Menopause Clinical Trial
Official title:
A New Hormone Replacement Paradigm: Physiologic Restoration Using Compounded Biomimetic Estradiol, Progesterone and Testosterone Applied Transdermally in a Rhythmic Dose
This is a three-year, prospective, observational study looking at the benefits of rhythmically dosed, bio-identical hormones compounded in a carrier cream in 100 symptomatic peri and postmenopausal women. This study will measure changes in cognition, mood, quality of life, endocrine health, bone mineral density, and reduction of the symptoms of menopause and any adverse effects. The objectives of this study are to show that rhythmic dosing of bio-identical hormones that mimic a menstrual cycle, are possible, and may be more beneficial and have fewer side effects than the current standard of care for treating the symptoms of menopause.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | August 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Symptomatic perimenopausal or menopausal women as determined by symptoms, history, or labs that confirm menopause status. 2. Any women interested in physiologic restoration for HRT replacement. 3. Women with a history of breast, endometrial or ovarian cancer who are seeking HRT regardless of their diagnosis and recommendations not to have HRT. They must understand the risk and give informed dissent. 4. Hysterectomy. Exclusion Criteria: 1. Women who are pregnant and or breastfeeding. 2. Women who may be allergic to the base used for compounding. 3. Previous recent (< 12 months) rhythmic dosing hormone protocol. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Women's Hormone Network |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Symptoms of Menopause | Measure changes in hormone levels and blood chemistry, assess changes in mood and cognitive function, measure changes in brain structure | 36 months | |
Primary | Compliance of this HRT Regimen | Measure compliance of patients on this specific HRT regimen | 36 months | |
Primary | Change in Bone Mineral Density | Bone Mineral Density will be monitored for changes | 36 months | |
Secondary | Incidence of adverse effects | Measure incidence of cancer, embolism, coronary artery disease and stroke | 36 months |
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