Bioidentical 'Natural' Hormone Evaluation in Early Menopause

Sponsor
Jeanne Drisko, MD, CNS, FACN (Other)
Overall Status
Terminated
CT.gov ID
NCT00302731
Collaborator
Private Foundation through KU Endowment (Other), University of Kansas (Other)
21
1
4
103
0.2

Study Details

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
  • Drug: Estradiol , estriol , progesterone
  • Drug: estradiol, progesterone
  • Drug: estriol, progesterone
  • Drug: equine estrogens m-progesteroneacetate
Phase 2

Detailed Description

In spite of warnings regarding safety and adverse events widely publicized after the Women's Health Initiative (WHI), women continue to seek hormone replacement therapy for a variety of reasons. Increased cardiovascular events identified in WHI are an important concern for considering menopausal hormone replacement. There is the belief the 'natural' or bioidentical hormone replacement therapy could provide a safe alternative to widely used synthetic hormone replacement therapy. However, this has never been studied with any rigor and health care providers can not adequately advise patients seeking 'natural' bioidentical hormone therapy.

This feasibility pilot study is designed as a prospective double blind study comparing 4 groups of women who are within 7 years of menopause. There will be 10 women in each of the 4 groups with a total of 40 women enrolled and these women will be treated for 12 months.

The Long-Term Goal is to provide health care practitioners and consumers with evidence-based recommendations for the use of bioidentical hormone replacement. The Short-Term Goal of this pilot study is to determine if it is feasible to conduct a study in bioidentical hormones and obtain information that could lead to a larger more definitive study. We would like to provide safety information for bioidentical hormone use by evaluating surrogate markers for cardiovascular disease (lipid levels), with secondary evaluation of breast (mammogram) and uterus (endovaginal ultrasound), and to collect information about bone preservation.

The information gained from this trial will provide information for a future trial to test the hypothesis that bioidentical hormone replacement therapy provides a safe alternative to standard hormone replacement therapy: To determine if bioidentical hormone replacement therapy is associated with improved lipid profiles (surrogate marker for cardiovascular disease) when compared to Prempro. This will be determined by evaluating lipid levels at baseline and during the 12-month treatment period.

Secondary hypotheses will also be evaluated in the future to include:
  1. To determine if bioidentical hormone replacement therapy provides improved short-term risk profiles for uterine and breast health when compared to Prempro. This will be accomplished by requiring mammograms and endovaginal ultrasounds at baseline and the end of the 12-month treatment period.

  2. To determine if there is bone loss when using bioidentical hormone replacement when compared to Prempro. This aim will be evaluated by Dexa bone scan at baseline and at 12 months.

Subjects will randomly be assigned to one of the four arms of the study for the 12 months of treatment. The standard of care arm will consist of 10 women receiving in a double blind fashion low-dose Prempro. There will be 3 treatment arms consisting of different combinations of E2 estradiol and/or E3 estriol, all combined with bioidentical progesterone. These 3 arms will each have 10 subjects randomized and the bioidentical hormone delivered in a double blind fashion. Since the gold standard for treatment is the conventional arm (Prempro), we will compare each bioidentical arms to the gold standard. This comparison will occur at the end of 12 months of treatment. In this pilot study, we also wish to collect preliminary data about the comparisons between the 3 bioidentical hormone arm and the conventional arm. This is necessary because there is currently anecdotal evidence that E3 alone without combination with E2 may constitute adequate therapy in spite of its low biological activity at the estrogen receptor. The use of high doses of E3 with or without E2 is in common use by complementary and alternative practitioners.

It is expected in this small pilot study that bioidentical hormone will provide an adequate short-term safety profile for cardiovascular, breast and uterine health that will provide guidance for a larger trial that is longer in duration. It is also expected that bone density may be maintained by bioidentical hormone replacement when compared to Prempro. There may not be sufficient numbers to determine significance between the control arm and the treatment arms; however, we expect to collect useful information for future trials. It is assumed that equivalence will not likely be determined based on the sample size.

Study Design

Study Type:
Interventional
Actual Enrollment :
21 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 :
Feb 1, 2006
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1 equine estrogens m-progesteroneacetate

Menopausal women in first seven years of menopause randomized to arm 1 receive conjugated equine estrogens 0.45 mg combined with medroxyprogesteroneacetate 1.5 mg placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.

