Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Pharmacokinetic Evaluation of Bioidentical Compounded Estrogen Cream and Natural Progesterone
Brief 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.


Options:
A: Arm Label: Treatment 1; Type: EXPERIMENTAL; Interventions: Drug: Estradiol, Drug: Progesterone, Drug: Placebo | Arm Label: Treatment 2; Type: EXPERIMENTAL; Interventions: Drug: Estradiol, Drug: Progesterone, Drug: Placebo | Arm Label: Treatment 3; Type: EXPERIMENTAL; Interventions: Drug: Estradiol, Drug: Progesterone, Drug: Placebo | Arm Label: Treatment 4; Type: EXPERIMENTAL; Interventions: Drug: Estradiol, Drug: Progesterone, Drug: Placebo | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Estradiol; Assigned to Arm(s): Treatment 1, Treatment 2, Treatment 3, Treatment 4 | Intervention Type: DRUG; Name: Progesterone; Assigned to Arm(s): Treatment 1, Treatment 2, Treatment 3, Treatment 4 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo, Treatment 1, Treatment 2, Treatment 3, Treatment 4
B: Intervention Type: DRUG; Name: estradiol gel; Assigned to Arm(s): N/A
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: bioidentical hormone (Biest) | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: bioidentical hormone (Biest) | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: bioidentical hormone (Biest) | Arm Label: 4; Type: EXPERIMENTAL; Interventions: Drug: bioidentical hormone (Vivelle-Dot) | Intervention Type: DRUG; Name: bioidentical hormone (Biest); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: bioidentical hormone (Biest); Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: bioidentical hormone (Biest); Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: bioidentical hormone (Vivelle-Dot); Assigned to Arm(s): 4
D: Arm Label: Placebo transdermal three 90 μL sprays; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo transdermal three 90 μL sprays | Arm Label: Placebo transdermal two 90 μL sprays; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo transdermal two 90 μL sprays | Arm Label: Placebo transdermal one 90 μL spray; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo transdermal one 90 μL spray | Arm Label: Estradiol transdermal three 90 μL sprays; Type: ACTIVE_COMPARATOR; Interventions: Drug: Estradiol transdermal three 90 μL sprays | Arm Label: Estradiol transdermal two 90 μL sprays; Type: ACTIVE_COMPARATOR; Interventions: Drug: Estradiol transdermal spray, two 90 μL sprays | Arm Label: Estradiol transdermal one 90 μL spray; Type: ACTIVE_COMPARATOR; Interventions: Drug: Estradiol transdermal one 90 μL spray | Intervention Type: DRUG; Name: Estradiol transdermal one 90 μL spray; Assigned to Arm(s): Estradiol transdermal one 90 μL spray | Intervention Type: DRUG; Name: Estradiol transdermal spray, two 90 μL sprays; Assigned to Arm(s): Estradiol transdermal two 90 μL sprays | Intervention Type: DRUG; Name: Estradiol transdermal three 90 μL sprays; Assigned to Arm(s): Estradiol transdermal three 90 μL sprays | Intervention Type: DRUG; Name: Placebo transdermal two 90 μL sprays; Assigned to Arm(s): Placebo transdermal two 90 μL sprays | Intervention Type: DRUG; Name: Placebo transdermal three 90 μL sprays; Assigned to Arm(s): Placebo transdermal three 90 μL sprays | Intervention Type: DRUG; Name: Placebo transdermal one 90 μL spray; Assigned to Arm(s): Placebo transdermal one 90 μL spray

Answer: C