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Comparison of the Efficacy and Tolerability of Femal Versus Placebo

NCT05762042 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-03-09

No results posted yet for this study

Summary

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

Interventions

OTHER

dietary supplement

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. The mechanism of action of Femal has not yet been fully clarified: Femal inhibits the absorption of serotonin in a dose-dependent manner and has strong antioxidant properties. The lack of estrogenic effects would make this preparation of particular interest for women with a previous hormone-dependent neoplasia who undergo an early iatrogenic menopause. Femal tablets contain a standardized formulation containing: GC Fem pollen extract 40 mg, PI82 pollen / pistil extract 120 mg, vitamin E 5 mg, amino acids 14 mg per tablet. The dosage is 2 tablets a day orally.

Sponsors & Collaborators

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-10
Primary Completion
2022-04-01
Completion
2022-04-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05762042 on ClinicalTrials.gov