Bioidentical 'Natural' Hormone Evaluation in Early Menopause

This study is currently recruiting participants.

Verified September 2011 by University of Kansas

First Received on March 10, 2006. Last Updated on September 27, 2011 History of Changes

Sponsor:	Jeanne Drisko, MD, CNS, FACN
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

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

Drug Information available for: Estradiol Progesterone Medroxyprogesterone acetate Estradiol cypionate Estradiol valerate Estradiol acetate Estrogens, conjugated

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:	May 2013
Estimated Primary Completion Date:	May 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:	September 27, 2011
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 Acetate
Medroxyprogesterone
Hormones, Hormone Substitutes, and Hormone Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins

ClinicalTrials.gov processed this record on May 21, 2012