Womens HealthNCT07524270
Effera Dose Response: Women's Health
A study testing Effera® (human equivalent lactoferrin) in people with Womens Health and Menstrual Symptoms, run by Helaina Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Womens Health, Menstrual Symptoms
- What is being tested?
- Effera® (human equivalent lactoferrin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must meet all of the following criteria to be eligible for participation:
- Women, 18 - 40 years of age
- No changes in hormonal contraception use in the past 6 months
- Regular or mildly irregular cycles (24-45 days) for the past 3 months
- In the majority (>3) of menstrual cycles over the past 6 months, experience menstrual cramps on a pain scale of at least 4 out of 10 (1=no pain at all and 10 = worst pain ever experienced)
- In the majority (>3) of menstrual cycles over the past 6 months, experience pain so significant that it requires over-the-counter pain medication for at least 2 days (on average) per period
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- In the majority (>3) of menstrual cycles over the past 6 months, experience at least one day per cycle where menstrual symptoms either interfere with work or school performance, limit normal daily activities or exercise, or lead to staying home, leaving early, or modifying plans
- Reports noticeable mood or physical changes in the 5-7 days before menses in most cycles (irritability, mood, bloating, breast tenderness, cravings, sleep changes, etc.)
- Generally healthy and free of diseases or disorders that impact functioning of the gastrointestinal system.
- No recent or acute infection in the past 30 days and no chronic systemic illness
- No psychiatric condition that, in the investigator's judgment, would impair consent capacity, protocol adherence, or valid completion of questionnaires.
- If psychiatric medication is used: stable regimen for ≥3 months with no anticipated changes during the study
- Body mass index (BMI) 18.5 to 32.5 kg/m2 (Inclusive)
- Non-smoker
- Agrees to not use any new vitamin, mineral, or dietary supplement product until after study completion and to not take any vitamins, minerals or dietary supplements 24 hours prior to the exercise test visits.
- Willing and able to maintain consistent diet and physical activity habits
- Willing and able to provide consent and comply with the protocol
- Access to a smartphone, electronic, or personal computer with access to the internet to allow for completion of all online instruments and study reporting
- Able to read and understand English at the 6th-grade level and sign the informed consent to participate in the study
- Willing to use reliable contraception or maintain sexual abstinence during the study
Who cannot join
- Participants will be excluded if any of the following apply:
- Current or prior diagnosis from a licensed medical provider of Premenstrual Dysphoric Disorder (PMDD) or Premenstrual Syndrome (PMS) requiring ongoing medical or psychiatric treatment.
- History of any food allergies or intolerances that could impact digestive outcomes and history of irritable bowel syndrome, inflammatory bowel disease (Crohn's, ulcerative colitis, celiac), gastroparesis, chronic constipation or diarrhea requiring medication, or GI surgery
- Has any of the following medical conditions: bleeding disorders, active heart or cardiovascular disease, uncontrolled high blood pressure (≥ 140/90 mmHg), renal or hepatic impairment/disease, Type I or II diabetes, any neurologic disease or disorder that may impact cognition or mood, unstable thyroid disease, chronic inflammatory conditions, immune disorders (such as HIV/AIDS), or any medical condition deemed exclusionary by the Principal Investigator (PI)
- Acute illness or infection within the past 30 days
- History of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
Show all 17Show fewer
- Recently started taking (within the past 90 days or has had their dosage adjusted in the past 90 days) antihypertensives, hypoglycemic medications, GLP1 agonists of any class or type, stimulatory asthma medications, or any other prescription or over-the-counter medication that confound the outcomes measured in this study
- Habitual use of anti-inflammatory medications for 30 days prior to providing consent
- Current or past diagnosis of bipolar I/II disorder, schizophrenia spectrum or other psychotic disorder; psychiatric hospitalization, suicidal ideation, attempt, or self-harm behavior in the past 12 months
- Initiation, discontinuation, or dose change of any psychotropic medication within the past 3 months, including antidepressants, anxiolytics, antipsychotics, mood stabilizers, stimulants, or sedative-hypnotics
- Subject has an allergy to any ingredients in the study product
- Subject has a history of drug or alcohol abuse in the past 12 months
- Excessive alcohol intake defined as greater than 7 drinks/week or binge episodes
- Any condition or abnormality that in the expert opinion of the PI, participation in the study would compromise the safety of the subject or the quality of the study data.
