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Femhrt Users Report Less Breakthrough Bleeding than Prempro Users: Presented at NAMS

By Denise Mann
Special to DG News

CHICAGO, IL -- October 2, 2002 -- Use of femhrt (1 mg norethindrone acetate/5 µg ethinyl estradiol tablets) results in significantly less bleeding episodes than Prempro (0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate), according to a head-to-head comparison study.

The results were presented here October 3rd at the 13th annual meeting of the North American Menopause Society in Chicago, Illinois, United States.

In the 16-week, open-label, randomised, parallel-group, multicentre study, 240 women were treated with femhrt and 251 with Prempro. Study subjects were aged 45 to 65 years, had an intact uterus, and had been amenorrhoeic for at least six months. Bleeding was defined as any episode requiring the use of a sanitary napkin or pad. Subjects were evaluated for bleeding episodes every at four week intervals.

The researchers analysed the data using the modified intent-to-treat population with the last observation carried forward and controlled for site, smoking status, and time since last menstrual period. Demographic factors and incidence of associated adverse events were similar in the two treatment groups.

Results show that nearly 90 percent of femhrt users did not experience any bleeding episodes during weeks 9 through12, compared with 76 percent of 251 Prempro users (p<0.01). During weeks 13 through 16, about 91 percent and 79 percent of women in each group reported bleeding episodes, respectively (<0.001).

The study also found that femhrt users were more satisfied with their treatment overall and that the impact of bleeding episodes on quality of life is significantly less for women taking femhrt than for those taking Prempro.

"Femhrt has a quantity of progestogen (1 mg of norethindrone acetate) that causes endometrial atrophy, and atrophic endometriosis doesn't bleed," said affiliated researcher James A. Simon, MD, clinical professor at George Washington University, in Washington, DC, and medical director, Women's Health Research Center, in Laurel, Maryland, United States. "No one likes to bleed after menopause. Once a woman stops having her period, she doesn't want it back," he says.

In light of the recently halted Women' Health Initiative (WHI), which looked at Prempro, "there is no question that women will be switching from Prempro to something else, which could be going off [HRT] entirely, so alternative products are not only available, but more will become available," he says.

The study was supported by Pfizer Pharmaceuticals group.

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