Status:
COMPLETED
A Pharmacokinetic Evaluation of Bioidentical Compounded Estrogen Cream and Natural Progesterone
Lead Sponsor:
Mayo Clinic
Conditions:
Menopause
Eligibility:
FEMALE
40-60 years
Phase:
PHASE1
Brief Summary
Bioidentical compounded hormone therapy (BCHT) is considered a 'safer' option to the conventional hormones (HT) by its proponents. However, there is limited research data to support their claims. Our ...
Detailed Description
This study is designed as a Phase I, blinded, randomized, four-arm clinical trial. Participants will be randomized to one of the four interventions: Biest transdermal cream 2.0 mg/0.5 g daily, Biest 2...
Eligibility Criteria
Inclusion
- Women 40-60 years old;
- Postmenopausal status, as documented by absence of periods for ≥ 1 year or amenorrhea for ≥ 6 months along with FSH ≥ 40 IU/L;
- Surgical menopause;
- History of a normal mammogram within the last 11 months;
- Normal screening labs (within 20% of upper limit of lab normal);
- Able to understand and sign informed consent; and
- Able and willing to be in a monitored CRU setting and provide blood samples as requested.
Exclusion
- Contraindications to the use of hormones because of personal history of coronary artery disease, stroke, breast cancer, DVT/PE, active liver or gall bladder disease, hormone dependent migraine headaches, endometrial, ovarian or other hormone dependent cancers;
- Medical conditions increasing the risk of complications from hormone replacement such as uncontrolled hypertension (\>160/100 mmHg), smoking, diabetes and lupus;
- Current use of estrogen, progesterone or testosterone;Depending on the drug, it could be 7 days to 6 months.
- Current use of isoflavone containing products;
- Current use of protein binding medications like rifampin, warfarin, antiepileptic drugs (effect on estrogen bioavailability);
- Family history of premenopausal breast cancer in a first degree relative, two or more premenopausal breast cancers in second degree relatives, male breast cancer, ovarian cancer in two or more relatives and; and
- Women with alcohol or substance abuse or dementia (compliance issues).
- Women who are more than ten years from their last menstrual period (unfavorable risk : benefit ratio)
- Women with peanut allergy (Prometrium has peanut oil)
- Women who are found to have premenopausal estrogen levels, as confirmed by a baseline Estradiol level of \>35 pg/ml and vaginal ultrasound suggesting ovarian activity.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00864214
Start Date
June 1 2008
End Date
April 1 2010
Last Update
January 16 2012
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905