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  • Title: Vaginal bleeding patterns in women using once-a-month injectable contraceptives.
    Author: Fraser IS.
    Journal: Contraception; 1994 Apr; 49(4):399-420. PubMed ID: 8013222.
    Abstract:
    The main raison d'être for the development of once-a-month injectable contraceptives is the need for a long-acting method which produces a regular vaginal bleeding pattern. Although many women will successfully tolerate the amenorrhea or irregular bleeding which frequently accompany use of long-acting progestogen-only methods, there is a substantial minority, especially in certain ethnic groups, who find this unacceptable. The extensive literature does indicate that although combined estrogen-progestogen once-a-month injectables produce much more regular bleeding patterns than long-acting injectables like depot-medroxyprogesterone acetate, the patterns are not entirely normal. Detailed studies by the World Health Organization have demonstrated some deviation from normal menstrual patterns by users of the two once-a-month injectables, Cyclofem and Mesigyna. For example, 23.5% of Cyclofem and 25.2% of Mesigyna users experience irregular bleeding between 3 and 6 months of use compared with 4.8% of untreated women, and 13.3% of Cyclofem and 11.1% of Mesigyna users experience prolonged bleeding compared with 2.3% of untreated women. Comparable figures are much worse for DMPA users with a 35.7% incidence of irregular and 27.7% incidence of prolonged bleeding after similar duration of use. Bleeding patterns with all long-acting methods tend to improve with time. Overall group data for once-a-month injectable users are reasonably close to those of untreated women with, for example, a median of 15.6 days (5th and 95th percentiles: 7.5 and 26; confidence limits) of bleeding or spotting per 90-day reference period compared with a median of 18.5 days (5th and 95th percentiles: 12.2 and 25.5) for untreated women. Twelve-month life table discontinuation rates for menstrual bleeding disturbances are lower than expected for most progestogen-only methods at 2.1-5.2% for Cyclofem and 0.8-4.2% for Mesigyna for amenorrhea, and 6.3-12.7% for Cyclofem and 7.5-12.0% for Mesigyna for bleeding-related reasons. Once-a-month injectable contraceptives produce vaginal bleeding patterns much closer to normal than other injectables, but there are still significant deviations which lead to some discontinuation for menstrual reasons. Hence, full explanation and counselling about possible menstrual changes are still essential for all intending users of these methods. A significant minority of women, particularly those in certain ethnic groups, find unacceptable the amenorrhea or irregular bleeding associated with long-acting progestogen-only injectable contraceptives (e.g., Depo-Provera). Researchers have developed once-a-month injectables to meet the need for a long-acting contraceptive method that effects a regular vaginal bleeding pattern. Even though the considerable data on combined estrogen-progestogen once-a-month injectables show that normal bleeding patterns are more likely with these injectables than those of the long-acting progestogen-only injectables, the vaginal bleeding patterns are not altogether regular. Studies show that users of 2 once-a-month injectables, Cyclofem and Mesigyna, experience bleeding patterns that digress somewhat from normal menstrual patterns. When all data are analyzed, irregular bleeding occurs between 3 and 6 months in 23.5% of Cyclofem and 25.2% of Mesigyna users, while it occurs in just 4.8% of untreated women. Prolonged bleeding is also more common in Cyclofem and Mesigyna users (13.3% and 11.1%, respectively vs. 2.3%). Yet, their irregular and prolonged bleeding rates at 3-6 months are better than those for Depo-Provera (35.7% and 27.7%, respectively). Bleeding patterns tend to become less frequent over time with all long-acting methods, however. Women using once-a-month injectables tend to have bleeding or spotting as many days in a 90 day reference period as do untreated women (median, 15.6 vs. 18.5). Researchers find lower 12-month life table discontinuation rates for menstrual disturbances for Cyclofem (2.1-5.2% for amenorrhea and 6.3-12.7% for bleeding related reasons) and Mesigyna (0.8-4.2% for amenorrhea and 7.5-12% for bleeding related reasons) than expected for most progestogen-only methods. Despite improved vaginal bleeding patterns, providers need to provide potential users of once-a-month injectables with a full explanation and counseling about possible vaginal bleeding patterns.
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