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  • Title: Facts about once-a-month injectable contraceptives: memorandum from a WHO meeting.
    Journal: Bull World Health Organ; 1993; 71(6):677-89. PubMed ID: 8313486.
    Abstract:
    This Memorandum reviews the results of research undertaken in animals and human subjects on once-a-month injectable contraceptives containing a progestogen and an estrogen, in particular the products Cyclofem and Mesigyna. Results from clinical trials, including effectiveness and side-effects, are evaluated and issues arising from health service research are discussed. The Memorandum concludes with a statement regarding the use of Cyclofem and Mesigyna as options for potential contraceptive users. Experts met in June 1993 at WHO headquarters in Geneva to review animal and research findings on once-a-month injectable contraceptives with a progestogen and an estrogen, especially Cyclofem and Mesigyna. Two widely used injectable contraceptives are the Chinese Injectable No. 1 (250 mg 17alpha-hydroxyprogesterone caproate + 5 mg estradiol valerate) and an injectable with 150 mg dihydroxyprogesterone acetophenide + 10 mg estradiol enanthate used in Latin America. Two new combined once-a-month injectables are Cyclofem (25 mg medroxyprogesterone acetate + 5 mg estradiol cypionate) and Mesigyna (50 mg norethindrone enanthate + 5 mg estradiol valerate). The aforementioned doses are based on high efficacy and acceptable vaginal bleeding patterns. Pregnancy life table rates in 5 clinical phase III trials in 9793 women (102,058 woman-months of use) are all below 0.4% for Mesigyna and 0.2% for Cyclofem. More than 65% had normal menstrual cycles. Discontinuations for menstrual irregularities were 50% less than those of progestogen only injectables. Discontinuation rates for amenorrhea were low. The limited data on return to ovulation suggest that ovulation occurs within a few months of discontinuation. No safety concerns have been evident in the animal studies. Long term data on humans on the once-a-month injectables and cancer do not yet exist. The incidence of side effects is low. Studies of Cyclofem in 6 countries with more than 9000 women have examined management and service issues and medical surveillance. Identified needs are adequate patient information, staff trained in new methods, monthly injectables as a free choice of contraceptive methods, proper distribution and storage, and adequate supplies. As long has all potential risk factors are taken into account, Cyclofem and Mesigyna are safe and effective.
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