Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00864214 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Evaluation of Bioidentical Compounded Estrogen Cream and Natural Progesterone
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00864214: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT00864214 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00864214, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study 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.
Interventions
- DRUG bioidentical hormone (Biest)
- DRUG bioidentical hormone (Vivelle-Dot)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2008-06 |
| Est. Completion | 2010-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00864214
The ClinicalTrials.gov registry entry for NCT00864214 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which bioidentical hormone (Biest) is the first listed.
NCT00864214 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00864214 about?
NCT00864214 is a clinical study titled "A Pharmacokinetic Evaluation of Bioidentical Compounded Estrogen Cream and Natural Progesterone". 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, Compleme...
What is the current status of trial NCT00864214?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2008-06. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00864214?
The interventions under investigation include: bioidentical hormone (Biest) (DRUG), bioidentical hormone (Vivelle-Dot) (DRUG).
Who is sponsoring clinical trial NCT00864214?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.