RecruitingNot ApplicableNCT07524270

Effera Dose Response: Women's Health

Dose-Response of Effera® Supplementation for Women's Health Outcomes


Sponsor

Helaina Inc.

Enrollment

160 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if a human equivalent lactoferrin supplement (effera®) can improve menstrual symptoms, mood, and quality of life in healthy women aged 18-40. The main questions it aims to answer are: Does effera® reduce the severity of menstrual symptoms? Does effera® improve mood, gastrointestinal symptoms, and overall well-being? Researchers will compare three different doses of effera® to a placebo (a look-alike supplement with no active ingredient) to see if the supplement improves these outcomes. Participants will: Take the assigned supplement (effera® or placebo) daily for 12 weeks Complete online questionnaires about menstrual symptoms, mood, and health Optionally share sleep and activity data from a wearable device


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Effera® (human equivalent lactoferrin) and Placebo for people with menstrual symptoms and womens health. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTEffera® (human equivalent lactoferrin)

Effera® is a human equivalent lactoferrin supplement administered orally once daily at varying doses (100 mg, 200 mg, or 300 mg) depending on randomized assignment. Lactoferrin is a naturally occurring protein involved in immune regulation, iron metabolism, and inflammation.

OTHERPlacebo

Matched placebo supplement identical in appearance and packaging to the active intervention, administered orally once daily for 12 weeks.


Locations(2)

Alethios

San Francisco, California, United States

Alethios, Inc.

San Francisco, California, United States

View Full Details on ClinicalTrials.gov

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NCT07524270


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