To investigate the long-term efficacy and safety of ERr 731 in perimenopausal women with menopausal symptoms.
This was a multicenter, prospective, 48-week observational study (OS) (OS I) followed by a 48-week OS II in perimenopausal women with menopausal symptoms taking ERr 731. Of 109 women participating in a previous randomized, placebo-controlled trial (RCT), 39 women receiving ERr 731 and 41 women receiving placebo participated in OS I. Fifty-one women continued to take ERr 731 in OS II (23 women from the ERr 731 group and 28 women from the placebo group). The primary outcome criterion for long-term efficacy of ERr 731 was the change in the Menopause Rating Scale II score after 48 and 96 weeks. Several efficacy and safety parameters were also assessed.
Women in the ERr 731 group in the RCT experienced a further decrease in their symptoms during OS I. Women who received placebo during the RCT and started taking ERr 731 in OS I reported a significant decrease in menopausal symptoms. After 18 weeks in OS I, their symptom scores were comparable to those of women who had taken ERr 731 for 12 weeks during the RCT. The symptom scores further decreased slightly in all women during OS II. At the end of OS II, all women had on average less than 1.4 slight hot flushes per day. There was no clinically relevant change in safety parameters, and no adverse events were observed with relation to the long-term use of ERr 731.
ERr 731 is effective and safe in the long-term treatment of menopausal symptoms in perimenopausal women.
A decrease in climacteric complaints, a high satisfaction with treatment, and no unwanted side effects by an up to 2 year intake of ERr 731 were shown confirming that ERr 731 can be effective and safe.
From the 1Health Research Services Ltd., St. Leon-Rot, Germany; 2Department of Obstetrics and Gynecology, National Medical University A.A. Bogomolets, Kiev, Ukraine; 3Chemisch-Pharmazeutische Fabrik Goeppingen, Carl Mueller, Apotheker, GmbH u. Co. KG, Goeppingen, Germany; and 4Internal Medicine, University of New Mexico, Albuquerque, NM.
Received April 7, 2008; revised and accepted May 20, 2008.
Financial disclosure: None reported.
Address correspondence to: Marietta Kaszkin-Bettag, PhD, Health Research Services Ltd., Opelstr. 8a, 68789 St. Leon-Rot, Germany. E-mail: firstname.lastname@example.org