An interventional study of Effera® (human equivalent lactoferrin) and Placebo in Womens Health and Menstrual Symptoms, sponsored by Helaina Inc.. Recruiting at 2 sites in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Helaina Inc. · Not applicable, Interventional, and Other
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
Explanation of Study Design This study will be completed as a randomized, double-blind, placebo-controlled investigation with all eligible participants being randomized in an equal allocation (1:1:1:1) to each of the four study groups. Upon screening and providing consent, each study participant will complete baseline assessments and be randomized into one of four groups. Each participant will take their assigned supplement each day for 12 weeks. Approximately every four weeks participants will complete a series of questionnaires intended to evaluate menstrual symptoms, quality of life, gastrointestinal symptoms, health, and more specific menstrual symptoms specifically aligned around their menstrual cycle. Participants are allowed to stop their participation or withdraw at any time.
Supplementation Groups Placebo Effera300 (1 daily dose of 300 mg) Effera100 (1 daily dose of 100 mg) Effera2x100 (2 daily doses of 200 mg)
Participants will be randomized to one of the four arms of the study using simple randomization (ABAB) and an even allocation ratio (1:1:1:1).
Order of Study Procedures (See Study Table Below)
Week 0 (Day -28 to Day -3):
Informed consent process Eligibility determination via review of inclusion/exclusion criteria and medical/health history review Review medications Completion of online survey questionnaires (Menstrual symptoms questionnaire (MSQ-24), PROMIS Global Health 10 (PH-10), Patient Health Questionnaire (PHQ-4), PROMIS-GI Short Form) Complete menstrual complications symptoms questionnaire during first seven days of their next cycle Optional (If available): Sync their compatible wearable device to upload sleep and physical activity data Take first dose Report any adverse events
Weeks 1-3 Complete Patient Health Questionnaire (PHQ-4) each week Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events
Week 4 Complete menstrual complications symptoms questionnaire during first 7 days of menstrual cycle Completion of online survey questionnaires (Menstrual symptoms questionnaire (MSQ-24), PROMIS Global Health 10 (PH-10), Patient Health Questionnaire (PHQ-4), PROMIS-GI Short Form) Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events
Weeks 5-7 Complete Patient Health Questionnaire (PHQ-4) each week Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events
Week 8 Complete menstrual complications symptoms questionnaire during first 7 days of menstrual cycle Completion of online survey questionnaires (Menstrual symptoms questionnaire (MSQ-24), PROMIS Global Health 10 (PH-10), Patient Health Questionnaire (PHQ-4), PROMIS-GI Short Form) Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events
Weeks 9-11 Complete Patient Health Questionnaire (PHQ-4) each week Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data Continue taking assigned supplement Report any adverse events
Week 12 Complete menstrual complications symptoms questionnaire during first 7 days of menstrual cycle Completion of online survey questionnaires (Menstrual symptoms questionnaire (MSQ-24), PROMIS Global Health 10 (PH-10), Patient Health Questionnaire (PHQ-4), PROMIS-GI Short Form) Optional (If available): Continue wearing their wearable device to capture sleep and physical activity data through completion of final assessments Continue taking assigned supplement through completion of final assessments
Study Table Action (Weeks) Information (0) Demographics (0) Inclusion/Exclusion Review (0) Medical/health history review (0) Medication Review (0) Menstrual Symptoms Questionnaire-24 (MSQ-24) (0, 4, 8, 12) PROMIS Global Health (0, 4, 8, 12) Patient Health (PHQ-4) (0, 1, 2, 3, 4, 5, 6, 6, 7, 8, 9, 10, 11, 12) PROMIS-GI Combined Short Form (0, 4, 8, 12) Menstrual Cycle Comfort Questionnaire (Days before mensense, 0, 4, 8, 12) Optional: Sleep \& Physical Activity Tracker (0, 1, 2, 3, 4, 5, 6, 6, 7, 8, 9, 10, 11, 12) Supplement Compliance (0, 1, 2, 3, 4, 5, 6, 6, 7, 8, 9, 10, 11, 12) Adverse Event Reporting (0, 1, 2, 3, 4, 5, 6, 6, 7, 8, 9, 10, 11, 12)
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's planned enrollment of 160 is above the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Helaina Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria to be eligible for participation:
Exclusion Criteria:
Participants will be excluded if any of the following apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a matched placebo supplement daily for 12 weeks.
Other: Placebo
Participants receive 100 mg of effera® (human equivalent lactoferrin) once daily for 12 weeks.
Dietary Supplement: Effera® (human equivalent lactoferrin)
Participants receive 200 mg of effera® daily, administered as two 100 mg doses, for 12 weeks
Dietary Supplement: Effera® (human equivalent lactoferrin)
Participants receive 300 mg of effera® once daily for 12 weeks.
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.
Matched placebo supplement identical in appearance and packaging to the active intervention, administered orally once daily for 12 weeks.
Change in menstrual symptoms (MSQ-24 score)
Menstrual symptoms will be assessed using the validated 24-item Menstrual Symptoms Questionnaire (MSQ-24), which measures the severity and frequency of physical, emotional, and behavioral symptoms associated with the menstrual cycle. Each item will be presented as a 5-level Likert scale (1=Never; 2=Rarely; 3=Sometimes; 4=Often; 5=Always). Higher scores indicate greater symptom burden.
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in global health (PROMIS Global Health-10)
Assesses overall physical and mental health, including quality of life, fatigue, pain, and emotional well-being. This assessment has ten separate items. Nine items are scored on a 5-point scale ranging from 1 to 5 while the remaining item is scored on a scale that ranges from 0 (No Pain to 10 (Worst imaginable pain). The ten items are broken up into a physical health scale and a mental health scale. Each question can be converted to a T-score whereby higher scores indicate better physical or mental health, while pain and fatigue are reverse scored (lower score is better).
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in psychological distress (PHQ-4)
A brief, validated 4-item questionnaire measuring symptoms of anxiety and depression. It consists of four items and provides a general indicator of psychological distress over the previous two weeks. Each item is scored on a 4-item scale (0=Not at all; 1=Several days; 2=More than half the days; 3=Nearly every day) resulting in a possible total score of 0-12 with higher scores indicating more severe feelings of anxiety or depression.
Time frame: Weekly from Baseline through Week 12
Change in gastrointestinal symptoms (PROMIS-GI Short Form)
Assesses frequency and severity of gastrointestinal symptoms such as bloating, abdominal pain, and nausea. This questionnaire has 15 items that are scored between 1 (No discomfort at all) to 7 (Very severe discomfort). Scores are summed across the questionnaire with possible scores ranging from 15 - 105. A higher score indicates more discomfort.
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in menstrual cycle-specific symptoms
Assessed using a menstrual cycle-specific symptom questionnaire completed during the first few days of the most menstrual cycle to evaluate acute symptom changes. The assessment consists of 12 items that are scored on a 3-item scale (0=Not at all; 1=Mild; 2=Moderate; 3=Severe) resulting in total scores that range from 0 to 36.
Time frame: Baseline and monthly during the study (Weeks 4, 8, and 12)
Sleep and physical activity metrics (wearable devices)
Optional wearable-derived measures including time spent in bed (In seconds) and time asleep (In seconds), and physical activity (e.g., daily step count).
Time frame: Continuously collected throughout the 12-week study period
Plan to share: Undecided — De-identified individual participant data may be considered for sharing upon reasonable request, subject to sponsor approval and applicable regulatory, ethical, and privacy requirements. Aggregated results may be used for publication or research purposes.
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