WASHINGTON — A 0.45-mg daily dose of synthetic conjugated estrogens-A improves moderate to severe menopausal vasomotor symptoms, compared with placebo, according to data presented at the annual meeting of the American College of Obstetricians and Gynecologists.
The results indicate that postmenopausal women who start estrogen therapy at a low dose may be able to gain the efficacy of higher-dose treatments while having minimal side effects, Dr. James A. Simon of George Washington University in Washington and Dr. Sam S. Miller of the SAM Clinical Research Center in San Antonio wrote in a poster presented at the ACOG meeting.
At week 12 of therapy, nearly 38% of patients taking synthetic conjugated estrogens-A (SCE-A) reported no moderate to severe vasomotor symptoms vs. 7.8% of patients taking placebo, according to the researchers. In addition, the 0.45-mg daily dose of SCE-A reduced the mean weekly frequency of moderate to severe vasomotor symptoms by 67.8 from a baseline of 95.9 at 12 weeks, compared with a mean drop of 42.9 among placebo patients from the same baseline score.
The multicenter, double-blind trial included postmenopausal women, with or without a uterus, who had experienced at least 60 moderate to severe vasomotor symptoms per week. A total of 104 patients were randomized to receive either the 0.45-mg dose of SCE-A or placebo daily for 12 weeks. Approximately 91% of the patients taking SCE-A and 67% of the patients taking placebo completed the full 12 weeks of the study.
The subjects were asked to keep a daily diary of the frequency and severity of their symptoms. Patients also had vital signs, body weight, and adverse events evaluated during six office visits. The investigators assessed the safety and tolerability of the treatment through standard laboratory evaluations at screening and at week 12 of the study.
The research was supported by Duramed Research Inc. of Bala Cynwyd, Pa., which markets SCE-A under the trade name Cenestin. Duramed is a wholly owned subsidiary of Barr Pharmaceuticals. Cenestin 0.45 mg was approved by the Food and Drug Administration in 2004 for the treatment of moderate to severe vasomotor symptoms. The patients recruited for the study were healthy women ages 30–80 years who had experienced spontaneous amenorrhea for 12 months before screening or had a bilateral oophorectomy, with or without hysterectomy, at least 6 weeks before screening.
Patients taking SCE-A had a greater reduction in frequency of symptoms starting at week 2 and reaching statistical significance from week 3 on. The drug also resulted in greater reduction in severity of symptoms at week 2, reaching statistical significance from week 5 on.