Norethindrone effectively treats bothersome bleeding for women using etonogestrel implants
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Key takeaways :
- A total of 80% of women who received the norethindrone implant had a satisfactory bleeding pattern.
- No women who received the norethindrone implant requested removal due to bothersome bleeding.
BALTIMORE — A novel etonogestrel drug implant demonstrated effectiveness in treating bothersome bleeding for women using etonogestrel implants for contraception, researchers reported.
An etonogestrel drug implant (Nexplanon, Organon) is an effective and implantable subdermal contraceptive that releases progestin over 3 years to suppress ovulation and thicken the cervical mucus, according to the researchers.
“There are several regimens [to treat bothersome bleeding] that have previously been studied in clinic, such as hormones, anti-inflammatory and prostaglandin medications,” Jordan Gray, MD, resident physician at the Baylor Scott & White Medical Center in Temple, Texas, told Healio. “An ideal intervention would be readily available, inexpensive, have minimal to no side effects and will be simple to implement by the etonogestrel drug implant user.”
This randomized, double-blind, placebo-controlled trial, included 51 participants aged either 18 to 48 years or 14 to 17 years who wanted an etonogestrel drug implant for contraception. Participants were randomly assigned to norethindrone 5 mg or placebo daily for 1 week every 4 weeks for 6 months.
The primary outcome was excessive bleeding, which was defined as greater than seven consecutive days of bleeding or spotting.
Overall, 80% of participants who received the norethindrone implant reported a satisfactory bleeding pattern. No participants who received the norethindrone implant requested removal due to bothersome bleeding compared with 20.69% of participants who received placebo. In addition, 24% of women who received the placebo requested removal at or before completion of 6 months for various reasons, including bothersome bleeding.
Overall, 45.45% of participants who received the norethindrone implant requested early removal due to reasons other than bothersome bleeding, such as wanting to get pregnant or noncompliance with the study parameters. Only one woman who had the norethindrone implant reported unsatisfactory amenorrhea.
“Our data suggests that this regimen is simple and an acceptable method to treat bothersome bleeding and that predictable bleeding is maybe more satisfactory than unpredictable bleeding,” Gray said. “We warrant further study, and we think that our data can further future studies. But, in the meantime, we can also use this as an FDA approved medication to continue, not for this indication, but as a medication that's used commonly to continue to help with bothersome bleeding.”