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Led by Helaina Inc. · Updated on 2026-04-13
160
Participants Needed
2
Research Sites
4 weeks
Total Duration
Researchers are evaluating whether a human equivalent lactoferrin supplement called Effera can improve menstrual symptoms, mood, gastrointestinal symptoms, and overall quality of life in healthy women aged 18 to 40. The study compares three different doses of Effera to a placebo to see if the supplement reduces the severity of menstrual symptoms and improves well-being. Participants are randomly assigned to one of four groups a placebo group, or one of three Effera dose groups 100 mg once daily, 200 mg daily given as two 100 mg doses, or 300 mg once daily. They take their assigned supplement daily for 12 weeks. The study is conducted as a triple-blind, randomized, placebo-controlled trial with equal allocation among groups. During the study, participants complete online questionnaires about menstrual symptoms, mood, gastrointestinal health, and quality of life at baseline and every four weeks through week 12. They also complete weekly mood assessments and optional sharing of sleep and activity data from wearable devices. Researchers monitor supplement adherence and adverse events throughout the trial. The primary outcome is change in menstrual symptoms measured at baseline and weeks 4, 8, and 12.
CONDITIONS
Effera Dose Response: Women's Health
C
Chad Kerksick, PhD
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Helaina Inc.
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Effera® 100 mg (Oral Daily) | Placebo (Oral Daily) | Effera® 200 mg (Split Dose, Oral Daily) | Effera® 300 mg (Oral Daily) |
|---|---|---|---|---|
| What it is | Effera® (human equivalent lactoferrin) oral supplement at 100 mg daily for 12 weeks. | Oral placebo supplement identical in appearance to Effera®, without active ingredient, taken daily for 12 weeks. | Effera® (human equivalent lactoferrin) oral supplement at 200 mg total daily (split dose) for 12 weeks. | Effera® (human equivalent lactoferrin) oral supplement at 300 mg daily for 12 weeks. |
| Role in study | Assesses the efficacy and safety of 100 mg Effera® compared with placebo and higher doses. | Serves as the blinded control group for comparison with all active dose groups. | Assesses the efficacy and safety of a total daily dose of 200 mg Effera® (in split doses) compared with placebo and other doses. | Assesses the efficacy and safety of 300 mg Effera® daily compared with placebo and lower doses. |
| Primary use | Studied to evaluate whether a daily dose of 100 mg Effera® can help reduce menstrual symptoms and associated impacts. | Used to assess the effect of Effera® on menstrual symptoms by providing a comparison group without active lactoferrin. | Studied to evaluate whether a split daily dose totaling 200 mg Effera® helps in reducing menstrual symptoms and related effects. | Studied to evaluate whether a 300 mg daily dose of Effera® provides improvement in menstrual symptoms and overall well-being. |
| How it is given or performed | Effera® capsule containing 100 mg human equivalent lactoferrin, taken orally once per day for 12 weeks. | Oral supplement (no active ingredient), taken once daily for 12 weeks. | Effera® capsules containing a total of 200 mg lactoferrin, taken as a split dose daily for 12 weeks. | Effera® capsules containing 300 mg lactoferrin, taken orally once per day for 12 weeks. |
| Current evidence status | The effect of Effera® 100 mg on menstrual symptoms in women is being studied; final results are not yet established. | No active benefit is expected from placebo; it serves as a comparator to quantify the effect of Effera®. | The effect of Effera® 200 mg (split dose) on menstrual symptoms in women is under investigation; results are not yet established. | The effect of Effera® 300 mg on menstrual symptoms in women is under investigation; results are not yet established. |
| Important limitations | The effects of 100 mg Effera® in the studied population are not yet established; no prior published randomized trials using human equivalent lactoferrin in this population were identified. | The placebo does not provide any active supplement and does not represent available management options for menstrual symptoms outside of trial settings. | With no published studies of human equivalent lactoferrin at this dose for menstrual symptoms, evidence for efficacy and safety is limited to this ongoing research. | No published data on Effera® 300 mg in this population is available; ongoing research will help establish tolerability and effect. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 12 weeks
Participants take their assigned supplement daily for 12 weeks. Approximately every four weeks, participants complete a series of questionnaires related to menstrual symptoms, quality of life, gastrointestinal symptoms, and other health aspects. Participants may optionally use a wearable device to track sleep and physical activity throughout the treatment.
Weekly online questionnaires and approximately 4 assessment visits during the study
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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