NCT00302731

Prospective Double Blind Evaluation of Bioidentical Hormones

Terminated Phase 2 Results posted Last updated 6 June 2018

What this trial tests

Phase 2 trial testing Estradiol , estriol , progesterone in Menopause in 21 participants. Terminated before completion.

Timeline

1 February 2006

Primary endpoint
1 January 2014

1 September 2014

Quick facts

Lead sponsor	Jeanne Drisko, MD, CNS, FACN
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	21
Start date	1 February 2006
Primary completion	1 January 2014
Estimated completion	1 September 2014
Sites	1 location across United States

Drugs / interventions tested

• Estradiol , estriol , progesterone — full drug profile →
• estradiol, progesterone
• estriol, progesterone — full drug profile →
• equine estrogens m-progesteroneacetate — full drug profile →

Conditions studied

• Menopause — all drugs for Menopause →

Sponsor

Jeanne Drisko, MD, CNS, FACN — full company profile →

Who can join

Adults 40 to 65, female only, with Menopause. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Total Cholesterol
  Time frame: Baseline and month 12
  To determine if bioidentical hormone replacement therapy is associated with change in lipid profiles (surrogate marker for cardiovascular disease) when compared to Prempro and provide safety data to proceed to larger trial. This was determined by evaluating lipid levels at baseline and during the 12-month treatment period. Participants' values were averaged at baseline and again at 12 months; the
• Endometrial Measurement
  Time frame: Baseline and month 12
  Baseline and 12 month follow up endovaginal ultrasound(completed at study site only) to evaluate endometrial stripe thickness for change on hormone therapy for all 4 arms. Endometrial thickness was measured in millimeters at baseline and again at 12 month completion. The average of the baseline value was subtracted from the average at completion for each group and reported in mm. Single participan
• Number of Participants Without Change in Baseline and Follow up Mammograms
  Time frame: baseline and month 12
  Comparison at baseline and month 12 by descriptive analysis of breast mammograms. Assessing for changes in density and/or lesions for risk of breast stimulation from hormone replacement therapy. Mammogram readings for participants completing study in descriptive terms. Looking for significant change in breast tissue while on hormone therapy for 12 months. Those who had no change are counted below.

Sponsor's own description

Prospective double blind pilot study comparing bioidentical 'natural' hormones to low-dose PremPro. Forty participants will be enrolled. The purpose of this study is to try to gather early information about safety when "natural" or bioidentical hormones are used during early menopause.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.