A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Evaluate the Safety and Efficacy of Estradiol in Combination with Progesterone in Postmenopausal Women with an Intact Uterus: Estradiol to Reduce the Frequency and Severity of Vasomotor Symptoms and Progesterone to Manage the Incidence of Endometrial Hyperplasia
A study for Menopausal women using an investigational drug TX004-HR to reduce the frequency of hot flushes.
Sponsor: TherapeuticsMD
Enrolling: Female Patients Only
Study Length: 14 Months
Clinic Visits: 7
IRB Number: AAAM3602
Contact: Luz Sanabria: 212-305-9672 / ls2328@cumc.columbia.edu
Additional Study Information: The purpose of this study is to evaluate a new experimental (investigational) oral combination hormone drug product containing estradiol (a form of the estrogen) and progesterone (a female hormone that regulates the inner lining of the uterus called the endometrium) for postmenopausal women who have hot flushes. The estradiol and progesterone used in this study are similar to the natural estrogen and progesterone produced by the ovaries prior to menopause. This study will determine the safety of this combination drug and if it works in treating hot flushes (also called "hot flashes") and managing endometrial hyperplasia (the excessive growth of cells in the lining of the uterus).
This study is closed
Rogerio Lobo, MD, FACOG
Do You Qualify?
Are you experiencing moderate to severe hot flashes? Yes No
Are you a postmenopausal women with an intact uterus? Yes No
Are you currently using any hormonal treatments? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Luz Sanabria