Clinical trial · Interventional
Effect of a Natural Health Product on Urinary Estrogen Metabolites
A Clinical Trial to Assess the Efficacy of a Supplemental Formula Targeting Breast Health in Beneficially Altering Urinary Estrogen Metabolites Levels in Both Pre- and Post-menopausal Women
NCT01089049CI-TRIAL-00006597completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if a supplemental formula can beneficially alter the ratio of urinary estrogen metabolites.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FemMED Breast Health Formula | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pre-Menopausal
- interventionNames
- Dietary Supplement: FemMED Breast Health Formula
- type
- EXPERIMENTAL
- label
- Post-Menopausal
- interventionNames
- Dietary Supplement: FemMED Breast Health Formula
Primary outcomes (1)
- measure
- 2-OH Hydroxy Estrone: 16-alpha-OH Estrone
- timeFrame
- Day 0, Day 28
- description
- 2-OHE:16α-OHE1 (2:16 ratio) - 2:16 ratios less than 2.0 indicate increasing long-term risk for breast, cervical, and other estrogen sensitive cancers. Urine samples will be analyzed for the following estrogen metabolites: 2-OH-estrone and 16-α OH-estrone.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Healthy * Willing to collect urine samples and to have blood drawn * Post-menopausal and have not taken hormone replacement therapy (HRT) in the past year (48 subjects) * Pre-menopausal (48 subjects) Exclusion Criteria: * Diagnosed with any major illness(e.g. cancer) * Diabetes, thyroid disease, atypical hyperplasia, fibrocystic breast disease, family history of ovarian cancer, a history of "migraines with aura" * Women taking blood thinner or thyroid medication (including warfarin) * Known allergy to any of the any of the study ingredients * Pregnancy or lactation * Regular consumption in the previous 3 months of any other natural health products (NHPs) or pharmaceutical containing ingredients with a similar effect on estrogen metabolism as those included in the femMED Breast Health treatment * Family history of breast cancer risk * Post-menopausal women on HRT * Pre-menopausal women taking hormonal contraceptives (oral contraceptives, the patch etc.) * All other forms of estrogen, progesterone and/or androgens (i.e. testosterone therapy)
References
Publications (1)
- DERIVEDLaidlaw M, Cockerline CA, Sepkovic DW. Effects of a breast-health herbal formula supplement on estrogen metabolism in pre- and post-menopausal women not taking hormonal contraceptives or supplements: a randomized controlled trial. Breast Cancer (Auckl). 2010 Dec 16;4:85-95. doi: 10.4137/BCBCR.S6505. PMID 21234288