Drug: equine estrogens m-progesteroneacetate
Other Names:
  • Premarin and Provera
  • Prempro
  • Experimental: 2 estradiol estriol progesterone

    Menopausal women in first seven years of menopause randomized to arm 2 estradiol .5mg, estriol 2.0mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.

    Drug: Estradiol , estriol , progesterone
    Other Names:
  • compounded bioidentical hormone
  • Experimental: 4 estradiol progesterone

    Menopausal women in first seven years of menopause randomized to arm 4 estradiol 0.5 mg, progesterone 100 mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.

    Drug: estradiol, progesterone
    Other Names:
  • compunded bioidentical hormone
  • Experimental: 3 estriol progesterone

    Menopausal women in first seven years of menopause randomized to arm 3 estriol 2.5mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.

    Drug: estriol, progesterone
    Other Names:
  • compounded bioidentical hormone
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Total Cholesterol [Baseline and month 12]

      To determine if bioidentical hormone replacement therapy is associated with change in lipid profiles (surrogate marker for cardiovascular disease) when compared to Prempro and provide safety data to proceed to larger trial. This was determined by evaluating lipid levels at baseline and during the 12-month treatment period. Participants' values were averaged at baseline and again at 12 months; the average of the baseline value was subtracted from the average at completion.

    2. Endometrial Measurement [Baseline and month 12]

      Baseline and 12 month follow up endovaginal ultrasound(completed at study site only) to evaluate endometrial stripe thickness for change on hormone therapy for all 4 arms. Endometrial thickness was measured in millimeters at baseline and again at 12 month completion. The average of the baseline value was subtracted from the average at completion for each group and reported in mm. Single participant in Arm 2: compared baseline to completion.

    3. Number of Participants Without Change in Baseline and Follow up Mammograms [baseline and month 12]

      Comparison at baseline and month 12 by descriptive analysis of breast mammograms. Assessing for changes in density and/or lesions for risk of breast stimulation from hormone replacement therapy. Mammogram readings for participants completing study in descriptive terms. Looking for significant change in breast tissue while on hormone therapy for 12 months. Those who had no change are counted below.

    Secondary Outcome Measures

    1. Number of Participants Without Change in Baseline and Follow up Bone Density [baseline and 12 months]

      Comparison at baseline and month 12 by descriptive analysis of bone density. Assessing for changes in density related to hormone replacement therapy. Bone density readings for participants completing study in descriptive terms. Looking for significant change in bone density while on hormone therapy for 12 months. Those who had no change are counted below.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    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

    Locations

    Site City State Country Postal Code
    1 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

    Investigators

    • Principal Investigator: Jeanne A Drisko, MD, University of Kansas Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeanne Drisko, MD, CNS, FACN, Director Integrative Medicine, University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT00302731
    Other Study ID Numbers:
    • 9941
    First Posted:
    Mar 14, 2006
    Last Update Posted:
    Jul 6, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Double blind single site pilot clinical trial conducted at academic medical center. Participants randomized to one of 4 arms by computer assignment conducted at independent site not enrolling subjects.
    Pre-assignment Detail If participants were on hormone replacement at enrollment, needed to have 3 month washout period before randomization. Participants were required to be nonsmokers, have intact uterus, and be menopausal. Screening ultrasound of the uterus, bone density, screening metabolic panel, and baseline mammogram were required.
    Arm/Group Title Participants Randomized to Arm 1 Participants Randomized to Arm 2 Participants Randomized to Arm 3 Participants Randomized to Arm 4
    Arm/Group Description Participants in Arm 1 received Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate Prempro, premarin, provera conjugated estrogens, medroxyprogesterone acetate: Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate Participants in Arm 2 received compounded Estradiol .5mg, estriol 210mg, progesterone 100mg Estradiol , estriol , progesterone: Estradiol .5mg, estriol 210mg, progesterone 100mg Participants in Arm 3 received compounded estriol 2.5mg, progesterone 100mg estriol, progesterone: estriol 2.5mg, progesterone 100mg estradiol,progesterone estradiol,progesterone: estradiol,progesterone
    Period Title: Overall Study
    STARTED 6 6 5 4
    COMPLETED 2 1 2 4
    NOT COMPLETED 4 5 3 0