- Participating in or has participated in another research study within 30 days prior to the screening visit that could confound outcomes
- Currently pregnant or lactating
- Currently in prison, custody, or otherwise considered a ward of the state preventing their ability to free participate
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Alethios
San Francisco, California, 94104
Zeenia Framroze, (650) 208-8006
- Not yet recruiting
Alethios, Inc.
San Francisco, California, 94109
Zoe Benham, B.S. Bioengineering, (650) 206-8006, zoe@alethios.com
Zeenia Framroze, M.A., (650) 206-8006, zeenia@alethios.com
About this study
Official title: Dose-Response of Effera® Supplementation for Women's Health Outcomes
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:
Read more
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
Read the detailed description
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)
- Conditions
- Womens Health, Menstrual Symptoms
- Being tested
- Effera® (human equivalent lactoferrin), Placebo
- Keywords
- Lactoferrin, Menstrual health, Dysmenorrhea, Effera, Gastrointestinal symptoms, Mood, Quality of life
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effera® (human equivalent lactoferrin)Dietary supplement
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.
PlaceboOther
Matched placebo supplement identical in appearance and packaging to the active intervention, administered orally once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Placebo Comparator | Placebo comparator | Participants receive a matched placebo supplement daily for 12 weeks. Receives: Other: Placebo |
| Arm 2: Effera® 100 mg | Active comparator | Participants receive 100 mg of effera® (human equivalent lactoferrin) once daily for 12 weeks. Receives: Dietary Supplement: Effera® (human equivalent lactoferrin) |
| Arm 3: Effera® 200 mg (Split Dose) | Active comparator | Participants receive 200 mg of effera® daily, administered as two 100 mg doses, for 12 weeks Receives: Dietary Supplement: Effera® (human equivalent lactoferrin) |
| Arm 4: Effera® 300 mg | Active comparator | Participants receive 300 mg of effera® once daily for 12 weeks. Receives: Dietary Supplement: Effera® (human equivalent lactoferrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and monthly during the study (Weeks 4, 8, and 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Womens HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized assigment, double-blind administration, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helaina Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524270
- Sponsor's protocol ID
- HEL-001
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Peterson RD, van der Made J, Kaplan N, Donovan SM, Wang M, Dilger RN, Clark AJ. Effects of human lactoferrin (effera) at two doses versus bovine lactoferrin on the adult gut microbiome and fecal short-chain fatty acids: A randomized, double-blind trial. medRxiv preprint. DOI: https://doi.org/10.64898/2025.12.31.25343278.
Peterson RD, Guarneiri LL, Adams CG, Wilcox ML, Clark AJ, Rudemiller NP, Maki KC, Malinczak CA. A Randomized, Double-Blind, Controlled Trial to Assess the Effects of Lactoferrin at Two Doses vs. Active Control on Immunological and Safety Parameters in Healthy Adults. Int J Toxicol. 2025 Jan-Feb;44(1):12-28. doi: 10.1177/10915818241293723. Epub 2024 Oct 28.
PubMed 39465888Ueno HM, Yoshise RE, Sugino T, Kajimoto O, Kobayashi T. Effects of a Bovine Lactoferrin Formulation from Cow's Milk on Menstrual Distress in Volunteers: A Randomized, Crossover Study. Int J Mol Sci. 2016 May 31;17(6):845. doi: 10.3390/ijms17060845.
PubMed 27258249Kowalczyk P, Kaczynska K, Kleczkowska P, Bukowska-Osko I, Kramkowski K, Sulejczak D. The Lactoferrin Phenomenon-A Miracle Molecule. Molecules. 2022 May 4;27(9):2941. doi: 10.3390/molecules27092941.
PubMed 35566292
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response of Effera® Supplementation for Women's Health Outcomes
- ClinicalTrials.gov ID
- NCT07524270
- Acronym / sponsor ID
- HEL-001
- Conditions
- Womens Health, Menstrual Symptoms
- Keywords
- Lactoferrin, Menstrual health, Dysmenorrhea, Effera, Gastrointestinal symptoms, Mood, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Helaina Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized assigment, double-blind administration, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Placebo Comparator | Placebo comparator | Other: PlaceboParticipants receive a matched placebo supplement daily for 12 weeks. |
| Arm 2: Effera® 100 mg | Active comparator | Dietary Supplement: Effera® (human equivalent lactoferrin)Participants receive 100 mg of effera® (human equivalent lactoferrin) once daily for 12 weeks. |
| Arm 3: Effera® 200 mg (Split Dose) | Active comparator | Dietary Supplement: Effera® (human equivalent lactoferrin)Participants receive 200 mg of effera® daily, administered as two 100 mg doses, for 12 weeks |
| Arm 4: Effera® 300 mg | Active comparator | Dietary Supplement: Effera® (human equivalent lactoferrin)Participants receive 300 mg of effera® once daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Women, 18 - 40 years of age
- No changes in hormonal contraception use in the past 6 months
- Regular or mildly irregular cycles (24-45 days) for the past 3 months
- In the majority (>3) of menstrual cycles over the past 6 months, experience menstrual cramps on a pain scale of at least 4 out of 10 (1=no pain at all and 10 = worst pain ever experienced)
- In the majority (>3) of menstrual cycles over the past 6 months, experience pain so significant that it requires over-the-counter pain medication for at least 2 days (on average) per period
Key exclusion criteria (17 listed)
- Current or prior diagnosis from a licensed medical provider of Premenstrual Dysphoric Disorder (PMDD) or Premenstrual Syndrome (PMS) requiring ongoing medical or psychiatric treatment.
