Bioidentical 'Natural' Hormone Evaluation in Early Menopause
Condition: Menopause
Intervention: Estradiol , estriol , progesterone; estradiol, progesterone; estriol, progesterone; equine estrogens m-progesteroneacetate
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Hormones; Estradiol; Polyestradiol phosphate; Progesterone; Estrogens
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 21.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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