Bleeding patterns of women using Lunelle monthly contraceptive injections (medroxyprogesterone acetate and estradiol cypionate injectable suspension) compared with those of women using Ortho-Novum 7/7/7 (norethindrone/ethinyl estradiol triphasic) or other oral contraceptives |
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Authors: | Garceau R J,Wajszczuk C J,Kaunitz A M Lunelle Study Group |
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Affiliation: | a Pharmacia Corporation, 7000 Portage Road, Kalamazoo, MI 49001 USA b Department of Obstetrics and Gynecology, University of Florida Health Science Center, Jacksonville, FL, USA |
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Abstract: | Persistent and/or unpredictable bleeding is a common reason for discontinuation of hormonal contraceptive methods. An open-label, nonrandomized, parallel, controlled study compared the efficacy, safety, and cycle control of the new, highly efficacious monthly injectable contraceptive containing 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate (E2C) (MPA/E2C) (Lunelle™ Monthly Contraceptive Injection) with that of the frequently used norethindrone 0.5, 0.75, 1.0 mg/0.035 mg ethinyl estradiol (NET/EE) triphasic oral contraceptive (Ortho-Novum® 7/7/7). This report directly compares the bleeding patterns of women on MPA/E2C to those of women on NET/EE and untreated women. Overall, breakthrough bleeding occurred less frequently in women using MPA/E2C than in women using NET/EE (p ≤0.01). However, more women using MPA/E2C experienced amenorrhea/missed periods than those on NET/EE (p ≤0.01). In addition, the percentage of women experiencing breakthrough bleeding or amenorrhea while using other oral contraceptives is compared to that of women using MPA/E2C. A rapidly reversible method, MPA/E2C, combines the high contraceptive efficacy of surgical sterilization with the convenience of monthly administration. These data suggest that, for a large proportion of women, MPA/E2C offers predictability in bleeding patterns comparable to or greater than that experienced by ovulatory untreated women or those using combination oral contraceptives. |
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Keywords: | LUNELLE™ Estradiol cypionate Medroxyprogesterone acetate Monthly injectable contraception Ortho-Novum® 7/7/7 Oral contraceptive Breakthrough bleeding Withdrawal bleeding |
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