Clinical trial · Interventional
Effect of 4-Hydroxytamoxifen Gel on Breast Density, Salivary Sex Steroids, and Quality of Life in Premenopausal Women
A Prospective, Randomized, Placebo-Controlled Trial of the Effects of 4-Hydroxytamoxifen Gel on Breast Density, Salivary Sex Steroids, and Quality of Life in Premenopausal Women
- 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)
RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. 4-hydroxytamoxifen gel (a substance made when tamoxifen breaks down in the body) may be effective in reducing breast density by reducing estrogen levels with fewer side effects than tamoxifen. This may improve quality of life and the ability to detect breast cancer with screening mammography. PURPOSE: Randomized screening study to determine the effect of 4-hydroxytamoxifen gel on breast density, salivary sex steroids (hormones), and quality of life in premenopausal women.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4-hydroxytamoxifen | Drug | Afimoxifene | ALIAS |
| breast imaging study | Procedure | — | UNRESOLVED |
| radiomammography | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Premenopausal as determined by a menstrual history of no change in menstrual pattern within the past 6 months * Undergoing mammography at least annually * No prior breast cancer * No clinical breast abnormalities suspicious for cancer * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 30 to 50 Sex * Female Menopausal status * See Disease Characteristics Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Not pregnant or nursing * Fertile patients must use effective barrier contraception * No medical or psychiatric disorder that would preclude giving informed consent PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * More than 3 months since prior oral contraceptives or other estrogen- or progesterone-containing drugs * No prior tamoxifen for more than 1 month duration * No concurrent oral contraceptives or other estrogen- or progesterone-containing drugs * No other concurrent antiestrogen medications Radiotherapy * Not specified Surgery * Not specified
References
Publications (0)
Data not yet available