Contraceptive Steroids

1. Front Matter

   Pages i-xiii

   PDF

2. Opening Remarks

   1. Opening Remarks

      • Solomon Sobel, William Andrews

      Pages 1-2

3. Oral Contraceptives and the Occurrence of Disease: Clinical Overview

   1. Oral Contraceptives and the Occurrence of Disease

      • Bruce Stadel

      Pages 3-41

4. Comparative Metabolism, Pharmacokinetics and Pharmacology of Steroid Contraceptives

   1. Front Matter

      Pages 43-45

      PDF

   2. The Role of Pharmacokinetics in Preclinical Safety Studies of Synthetic Sex Steroids

      • Michael Humpel, B. Dusterberg, S. Beier, J. Schuppler, P. Gunzel, W. Elger

      Pages 47-65

   3. Pharmacokinetics of Contraceptive Steroids in Humans

      • Uwe Goebelsmann

      Pages 67-111

   4. Species Differences in Metabolism of Contraceptive Steroids

      • Kenneth Fotherby

      Pages 113-122

   5. Steroids of One Class Can Mimic, Inhibit and Potentiate the Biological Effects of Other Steroid Classes When Administered at High Doses

      • C. Wayne Bardin, Olli A. Janne

      Pages 123-143

   6. Mechanism of Action of Estrogen and its Relationship to Toxicological Assessment

      • James H. Clark

      Pages 145-161

   7. Endocrine Effects of Systemic, Steroidal Contraceptives

      • Richard A. Edgren

      Pages 163-178

   8. Hepatotoxicity of Oral Contraceptives

      • Kamal Ishak

      Pages 179-201

   9. New Steroidal Contraceptives, Implications for Toxicological Models

      • Gerhard Zbinden

      Pages 203-210

   10. Summary

       • Egon Diczfalusy

       Pages 211-212

5. Contraceptive Steroids and Carcinogenicity

   1. Front Matter

      Pages 213-213

      PDF

   2. Steroids and Carcinogenesis

      • Mortimer B. Lipsett

      Pages 215-229

   3. An Assessment of the Toxicological and Carcinogenic Hazards of Contraceptive Steroids

      • Ralph Heywood

      Pages 231-245

   4. Estrogens and Carcinogenicity: An Overview of Information from Studies in Experimental Animal Systems

      • Benita S. Katzenellenbogen

      Pages 247-264

   5. A Twenty Year Summary of FDA Animal Safety Testing of Contraceptive Steroids

      • Solomon Sobel

      Pages 265-267

6. Effects of Contraceptive Steroids on Coagulation and Lipid Metabolism

   1. Front Matter

      Pages 269-269

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   2. Introduction

      • Heinz Berendes

      Pages 271-272

One of the United States Food and Drug Administration's most difficult tasks is the assessment of risk-benefit ratios for a broad spectrum of therapeutic and prophylactic drugs. Furthermore, it is now widely recog­ nized that no drug, chemical or even natural substance is completely devoid of risk. Nowhere has this issue been the subject of more controversy than with steroidal contraceptive drugs. Regulated as a special class of products because of their prophylactic use in healthy individuals for prevention of pregnancy rather than for treatment of disease, steroid contraceptives drugs undergo more extensive animal safety tests than any other pharmaceutical agent. This view also contemplates the availability of alternative contraceptive measures posing fewer risks, but the use of less effective methods must take into consideration the hazards associated with pregnancy itself. In April 1983, the Food and Drug Administration and the National Insti­ tutes of Health in cooperation with the World Health Organization, the Population Council, and the Agency for International Development sponsored a three-day workshop to evaluate current guidelines for preclinical safety studies of contraceptive drugs in light of our extensive knowledge of the side effects of marketed products. The meeting included presenta­ tions by experts in the fields of comparative metabolism, pharmacokinetics, pharmacology, carcinogenicity, toxicology, coagulation, lipid metabolism, epidemiology and pathology at a meeting of the Fertility and Maternal Health Drugs Advisory Committee of the National Center for Drugs and Biologics, Food and Drug Administration.

• Lipoprotein
• World Health Organization
• assessment
• drug
• kinetics
• lipide
• metabolism
• pharmacokinetics
• pharmacology
• research
• steroids
• toxicity
• Tree Biology

• Food and Drug Administration, RockVille, USA

  A. T. Gregoire

• National Institutes of Health, Bethesda, USA

  Richard P. Blye

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