Bioidentical 'Natural' Hormone Evaluation in Early Menopause

NCT00302731 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 9941
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Outcome Measures

Primary Outcomes (3)

• Change in Total Cholesterol

  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.

  Baseline and month 12

• Endometrial Measurement

  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.

  Baseline and month 12

• Number of Participants Without Change in Baseline and Follow up Mammograms

  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.

  baseline and month 12

Secondary Outcomes (1)

• Number of Participants Without Change in Baseline and Follow up Bone Density

  baseline and 12 months

Study Arms (4)

1 equine estrogens m-progesteroneacetate

ACTIVE COMPARATOR

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

2 estradiol estriol progesterone

EXPERIMENTAL

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

4 estradiol progesterone

EXPERIMENTAL

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

3 estriol progesterone

EXPERIMENTAL

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

Interventions

Estradiol , estriol , progesterone DRUG

Also known as: compounded bioidentical hormone

2 estradiol estriol progesterone

estradiol, progesterone DRUG

Also known as: compunded bioidentical hormone

4 estradiol progesterone

estriol, progesterone DRUG

Also known as: compounded bioidentical hormone

3 estriol progesterone

equine estrogens m-progesteroneacetate DRUG

Also known as: Premarin and Provera, Prempro

1 equine estrogens m-progesteroneacetate

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Jeanne Drisko, MD, CNS, FACN: lead
• Private Foundation through KU Endowment: collaborator
• University of Kansas: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Interventions

Estradiol; Estriol; Progesterone; Estrogens, Conjugated (USP); Medroxyprogesterone Acetate; Prempro

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners; Medroxyprogesterone; Hydroxyprogesterones

Results Point of Contact

• Title: Jeanne A Drisko, MD, CNS, FACN
• Organization: University of Kansas Medical Center

jdrisko@kumc.edu

913-588-6208

Study Officials

• Jeanne A Drisko, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Integrative Medicine

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 14, 2006
• Study Start: February 1, 2006
• Primary Completion: January 1, 2014
• Study Completion: September 1, 2014
• Last Updated: July 6, 2018
• Results First Posted: May 16, 2018

Record last verified: 2018-06

Locations

US (1)