III, large-scale clinical studies for local registration and the introduction of drugs to various countries are included. This paper describes the evaluation of various drugs used in contraception, including NORPLANT implants, and considers the efficiency, safety and acceptability of such drugs. Phase IV studies are usually needed to reveal chronic toxicities or rare events.

Titel:	Clinical evaluation of drugs used in fertility regulation.
Autor/in / Beteiligte Person:	Siemens, AJ
Link:	Full Text Finder (Volltext)
Zeitschrift:	Human reproduction (Oxford, England), Jg. 1 (1986-09-01), Heft 6, S. 405-10
Veröffentlichung:	Oxford, UK : Oxford University Press ; <i>Original Publication</i>: Oxford ; Washington, DC : Published for the European Society of Human Reproduction and Embryology by IRL Press, [c1986-, 1986
Medientyp:	academicJournal
ISSN:	0268-1161 (print)
DOI:	10.1093/oxfordjournals.humrep.a136436
Schlagwort:	Humans Levonorgestrel Norgestrel adverse effects Clinical Trials as Topic Contraceptive Agents, Female adverse effects Drug Evaluation
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Journal Article Language: English [Hum Reprod] 1986 Sep; Vol. 1 (6), pp. 405-10. MeSH Terms: Clinical Trials as Topic* ; Drug Evaluation* ; Contraceptive Agents, Female / adverse effects ; Humans ; Levonorgestrel ; Norgestrel / adverse effects Contributed Indexing: Indexing Agency: PIP Local ID #: 044152. Indexing Agency: POP Local ID #: 00169847. ; Keywords: Barrier Methods; Biology; Clinical Research; Contraception; Contraceptive Agents; Contraceptive Agents, Female; Contraceptive Agents, Progestin--side effects; Contraceptive Agents--side effects; Contraceptive Effectiveness; Contraceptive Implants--side effects; Contraceptive Methods--side effects; Diseases; Economic Factors; Endocrine System; Evaluation; Evaluation Methodology; Family Planning; Genital Effects, Female; Hormones; Measurement; Menstruation Disorders; Norethindrone--side effects; Physiology; Qualitative Evaluation; Reproductive Control Agents; Research And Development; Research Methodology; Spermicidal Contraceptive Agents; Study Design; Technology; Urogenital Effects; Use-effectiveness; Vaginal Approach; Vaginal Barrier Methods; Vaginal Sponge* ; Note: TJ: HUMAN REPRODUCTION ; Local Abstract: [PIP] The nature of clinical studies in Phases I to III of various drugs used in contraception, including Norplant implants, are described. International ethical standards generally agree that subjects should give informed consent before entering a study. Study subjects in Phase I of clinical evaluation are generally normal human volunteers who meet very specific selection guidelines. In special cases a target population of patients might be studied. Typically, the number of subjects studied in this phase ranges from 20-80 depending upon the specific product and the specific study objectives. The primary purpose of Phase I studies is to determine the acute toxicity potential of the product. In addition, one may want to determine the pharmacological or metabolic effects of the product. Family Health International (FHI) currently is planning the development of a new vaginal contraceptive product (FD 100). Initial studies will focus on safety parameters associated with the vaginal route. A subsequent Phase I study of FD 100 will provide an initial assessment of efficacy as well as safety. Phase II studies typically provide an opportunity to examine issues of efficacy and safety in a clinical target population and often permit a determination of the dose and dose intervals which will be most appropriate for that particular population and allow for a more definitive evaluation of the pharmacokinetics and, perhaps, bioavailability of a particular formulation. Typically, between 50-200 subjects are enrolled in a series of Phase II studies. The Program for Applied Research on Fertility Regulation and FHI recently have conducted a Phase II evaluation of a norethindrone (NET) pellet implant system. The most important side effect associated with this implant system consisted of changes in menstrual patterns. The Norplant subdermal implant system is in advanced stages of Phase III evaluation in the US and in selected other countries. In all study countries, the principal investigators are specialists in obstetrics and gynecology and the implants are offered to 400-600 healthy, nonlactating women who want to limit their family size. Beyond a typical study of product safety and efficacy, the novel nature of this implant technology has required the incorporation of special approaches into the multinational Phase III evaluation of the Norplant system. The Today-TM contraceptive sponge was approved for marketing by the Food and Drug Administration in 1983 based largely upon a multicenter study conducted by FHI in the US. Substance Nomenclature: 0 (Contraceptive Agents, Female) ; 3J8Q1747Z2 (Norgestrel) ; 5W7SIA7YZW (Levonorgestrel) Entry Date(s): Date Created: 19860901 Date Completed: 19870428 Latest Revision: 20190510 Update Code: 20231215

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Clinical evaluation of drugs used in fertility regulation.