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13 recordsLinked to original sources
PubMed1994

Menstrual impact of contraception.

Persistent bleeding is a common reason for the discontinuation of contraception. Standard terminology for describing bleeding patterns by reference period is presented. Observed bleeding patterns with oral contraceptives, depot medroxyprogesterone acetate, the levonorgestrel subdermal implant, and intrauterine devices are described. Bleeding days are least with oral contraceptives that are highest in progestin and estrogen potency and dose, but the ratio of the two steroids is also important. Published studies suggest that oral contraceptives containing new nonandrogenic progestins have bleeding patterns as acceptable as older low estrogen formulations. Approaches to the evaluation and treatment of intermenstrual bleeding with contraceptive methods are reviewed. Patient education on expected bleeding patterns is essential to compliance and continuation.

Contraceptive Agents↗
PubMedDate not supplied

Early symptoms and discontinuation among users of oral contraceptives in Sri Lanka.

The relationship between symptoms reported during the first two cycles of oral contraceptive use and subsequent discontinuation was studied using data from a comparative clinical trial of two oral contraceptives (standard dose and low dose) in Sri Lanka. Among 24 symptoms considered, the most commonly reported were headache, nausea, irritability, dizziness, tiredness, intermenstrual spotting/bleeding, backache, abdominal pain, vomiting, and hair loss. Headache, nausea, vomiting, and dizziness were closely associated with each other and strongly predictive of discontinuation for both drugs. No other symptoms were consistently associated with each other or with subsequent discontinuation. Intermenstrual spotting/bleeding was associated with later discontinuation of the standard dose preparation, but not the lower dose preparation.

Adolescent↗
PubMed1991

Interchangeability of low-dose oral contraceptives. Are current bioequivalent testing measures adequate to ensure therapeutic equivalency?

Current Food and Drug Administration guidelines for assessing the differences in bioavailability between generic oral contraceptives and brand-name products are inadequate to ensure therapeutic equivalence. The guidelines do not take into account those women who may have blood levels of active ingredients well outside the range of acceptability. Due to the narrow therapeutic range of steroids, these women may become pregnant or experience an increased incidence of breakthrough bleeding. Furthermore, oral contraceptive packaging is unique to each manufacturer, and any change in brands (and therefore packaging) can easily negate the sequential administration of the appropriate tablet. These are among the reasons proposed for placing oral contraceptives in the critical drug category, in which generic substitution and interchangeability of products should not be allowed.

Biological Availability↗
PubMed1989

Guidelines and requirements for the evaluation of contraceptive steroids.

Since their introduction in the early 1960s, the oral contraceptive (OCs) steroids have been subjected to preclinical and clinical investigations unprecedented in medical history. As a result of such extensive studies, it is now possible to make a comprehensive review of preclinical and clinical data on oral contraceptives. The OCs were introduced at a time when the Food and Drug Administration (FDA) was undergoing drastic changes as a result of the thalidomide tragedy, the introduction of the Kefauver-Harris Amendment, and the desire for greater control over the pharmaceutical industry. The initial requirements for the safety evaluation of OCs were identical to those of other drugs. There were no explicit requirements for OCs although it was generally felt that the requirements should be more stringent because the OCs were being used in otherwise healthy women for long periods of time and with minimal medical supervision. In the 1960s when it became apparent from ongoing studies that there was an increased incidence of mammary tumors in dogs treated with some progestins, the FDA made the decision to terminate clinical studies and established the requirement for 7- and 10-yr studies in dogs and monkeys, respectively. The primary purpose of this paper is to present an historical perspective of the evolution of the preclinical requirements for the evaluation of the safety of OCs prior to their use in the various phases (I, II, III) of clinical trials. Some proposed changes in the requirements are discussed. This information will form the basis for other presentations dealing with the safety assessment of OCs in rats, dogs, and monkeys.

Animals↗
PubMed1984

Canadian regulation of contraceptive devices.

Widespread use and technical developments associated with oral contraceptives (OCs), IUDs, techniques involved with abortion, and laparoscopy have resulted in hazards which require governmental control. The objectives and regulatory aspects of contraceptive devices undertaken by the Bureau of Medical Devices is described. The development of quality standards, both voluntary and regulatory, and the importance of postmarket controls for contraceptive devices are recent developments designed to ensure improvement in the health of the Canadian public. New and developing contraceptive device technology may have profound effects on the health and wellbeing of the Canadian public. The challenge of ensuring the safety and efficacy of contraceptive devices must be better met by communication from those patients who are affected. Physician and other allied health professionals who interface with the patient must be sensitive to the concerns of the patients.

Americas↗