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  • Title: New year, new option: Cyclo-Provera awaits word.
    Journal: Contracept Technol Update; 1998 Jan; 19(1):3-4. PubMed ID: 12348212.
    Abstract:
    This article discusses the potential availability of Cyclo-Provera, a monthly injectable similar to Depo-Provera that is being considered for approval by the US Food and Drug Administration (FDA). A new drug application was filed by its marketing company, Pharmacia and Upjohn of Kalamazoo, Michigan, in September 1997. The company wants mutual recognition by the FDA in US and European markets. The Jones Institute for Reproductive Medicine at the Eastern Virginia Medical School in Norfolk recently completed a company-sponsored clinical trial of the drug. This Institute is 1 of 44 sites conducting nationwide clinical trials among a total sample of 1200 women over 5 years. Cyclo-Provera is comprised of depomedroxyprogesterone acetate (DMPA), which is the same ingredient in Depo-Provera. Cyclo-Provera has a lower dose of DMPA (25 mg) combined with 5 mg of estradiol cypionate. The ingredients are expected to provide improved monthly menstrual cycle control. Cyclo-Provera is marketed outside the US under the name Cyclofem. Cyclofem is mainly used in China and Latin America. Germany produces a similar drug. The World Health Organization (WHO) has conducted multinational studies on both drugs. WHO recommends Cyclofem for most women who desire effective, reversible contraception and who are not at risk for most cardiovascular complications. The estrogen in Cyclofem is less potent and has a shorter life span than the estrogen in combined contraceptives. WHO guidelines suggest that Cyclofem has advantages that outweigh disadvantages for smokers under 35 years old, light smokers older than 35, women with mild hypertension (160/100), women with current or medically treated gall bladder disease, or women with mild cirrhosis. Cyclofem is not recommended for heavy smokers over 35 years old, women with a history of hypertension, and women with severe cirrhosis.
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