麻豆传媒

BALTIMORE -- The levonorgestrel 52-mg intrauterine device (IUD; Mirena) decreased blood loss by more than 90% for women with heavy menstrual bleeding, an open-label phase III trial showed.

Among 89 women, the median percentage decrease in blood loss for those with follow-up bleeding evaluations was 93.3% by cycle 3 and 97.6% by cycle 6, reported Mitchell D. Creinin, MD, of the University of California Davis in Sacramento, during the American College of Obstetricians and Gynecologists (ACOG) annual meeting.

Treatment success -- defined as the proportion with a final measured blood loss less than 80 mL and at least 50% reduction from baseline -- occurred in 91% of women, and did not vary by body mass index (BMI) or parity.

Both participants with and without obesity had similar median decreases in blood loss (97.5% and 97.6%, P=0.89). There were also comparable findings for nulliparous and parous participants (97.0% and 98.1%, P=0.43).

Of the participants with a BMI of 35 or higher, there was a treatment success rate of 88.1% compared with 93.6% in the ≤35 BMI group. Nearly all nulliparous women had treatment success (96.4%) compared with 88.5% of parous women.

"The key takeaways are pretty significant and rapid decrease in uterine bleeding after levonorgestrel 52-mg IUD in patients with heavy menstrual bleeding and the benefit was similar in nulliparous and parous patients, as well as patients with and without obesity," Creinin said.

The study was also published in .

While two levonorgestrel 52-mg IUDs are currently marketed in the U.S., only Mirena is currently approved by the FDA for treatment of heavy menstrual bleeding, specifically in patients "."

"This approval was granted based on a clinical trial in parous patients with body mass indexes ... of 35 or lower and those desiring the IUD for contraception," Creinin and team wrote. "We lack rigorous data with quantitative blood-loss measurements of treatment outcomes in patients with higher BMIs, nulliparous patients, and patients not desiring the IUD for contraception."

During his ACOG presentation, Creinin noted that bleeding changes have substantial effects on patients' quality of life.

Participants' subjective assessments indicated that heavy bleeding, cramping, and menstruation interfering with their life and sleep were significantly lower at 3 and 6 months compared with baseline.

"We can tell 80% of patients that they are going to have a very significant change in their bleeding profile in a very positive way," Creinin said.

This study was conducted at 29 sites in the U.S. from October 2018 to December 2020. The researchers enrolled 105 participants (mean age 35.4, 65% white, 23.8% Black) with no pelvic or systemic pathology causing heavy menstrual bleeding. Of this group, 44.8% had obesity, and 27.6% were nulliparous. Baseline mean blood loss ranged from 73 to 520 mL (median 143 mL, interquartile range 112–196 mL).

All participants received specific menstrual products to use and recorded their experiences in an e-diary. After using the products, they were brought to follow-up appointments, which occurred within 5 days following the end of the cycle. The used menstrual products were then examined with alkaline hematin testing. The researchers also obtained a serum sample for alkaline hematin blood-loss calculations.

After the participants had an IUD inserted, they were followed for six 28-day cycles. The same initial blood loss assessments were performed in cycles 3 and 6. At cycles 3 and 6, 89 and 81 participants provided bleeding outcomes, respectively, with 89 providing at least one follow-up cycle for evaluation of the primary outcome.

At the end of the study, participants could keep their IUD or have it removed.

Although study participants were provided menstrual products for consistency, they sometimes used outside products, which Creinin and team noted was a limitation to their study.

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