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Bioidentical 'Natural' Hormone Evaluation in Early Menopause

This study is currently recruiting participants.
Verified April 2013 by University of Kansas
Sponsor:
Collaborators:
Private Foundation through KU Endowment
University of Kansas
Information provided by (Responsible Party):
Jeanne Drisko, MD, CNS, FACN, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00302731
First received: March 10, 2006
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Menopause
 Drug: Prempro, premarin, provera conjugated estrogens, medroxyprogesterone acetate
Drug: Estradiol , estriol , progesterone
Drug: estradiol,progesterone
Drug: estriol, progesterone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Double Blind Evaluation of Bioidentical Hormones

Resource links provided by NLM:

MedlinePlus related topics: Menopause
U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • evaluating surrogate markers for cardiovascular disease (lipid levels) [ Time Frame: baseline, 6 months, and at 12-month completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary evaluation of breast (mammogram)and uterus (endovaginal ultrasound) and to collect information about bone preservation [ Time Frame: baseline, and at 12-month completion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: February 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate
 Drug: Prempro, premarin, provera conjugated estrogens, medroxyprogesterone acetate
Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate
Experimental: 2
Estradiol .5mg, estriol 210mg, progesterone 100mg
 Drug: Estradiol , estriol , progesterone
Estradiol .5mg, estriol 210mg, progesterone 100mg
Experimental: 4
estradiol,progesterone
 Drug: estradiol,progesterone
estradiol,progesterone
Active Comparator: 3
estriol 2.5mg, progesterone 100mg
 Drug: estriol, progesterone
estriol 2.5mg, progesterone 100mg

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Ambulatory
  • Within 7 years post menopause
  • Positive history of menopausal symptoms such as vasomotor symptoms or osteoporosis in a study subject unable to tolerate bisphosphonates
  • FSH greater than 20 mIU/mL
  • Intact uterus and at least one intact ovary
  • Amenorrhea for 3 months or greater up to 7 years
  • Normal pap smear results within 12 months
  • Normal mammogram result within 12 months
  • Agreeable to a 3 month washout period with no hormones prior to entering the trial
  • Women who have no language barrier, are cooperative, and who can give informed consent before entering this study

Exclusion Criteria:

  • Unwilling to take hormone replacement for the 12 month period
  • Evidence of clinically significant psychiatric disorder by history/examination that would prevent the patient from completing the study.
  • Active deep venous thrombosis, pulmonary embolism, or a history of these conditions
  • Active or recent arterial thromboembolic disease
  • Undiagnosed vaginal bleeding
  • Hypersensitivity to ingredients in Prempro
  • Patients with known current bone disorders other than primary osteoporosis
  • Patients with pathological fractures
  • Patients with suspected or history of carcinoma of the breast or estrogen dependent neoplasms such as endometrial carcinoma.
  • Patients who have ≥ 5mm endometrial thickness by endovaginal (transvaginal) ultrasound.
  • Patients who have impaired renal function evidenced by serum creatinine greater than 2.5 mg/dL.
  • Patients who have impaired hepatic function evidenced by transaminase (AST/ALT) ≥2.5X upper limit
  • Patients with severe malabsorption syndromes.
  • Patients who consume an excess of alcohol or abuse drugs (an excess of alcohol is defined as more than four of any one or combination of the following per day: 30 mL distilled spirits, 340 mL beer, or 120 mL wine).

  • Treatment with therapeutic doses of any of the following medications more recently than 3 months:

    • Estrogen
    • Calcitonin
    • Corticosteroids
    • Progestins
    • Progesterone
    • Lithium
    • Androgen
    • Heparin
    • Herbal menopause treatments
    • SERMS
    • Fluorides
    • Phosphate binding antacids
    • Bisphosphonates
    • Vitamin D 50,000IU
    • Anticonvulsants
  • Patients who received any investigational drug within the proceeding month
  • Tobacco use will not be allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302731

Contacts
Contact: Jean Sunega 913-588-6104 jsunega@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Jeanne A Drisko, MD     913-588-6104     jdrisko@kumc.edu    
Principal Investigator: Jeanne A Drisko, MD            
Sponsors and Collaborators
Jeanne Drisko, MD, CNS, FACN
Private Foundation through KU Endowment
University of Kansas
Investigators
Principal Investigator: Jeanne A Drisko, MD University of Kansas
  More Information

No publications provided

Responsible Party: Jeanne Drisko, MD, CNS, FACN, Director Integrative Medicine, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00302731     History of Changes
Other Study ID Numbers: 9941, GCRC 0024
Study First Received: March 10, 2006
Last Updated: April 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Estrogens, Conjugated (USP)
Estrogens
Hormones
Progesterone
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Medroxyprogesterone
Medroxyprogesterone Acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Progestins

ClinicalTrials.gov processed this record on May 19, 2013