The effect of a single-dose of a combination injectable contraceptive for treatment of bothersome uterine bleeding in contraceptive implant(s) users; a randomized double-blind placebo-controlled trial.

OBJECTIVE: To determine the proportion of participants whose uterine bleeding/spotting was interrupted for at least seven days during the month after they received a combined hormonal injection. We also evaluated bleeding at 21 days and 12 weeks after the injection.

STUDY DESIGN: We conducted a randomized, double-blind, placebo-controlled trial in 46 contraceptive implant users who presented with bothersome uterine bleeding/spotting. A single dose of a combination injectable contraceptive or placebo was administered intramuscularly at enrollment. Follow-up visits were conducted during the 1st, 4th, and 12th weeks after the treatment.

RESULTS: The proportions of participants whose uterine bleeding/ spotting was interrupted for at least seven days the month after they received a combined hormonal injection were higher in the combination injectable contraception group than in the placebo group (87% vs. 48%, p = 0.005). Participants who reported that they were bleeding-free at 21 days after treatment were 52% and 35% in the combination injectable contraception group and placebo group (p = 0.24). At 12 weeks post-treatment, 17% of participants in the combination injectable contraception group and 4% in the placebo group reported cessation of bleeding with no recurrence (p = 0.34). Median days until first bleeding interruption was shorter in the combination injectable contraception group compared with the placebo group (1 (IQR, 1-2) VS 8 (IQR, 1-28), p = 0.007). Moreover, participants in the combination injectable contraception group experienced fewer days of bleeding during subsequent episodes (7 days VS 8 in the first episode, and 2 days VS 6 in the second episode). Additionally, they had longer bleeding-free intervals in each episode (20 days VS 16 in the first episode and 36 days VS 9.5 in the second episode).

CONCLUSION: The combination injectable contraception interrupted bothersome uterine bleeding/spotting in contraceptive implant(s) users compared with placebo. However, this effect was limited only within the month when the treatment was administered.

IMPLICATION: Bothersome uterine bleeding/spotting is a common side effect leading to contraceptive implant(s) discontinuation. In implant users experiencing these symptoms with no estrogen contraindications, a combined injectable contraception appears to rapidly improve bleeding for the duration of injectable exposure (one month).