Efficacy Study Comparing 0.9 g and 1.25 g Estrogel With Placebo for Vasomotor Symptoms and Vulvar and Vaginal Atrophy

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ASCEND Therapeutics
• Collaborator: Solvay Pharmaceuticals
• Treatments: Estradiol

Criteria

Inclusion Criteria:

• Women 45-65 years

• naturally or surgically postmenopausal

• experiencing hot flushes

Exclusion Criteria:

• hypersensitivity to estrogen replacement therapy

• pregnancy or lactating

• abnormal PAP smear

• history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy