Is there scientific evidence for Clevatess?

Is there scientific evidence for Clevatess?

Yes, there is substantial scientific evidence for Clevatess (conjugated estrogens/bazedoxifene), which has undergone rigorous clinical testing to demonstrate its safety and efficacy for treating menopausal symptoms.

Clinical Trial Foundation

Clevatess is backed by extensive clinical research, including the landmark SMART (Selective estrogens, Menopause, And Response to Therapy) trials. These Phase III studies involved over 7,000 postmenopausal women and evaluated the medication's effectiveness in treating moderate to severe hot flashes and preventing osteoporosis.

Key Research Findings

The clinical evidence demonstrates that Clevatess significantly reduces the frequency and severity of hot flashes compared to placebo. In pivotal studies, women experienced a meaningful reduction in weekly hot flash frequency as early as week 4 of treatment, with continued improvement over 12 weeks.

For osteoporosis prevention, research shows Clevatess helps maintain bone mineral density at the lumbar spine and hip, crucial areas for fracture prevention in postmenopausal women.

Safety Profile Evidence

Long-term safety studies spanning up to two years have established Clevatess's cardiovascular and breast safety profile. The bazedoxifene component acts as a selective estrogen receptor modulator (SERM), providing estrogen's benefits while blocking unwanted effects on breast and uterine tissue.

Regulatory Approval

The robust scientific evidence led to FDA approval in 2013, making Clevatess the first tissue selective estrogen complex (TSEC) available for treating menopausal symptoms. The approval was based on comprehensive data showing both efficacy and an acceptable safety profile.

This extensive research foundation makes Clevatess a well-studied option for women seeking relief from menopausal symptoms. If you're considering hormone therapy, discussing this evidence-based treatment with your healthcare provider can help determine if it's right for your specific situation.