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Bioidentical 'Natural' Hormone Evaluation in Early Menopause

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00302731
Recruitment Status : Completed
First Posted : March 14, 2006
Last Update Posted : January 7, 2014
Information provided by (Responsible Party):

Study Description
Brief 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.

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

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Double Blind Evaluation of Bioidentical Hormones
Study Start Date : February 2006
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones Menopause
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Drug: estradiol,progesterone
Active Comparator: 3
estriol 2.5mg, progesterone 100mg
Drug: estriol, progesterone
estriol 2.5mg, progesterone 100mg

Outcome Measures

Primary Outcome Measures :
  1. evaluating surrogate markers for cardiovascular disease (lipid levels) [ Time Frame: baseline, 6 months, and at 12-month completion ]

Secondary Outcome Measures :
  1. Secondary evaluation of breast (mammogram)and uterus (endovaginal ultrasound) and to collect information about bone preservation [ Time Frame: baseline, and at 12-month completion ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302731

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Jeanne Drisko, MD, CNS, FACN
Private Foundation through KU Endowment
University of Kansas
Principal Investigator: Jeanne A Drisko, MD University of Kansas Medical Center
More Information

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
First Posted: March 14, 2006    Key Record Dates
Last Update Posted: January 7, 2014
Last Verified: January 2014

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