Could a daily supplement ease period pain?
NCT ID NCT07524270
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a daily supplement called Effera® (a human-like lactoferrin protein) can reduce menstrual symptoms, improve mood, and boost overall well-being in women aged 18-40. Participants take either a low, medium, or high dose of Effera® or a placebo for 12 weeks and complete online questionnaires. The goal is to see if this natural protein can help with period-related discomfort.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Effera® (human equivalent lactoferrin supplement)
- What this could lead to
- If it works, this could offer a natural supplement option for reducing menstrual cramps and improving mood and quality of life.
- What could go wrong
- This is an early-stage trial with 160 participants, so results may not apply to everyone. The supplement may not outperform placebo, and individual responses can vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 * 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 Criteria: 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. * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Alethios
RECRUITINGSan Francisco, California, 94104, United States
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Alethios, Inc.
NOT_YET_RECRUITINGSan Francisco, California, 94109, United States
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