A Pharmacokinetic Evaluation of Bioidentical Compounded Estrogen Cream and Natural Progesterone
Condition: Menopause
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      This study is designed as a Phase I, blinded, randomized, four-arm clinical trial.
      Participants will be randomized to one of the four interventions: Biest transdermal cream 2.0
      mg/0.5 g daily, Biest 2.5 mg/0.5 g daily, Biest 3.0 mg/0.5 g daily or Vivelle-Dot patch 0.05
      mg/24 hours changed biweekly. Serum levels of E1, E2, E3 and progesterone will be obtained at
      baseline before starting the intervention and then multiple times on days 1 15 and 16 of
      study, as outlined in the table below (Table 3.1). The peak and steady state concentrations
      of E1, E2 and E3, along with time to reach the peak levels, and area under the curve will be
      calculated. Baseline and steady state levels of progesterone will also be compared between
      the compounded and micronized progesterone groups. If there are abnormalities in estrogen
      levels or symptoms suggesting such, a vaginal ultrasound would be done to exclude possible
      ovarian activity as a source.
    

Intervention name(s): bioidentical hormone (Biest); bioidentical hormone (Biest); bioidentical hormone (Biest); bioidentical hormone (Vivelle-Dot)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Estrogen is the Biest 2.0 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg; Estrogen is the Biest 2.5 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg; Estrogen is the Biest 3.0 mg bioidentical cream; the placebo is the transdermal patch; the progesterone is compounded progesterone-100 mg; Estrogen is the Vivelle-Dot patch 0.05 mg; the placebo is the transdermal cream; the progesterone is micronized progesterone-100 mg
Intervention MeSH terms: Hormones; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bioidentical hormone; menopause; estrogen; progesterone