Trial Information

Summary: A Phase IV efficacy and safety study of an already approved investigational drug versus placebo in reducing the frequency and severity of moderate to severe hot flashes in 30 - 80 year old menopausal women.

A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial to Demonstrate the Safety and Efficacy of Daily 0.3 mg Synthetic Conjugated Estrogens for the Treatment of Vasomotor Symptoms in Postmenopausal Women

A 16 week, 6 visit study to evaluate the efficacy and safety of an already approved investigational drug versus placebo in reducing the frequency and severity of moderate to severe hot flashes.

Patient Inclusion Criteria:

• Healthy women 30 to 80 years of age
• Naturally or surgically menopausal
• With or without a uterus Experiencing 7 daily or 50 weekly moderate to severe hot flashes

Patient Exclusion Criteria:

• Sensitivity to natural or synthetic hormones
• Uncontrolled or insulin-requiring diabetes
• History of heart disease or failure, stroke, undiagnosed chest pains, blood clots in legs
• Chronic hypertension not adequately controlled by medication
• History of breast or endometrial cancer

Primary Outcomes:
The reduction in the frequency and average severity of MSVS from baseline to Week 4 and Week 12

Key Secondary Outcomes:
The reduction in the frequency and average severity of MSVS at each week during the double-blind treatment phase.
The reduction in average severity of VS at each week during the double-blind phase.
An assessment of the proportion of patients in each treatment group who have complete elimination of VS at Week 12 of the double-blind phase.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.