Seventy percent of menopausal women experience climacteric symptoms. Since the publication of the Women's Health Initiative Estrogen/Progestin Clinical Trial (2002), prescriptions of hormonal therapies have decreased significantly, leaving patients suffering with symptoms, often leading to a reduced quality of life.
This controlled, clinical trial was conducted by 90 gynecologists on 324 peri- and postmenopausal subjects using a non-hormonal treatment, Relizen®, for 3 months. The subject's climacteric symptoms were assessed over time: hot flashes, sweating, fatigue, irritability, quality of sleep, quality of life by visual analogue scales and specific questions using baseline scores as reference. Study subjects took 2 tablets/day during the 90 days of observation. Assessments of the patients/symptoms were made at Day1 and Day89.
There were no significant differences between the perimenopausal and menopausal groups at baseline. For the 324 study subjects, 85.5% and 91% of the women had an improvement in their hot flash frequency and severity, respectively. On the 100 mm VAS, a mean decrease of 41.7±23.6 (P<.0001) for frequency and 45.8±23.0 (P<.0001) for severity of hot flashes was demonstrated. Over 60% of the women had a significant improvement (P<.0001) in irritability (from 41.8±31.5 to 16.5±20.0) and fatigue (from 45.5±31.2 to 19.8±22.4). Monitored parameters were significantly improved leading to a 70% improvement in quality of life scores, in 71.9% of the subjects. All the treatments were well tolerated.
Relizen®, a non-hormonal treatment option, exhibited significant efficacy and safety on climacteric symptoms in both peri- and postmenopausal women.
George Washington University School of Medicine, Washington, DC
Financial Disclosure: Dr. Simon (George Washington University School of Medicine) disclosed the following—JDS Therapeutics: Consultant/Advisory Board; Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support. Dr. Druckman (Professor, ANEMO Menopause Center) disclosed the following—JDS Therapeutics: Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support.