Changes in bleeding patterns with depot medroxyprogesterone acetate subcutaneous injection 104 mg.

OBJECTIVE

This study aims to assess changes in bleeding patterns with the use of depot medroxyprogesterone acetate (DMPA) 104 mg/0.65 ml subcutaneous injection (DMPA-SC 104).

STUDY DESIGN

An analysis was conducted using data from two 1-year, noncomparative clinical trials (N=1787) and a 2-year randomized study comparing DMPA-SC 104 (N=266) with DMPA intramuscular injection (DMPA-IM). Bleeding was analyzed per 30-day interval by category and number of days. Analyses also were performed for age and body mass index (BMI) subgroups and for the percentages of women shifting from bleeding/spotting to amenorrhea after each injection.

RESULTS

Each study showed decreased incidence of irregular bleeding and increased amenorrhea with continued use of DMPA-SC 104. Rates of amenorrhea at Month 12 (52-64% across studies) and Month 24 (71% in the 2-year trial) were comparable with those originally reported for DMPA-IM. Changes in bleeding patterns showed no consistent differences according to age or BMI. The percentages of subjects shifting from bleeding and/or spotting to amenorrhea increased with each subsequent injection.

CONCLUSION

Clinical data show that the incidence of amenorrhea increases over time with the use of DMPA-SC 104.