Clinical trial · Interventional
Comparison of the Efficacy and Tolerability of Femal Versus Placebo
Comparison of the Efficacy and Tolerability of Femal Versus Placebo in the Treatment of Hot Flashes in Patients With Previous Breast Cancer
- 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)
Femal, a food supplement based on pollen extracts introduced in Europe in 1999, is a non-estrogenic alternative to hormone replacement therapy in women with vasomotor symptoms. Patients with prior breast cancer, spontaneous or iatrogenic menopause or who are premenopausal with ovarian function suppressed by GNRH analogue and experiencing severe vasomotor symptoms (at least 20 hot flashes per week) will be included. Patients who are on tamoxifen or anti-estrogen or aromatase inhibitor therapy are eligible if started at least 2 months prior to study entry. Patients on SSRI or SNRI antidepressant therapy are excluded. Eligible patients will be randomly assigned to either Femal (2 cp/day) or placebo (2 cp/day) for 3 months (double-blind study).
Conditions
Conditions (2)
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 |
| Menopause | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dietary supplement | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Femal
- description
- Patients in this arm will receive FEMAL (2 cp/die) for three months long
- interventionNames
- Other: dietary supplement
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients in this arm will receive PLACEBO (2 cp/die) for three months long
- interventionNames
- Other: dietary supplement
Primary outcomes (1)
- measure
- efficacy of Femal in reducing the mean score of vasomotor symptoms between baseline (T0) and month 3 (T2).
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: \- patients with a history of breast cancer, in spontaneous or iatrogenic menopause or who are premenopausal with ovarian function suppressed by GNRH analogue and experiencing severe vasomotor symptoms (at least 20 hot flushes per week). Patients who are on tamoxifen or aromatase anti-estrogen or aromatase inhibitor therapy are eligible if started at least 2 months prior to study entry Exclusion Criteria: * Patients on SSRI or SNRI antidepressant therapy are excluded
References
Publications (0)
Data not yet available