A Pharmacokinetic Evaluation of Bioidentical Compounded Estrogen Cream and Natural Progesterone
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.
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.
Study Design
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Menopause
Intervention
bioidentical hormone (Biest), bioidentical hormone (Biest), bioidentical hormone (Biest), bioidentical hormone (Vivelle-Dot)
Location
Mayo Clinic
Rochester
Minnesota
United States
55905
Status
Active, not recruiting
Source
Mayo Clinic
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00864214
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Antineoplastic Agents, Hormonal
Antineoplastic agents that are used to treat hormone-sensitive tumors. Hormone-sensitive tumors may be hormone-dependent, hormone-responsive, or both. A hormone-dependent tumor regresses on removal of the hormonal stimulus, by surgery or pharmacological block. Hormone-responsive tumors may regress when pharmacologic amounts of hormones are administered regardless of whether previous signs of hormone sensitivity were observed. The major hormone-responsive cancers include carcinomas of the breast, prostate, and endometrium; lymphomas; and certain leukemias. (From AMA Drug Evaluations Annual 1994, p2079)
Receptors, Lhrh
Receptors with a 6-kDa protein on the surfaces of cells that secrete LUTEINIZING HORMONE or FOLLICLE STIMULATING HORMONE, usually in the adenohypophysis. LUTEINIZING HORMONE-RELEASING HORMONE binds to these receptors, is endocytosed with the receptor and, in the cell, triggers the release of LUTEINIZING HORMONE or FOLLICLE STIMULATING HORMONE by the cell. These receptors are also found in rat gonads. INHIBINS prevent the binding of GnRH to its receptors.
Human Growth Hormone
A 191-amino acid polypeptide hormone secreted by the human adenohypophysis (PITUITARY GLAND, ANTERIOR), also known as GH or somatotropin. Synthetic growth hormone, termed somatropin, has replaced the natural form in therapeutic usage such as treatment of dwarfism in children with growth hormone deficiency.
Hyperpituitarism
Disease of the glandular, anterior portion of the pituitary (PITUITARY GLAND, ANTERIOR) resulting in hypersecretion of ADENOHYPOPHYSEAL HORMONES such as GROWTH HORMONE; PROLACTIN; THYROTROPIN; LUTEINIZING HORMONE; FOLLICLE STIMULATING HORMONE ; and ADRENOCORTICOTROPIC HORMONE. Hyperpituitarism usually is caused by a functional ADENOMA.
Leuprolide
A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
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