    Baseline Characteristics

    Arm/Group Title Study Arm 1 Study Arm 2 Study Arm 3 Study Arm 4 Total
    Arm/Group Description Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate Prempro, premarin, provera conjugated estrogens, medroxyprogesterone acetate: Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate Estradiol .5mg, estriol 210mg, progesterone 100mg Estradiol , estriol , progesterone: Estradiol .5mg, estriol 210mg, progesterone 100mg estriol 2.5mg, progesterone 100mg estriol, progesterone: estriol 2.5mg, progesterone 100mg estradiol,progesterone estradiol,progesterone: estradiol,progesterone Total of all reporting groups
    Overall Participants 6 6 5 4 21
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    6
    100%
    6
    100%
    5
    100%
    4
    100%
    21
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Sex: Female, Male (Count of Participants)
    Female
    6
    100%
    6
    100%
    5
    100%
    4
    100%
    21
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    6
    100%
    6
    100%
    5
    100%
    4
    100%
    21
    100%

    Outcome Measures

    1. Primary Outcome
    Title Change in Total Cholesterol
    Description To determine if bioidentical hormone replacement therapy is associated with change in lipid profiles (surrogate marker for cardiovascular disease) when compared to Prempro and provide safety data to proceed to larger trial. This was determined by evaluating lipid levels at baseline and during the 12-month treatment period. Participants' values were averaged at baseline and again at 12 months; the average of the baseline value was subtracted from the average at completion.
    Time Frame Baseline and month 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Study Arm 1 Study Arm 2 Study Arm 3 Study Arm 4
    Arm/Group Description Menopausal women in first seven years of menopause randomized to arm 1 receive conjugated equine estrogens 0.45 mg combined with medroxyprogesteroneacetate 1.5 mg placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Menopausal women in first seven years of menopause randomized to arm 2 estradiol .5mg, estriol 2.0mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Menopausal women in first seven years of menopause randomized to arm 3 estriol 2.5mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Menopausal women in first seven years of menopause randomized to arm 4 estradiol 0.5 mg, progesterone 100 mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
    Measure Participants 2 1 2 4
    Mean (Standard Deviation) [mg/dL]
    221.5
    (12.5)
    221.5
    (0)
    223
    (26)
    165.5
    (11)
    2. Primary Outcome
    Title Endometrial Measurement
    Description Baseline and 12 month follow up endovaginal ultrasound(completed at study site only) to evaluate endometrial stripe thickness for change on hormone therapy for all 4 arms. Endometrial thickness was measured in millimeters at baseline and again at 12 month completion. The average of the baseline value was subtracted from the average at completion for each group and reported in mm. Single participant in Arm 2: compared baseline to completion.
    Time Frame Baseline and month 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Study Arm 1 Study Arm 2 Study Arm 3 Study Arm 4
    Arm/Group Description Menopausal women in first seven years of menopause randomized to arm 1 receive conjugated equine estrogens 0.45 mg combined with medroxyprogesteroneacetate 1.5 mg placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Menopausal women in first seven years of menopause randomized to arm 2 estradiol .5mg, estriol 2.0mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Menopausal women in first seven years of menopause randomized to arm 3 estriol 2.5mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Menopausal women in first seven years of menopause randomized to arm 4 estradiol 0.5 mg, progesterone 100 mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
    Measure Participants 2 1 2 4
    Mean (Standard Deviation) [mm]
    13.0
    (0)
    10.0
    (0)
    2.5
    (0.7)
    3.1
    (0.7)
    3. Primary Outcome
    Title Number of Participants Without Change in Baseline and Follow up Mammograms
    Description Comparison at baseline and month 12 by descriptive analysis of breast mammograms. Assessing for changes in density and/or lesions for risk of breast stimulation from hormone replacement therapy. Mammogram readings for participants completing study in descriptive terms. Looking for significant change in breast tissue while on hormone therapy for 12 months. Those who had no change are counted below.
    Time Frame baseline and month 12

