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Effera® for Menstrual Symptoms in Women

This study is looking at whether a supplement called Effera® (a human equivalent lactoferrin) can help improve menstrual symptoms, mood, and overall well-being in healthy women aged 18-40. Researchers want to see if Effera® reduces the severity of menstrual symptoms and improves mood and gut issues. They will compare three different doses of Effera® (100 mg, 200 mg, or 300 mg daily) to a placebo (a supplement that looks the same but has no active ingredient). You might be able to join if you are a woman between 18 and 40 years old, have regular or mildly irregular periods, and experience menstrual cramps. The study is currently unclear about its recruitment status.

Study design
This is a randomized, double-blind, placebo-controlled study with 160 participants. You would be randomly assigned to one of four groups: placebo, 100 mg Effera®, 200 mg Effera®, or 300 mg Effera®.
What's involved
You would take your assigned supplement daily for 12 weeks. You will also complete online questionnaires about your symptoms and health approximately every four weeks.
Compensation
Not stated in the trial record.
Follow-up
Your menstrual symptoms will be measured at Baseline, Week 4, Week 8, and Week 12, which is the end of the study period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07524270

Effera Dose Response: Women's Health

Recruiting
NAAges 18–40Interventional
Helaina Inc.
~160 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Effera® (human equivalent lactoferrin)Placebo

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in menstrual symptoms (MSQ-24 score)
Measured over Baseline, Week 4, Week 8, and Week 12

Conditions

Womens Health
Menstrual Symptoms

Explore related trials

DysmenorrheaWomen's Health

NCT07524270

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Alethios

    San Francisco, Californiastudy coordinator listed

    Recruiting

  • Alethios, Inc.

    San Francisco, Californiastudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Chad Kerksick, PhD
[email protected]
(650) 206-8006
Email the study team

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Eligibility criteria

Inclusion

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
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

Exclusion

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.
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

What this trial measures

  • Change in menstrual symptoms (MSQ-24 score)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.