Bioidentical 'Natural' Hormone Evaluation in Early Menopause

NCT00302731 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-07-06

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Estradiol , estriol , progesterone

DRUG

estradiol, progesterone

DRUG

estriol, progesterone

DRUG

equine estrogens m-progesteroneacetate

Sponsors & Collaborators

  • Private Foundation through KU Endowment

    collaborator UNKNOWN
  • University of Kansas

    collaborator OTHER
  • Jeanne Drisko, MD, CNS, FACN

    lead OTHER

Principal Investigators

  • Jeanne A Drisko, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2014-01-31
Completion
2014-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00302731 on ClinicalTrials.gov