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Study Arm 1 Study Arm 2 Study Arm 3 Study Arm 4
    Arm/Group Description Menopausal women in first seven years of menopause randomized to arm 1 receive conjugated equine estrogens 0.45 mg combined with medroxyprogesteroneacetate 1.5 mg placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Menopausal women in first seven years of menopause randomized to arm 2 estradiol .5mg, estriol 2.0mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Menopausal women in first seven years of menopause randomized to arm 3 estriol 2.5mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Menopausal women in first seven years of menopause randomized to arm 4 estradiol 0.5 mg, progesterone 100 mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
    Measure Participants 2 1 2 4
    Count of Participants [Participants]
    2
    33.3%
    1
    16.7%
    2
    40%
    4
    100%
    4. Secondary Outcome
    Title Number of Participants Without Change in Baseline and Follow up Bone Density
    Description Comparison at baseline and month 12 by descriptive analysis of bone density. Assessing for changes in density related to hormone replacement therapy. Bone density readings for participants completing study in descriptive terms. Looking for significant change in bone density while on hormone therapy for 12 months. Those who had no change are counted below.
    Time Frame baseline and 12 months

    Outcome Measure Data

    Analysis Population Description
    Only 7 participants completed both the baseline bone density and 12-month follow up bone density resulting in a discrepancy in evaluable numbers compared to other outcome measures.
    Arm/Group Title Study Arm 1 Study Arm 2 Study Arm 3 Study Arm 4
    Arm/Group Description Menopausal women in first seven years of menopause randomized to arm 1 receive conjugated equine estrogens 0.45 mg combined with medroxyprogesteroneacetate 1.5 mg placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Menopausal women in first seven years of menopause randomized to arm 2 estradiol .5mg, estriol 2.0mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Menopausal women in first seven years of menopause randomized to arm 3 estriol 2.5mg, progesterone 100mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels. Menopausal women in first seven years of menopause randomized to arm 4 estradiol 0.5 mg, progesterone 100 mg dosed orally / day placed in a placebo capsule to disguise contents from participant and study team. Drug dosed daily for 1 year. Screening FSH and PAP. Baseline mammogram, bone density, pelvic ultrasound, EKG, blood work for cholesterol panel (surrogate marker for cardiovascular disease), BUN/Creatinine. Repeated at 12 months. Safety check at 6 months includes BUN/creatinine, EKG, cholesterol panel, estradiol, progesterone levels.
    Measure Participants 1 1 2 3
    Count of Participants [Participants]
    1
    16.7%
    1
    16.7%
    2
    40%
    3
    75%

    Adverse Events

    Time Frame Each participant had monitoring for adverse events from enrollment through the 1 year on trial.
    Adverse Event Reporting Description
    Arm/Group Title Study Arm 1 Study Arm 2 Study Arm 3 Study Arm 4
    Arm/Group Description Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate Prempro, premarin, provera conjugated estrogens, medroxyprogesterone acetate: Prempro, premarin .45mg, provera 1.5mg conjugated estrogens, medroxyprogesterone acetate Estradiol .5mg, estriol 210mg, progesterone 100mg Estradiol , estriol , progesterone: Estradiol .5mg, estriol 210mg, progesterone 100mg estriol 2.5mg, progesterone 100mg estriol, progesterone: estriol 2.5mg, progesterone 100mg estradiol,progesterone estradiol,progesterone: estradiol,progesterone
    All Cause Mortality
    Study Arm 1 Study Arm 2 Study Arm 3 Study Arm 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 0/6 (0%) 0/5 (0%) 0/4 (0%)
    Serious Adverse Events
    Study Arm 1 Study Arm 2 Study Arm 3 Study Arm 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 0/6 (0%) 0/5 (0%) 0/4 (0%)
    Other (Not Including Serious) Adverse Events
    Study Arm 1 Study Arm 2 Study Arm 3 Study Arm 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 2/6 (33.3%) 2/5 (40%) 0/4 (0%)
    Metabolism and nutrition disorders
    Lethargy 0/6 (0%) 0 1/6 (16.7%) 1 0/5 (0%) 0 0/4 (0%) 0
    Reproductive system and breast disorders
    Abnormal vaginal bleeding 0/6 (0%) 0 1/6 (16.7%) 1 2/5 (40%) 2 0/4 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Jeanne A Drisko, MD, CNS, FACN
    Organization University of Kansas Medical Center
    Phone 913-588-6208
    Email jdrisko@kumc.edu
    Responsible Party:
    Jeanne Drisko, MD, CNS, FACN, Director Integrative Medicine, University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT00302731
    Other Study ID Numbers:
    • 9941
    First Posted:
    Mar 14, 2006
    Last Update Posted:
    Jul 6, 2018
    Last Verified:
    Jun 1, 2018