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Ulipristal acetate tops placebo for uterine leiomyomas

Key clinical point: For women with symptomatic uterine leiomyomas, ulipristal at either 5 mg or 10 mg significantly improved both the rate of and time to amenorrhea, compared with placebo.

Major finding: Patients who received 5 or 10 mg ulipristal showed significant improvements in Uterine Fibroid Symptom Health-Related Quality of Life scales, compared with those who received placebo (P less than .001).

Study details: VENUS I and II, 12-week randomized controlled trials of ulipristal acetate or placebo in 589 women with symptomatic uterine leiomyomas and abnormal uterine bleeding.

Disclosures: Allergan provided funding. Dr. Lukes disclosed ties to Allergan, AbbVie, Myovant, Merck, and several other companies. Four of the coauthors are employees of Allergan, and the two remaining coauthors had links to a number of pharmaceutical companies.


Lukes AS et al. Obstet Gynecol. 2019 May;133(5):869-78.


In this study, 77%-87% of women who received ulipristal acetate reported more than a 20-point improvement in health-related quality of life, compared with only 36% of placebo recipients, Joanna L. Hatfield, MD, wrote in an accompanying editorial.

“However, women with leiomyomas report a 51-point mean improvement after hysterectomy,” she noted. “Clinicians need to keep this difference in mind when counseling women with leiomyomas.”

Ulipristal can cause fatigue and weight gain leading to treatment discontinuation, she noted. Very rare cases of liver failure also have been reported, and there is no evidence that liver enzyme screening identifies patients at risk.

Nonetheless, for the approximately half of women with symptomatic leiomyomas who desire uterine-sparing treatment, selective progesterone receptor modulators like ulipristal offer “a noninvasive way to manage bleeding and bulk symptoms,” Dr. Hatfield said.

She advocated for long-term safety studies and a large pregnancy registry, calling ulipristal “neither a panacea nor a Pandora’s box,” but a choice that “lies somewhere in the middle, just [like] nearly all options that present themselves in a woman’s life.”

Dr. Hatfield is director of the fibroid program at Oregon Health & Science University in Portland. She did not report having conflicts of interest. She wrote an editorial accompanying the article by AS Lukes et al. (Obstet Gynecol. 2019 May;133[5]:867-8).