Bioidentical 'Natural' Hormone Evaluation in Early Menopause - Full Text View

Sponsors and Collaborators:	University of Kansas Private Foundation through KU Endowment
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00302731

Purpose

Double blind placebo controlled 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 Drug: estradiol, estriol, progesterone Drug: estriol, progesterone Drug: estradiol, progesterone	Phase II

MedlinePlus related topics: Menopause

Drug Information available for: Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Estriol 16-Epiestriol Progesterone Medroxyprogesterone Medroxyprogesterone 17-acetate Estrogens, conjugated Prempro

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double Blind Placebo Controlled Evaluation of Bioidentical Hormones

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:

Surrogate markers for cardiovascular disease (lipid levels and ECG) [ Time Frame: baseline, 6 months, and at 12-month completion ] [ Designated as safety issue: Yes ]
Secondary: short-term risk profiles for uterine (ultrasound) and breast health (mammogram) and evaluation of bone mass (bone scan) [ Time Frame: baseline and at 12 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	February 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Prempro	Drug: Prempro premarin .45 mg, provera 1.5 mg
2: Experimental Estradiol, estriol, progesterone	Drug: estradiol, estriol, progesterone estradiol 0.5 mg, estriol 2.0 mg, progesterone 100 mg
3: Experimental estriol, progesterone	Drug: estriol, progesterone estriol 2.5 mg, progesterone 100 mg
4: Experimental estradiol,progesterone	Drug: estradiol, progesterone estradiol 0.5 mg, progesterone 100 mg

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: Jeanne A Drisko, MD

913-588-6104

jdrisko@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

University of Kansas

Private Foundation through KU Endowment

Investigators

Principal Investigator:

Jeanne A Drisko, MD

University of Kansas

More Information

Responsible Party:	University of Kansas Medical Center ( Jeanne Drisko )
Study ID Numbers:	9941, GCRC 0024
Study First Received:	March 10, 2006
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00302731
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Estrogens, Conjugated (USP)
Medroxyprogesterone 17-Acetate
Progesterone
Benzoates
Estradiol 3-benzoate
Menopause, Premature

Estradiol valerate
Medroxyprogesterone
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Estradiol
Menopause

Additional relevant MeSH terms:

Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Physiological Effects of Drugs
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female

Reproductive Control Agents
Contraceptive Agents, Male
Hormones
Pharmacologic Actions
Progestins
Therapeutic Uses
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on January 16, 2009