A Pharmacokinetic Evaluation of Bioidentical Compounded Estrogen Cream and Natural Progesterone
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
Bioidentical compounded hormone therapy (BCHT) is considered a 'safer' option to the
conventional hormones (HT) by its proponents. However, there is limited research data to
support their claims. Our group at the Women's Health Clinic, in collaboration with the
Departments of Endocrinology, Complementary Medicine and Laboratory Medicine, is interested
in developing a line of research to test the safety and efficacy of BCHT. In the present
study, we aim to find the dose of BCHT that is bioequivalent to conventional HT, in a
randomized, blinded, four-arm, phase I clinical trial. We will estimate the levels of estrone
(E1), estradiol (E2) and estriol (E3) at baseline and at steady state with two-weeks of
administration of three commonly used doses of bioidentical compounded estrogen cream (Biest)
and a standard dose conventional estrogen patch (Vivelle-Dot). E1, E2, and E3 values will be
summarized using point estimates and 95% confidence intervals. Two-sample t-test will be used
to compare each Biest group to the Vivelle-Dot group. Healthy postmenopausal women, with no
contraindications for hormone use, who are able to fully understand and participate in the
trial, will be enrolled. We will utilize the resources of Mayo CRU to conduct this study.