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RECRUITING
NCT07524270
NA

Effera Dose Response: Women's Health

Sponsor: Helaina Inc.

View on ClinicalTrials.gov

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

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

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-04

Completion Date

2026-12

Last Updated

2026-04-13

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Effera® (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.

OTHER

Placebo

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