- History of any food allergies or intolerances that could impact digestive outcomes and history of irritable bowel syndrome, inflammatory bowel disease (Crohn's, ulcerative colitis, celiac), gastroparesis, chronic constipation or diarrhea requiring medication, or GI surgery
- Has any of the following medical conditions: bleeding disorders, active heart or cardiovascular disease, uncontrolled high blood pressure (≥ 140/90 mmHg), renal or hepatic impairment/disease, Type I or II diabetes, any neurologic disease or disorder that may impact cognition or mood, unstable thyroid disease, chronic inflammatory conditions, immune disorders (such as HIV/AIDS), or any medical condition deemed exclusionary by the Principal Investigator (PI)
- Acute illness or infection within the past 30 days
- History of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Arm 2: Effera® 100 mg, Arm 3: Effera® 200 mg (Split Dose), Arm 4: Effera® 300 mg |
| PlaceboMatched placebo supplement identical in appearance and packaging to the active intervention, administered orally once daily for 12 weeks. | Other | Arm 1: Placebo Comparator |
Primary outcome
Change in menstrual symptoms (MSQ-24 score)
Time frame: Baseline, Week 4, Week 8, and Week 12
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.
4 secondary outcomes
Change in global health (PROMIS Global Health-10)
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in psychological distress (PHQ-4)
Time frame: Weekly from Baseline through Week 12
Change in gastrointestinal symptoms (PROMIS-GI Short Form)
Time frame: Baseline, Week 4, Week 8, and Week 12
Change in menstrual cycle-specific symptoms
Time frame: Baseline and monthly during the study (Weeks 4, 8, and 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- BackgroundPeterson RD, van der Made J, Kaplan N, Donovan SM, Wang M, Dilger RN, Clark AJ. Effects of human lactoferrin (effera) at two doses versus bovine lactoferrin on the adult gut microbiome and fecal short-chain fatty acids: A randomized, double-blind trial. medRxiv preprint. DOI: https://doi.org/10.64898/2025.12.31.25343278.
- Background: PubMed 39465888Peterson RD, Guarneiri LL, Adams CG, Wilcox ML, Clark AJ, Rudemiller NP, Maki KC, Malinczak CA. A Randomized, Double-Blind, Controlled Trial to Assess the Effects of Lactoferrin at Two Doses vs. Active Control on Immunological and Safety Parameters in Healthy Adults. Int J Toxicol. 2025 Jan-Feb;44(1):12-28. doi: 10.1177/10915818241293723. Epub 2024 Oct 28.
- Background: PubMed 27258249Ueno HM, Yoshise RE, Sugino T, Kajimoto O, Kobayashi T. Effects of a Bovine Lactoferrin Formulation from Cow's Milk on Menstrual Distress in Volunteers: A Randomized, Crossover Study. Int J Mol Sci. 2016 May 31;17(6):845. doi: 10.3390/ijms17060845.
- Background: PubMed 35566292Kowalczyk P, Kaczynska K, Kleczkowska P, Bukowska-Osko I, Kramkowski K, Sulejczak D. The Lactoferrin Phenomenon-A Miracle Molecule. Molecules. 2022 May 4;27(9):2941. doi: 10.3390/molecules27092941.
- Eligibility screening survey for this decentralized trialLink provided by the sponsor.
- Individual participant dataSharing planned: 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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Overweight, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effera® (human equivalent lactoferrin) in people with Womens Health and Menstrual Symptoms, run by Helaina Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chad Kerksick, PhD ((650) 206-8006, chad.kerksick@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in menstrual symptoms (MSQ-24 score) (time frame: Baseline, Week 4, Week 8, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07524270, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.