Effera doses to reduce menstrual cramps and improve mood

Dose-Response of Effera® Supplementation for Women's Health Outcomes

This study tests whether taking different doses of Effera (a lactoferrin supplement) daily for 12 weeks reduces menstrual cramps and improves mood, gastrointestinal symptoms, and overall well‑being in women ages 18–40.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Helaina Inc. (Industry-sponsored)
• Locations: 2 sites (San Francisco, California and 1 other locations)
• Trial ID: NCT07524270 on ClinicalTrials.gov

What this trial studies

This is a randomized, double‑blind, placebo‑controlled trial that assigns eligible participants equally to one of four arms (placebo, 100 mg Effera, 300 mg Effera, or two 100 mg doses daily) and follows them for 12 weeks of supplementation. Participants complete baseline assessments, then online questionnaires about menstrual symptoms, mood, gastrointestinal health, and quality of life roughly every four weeks, with an option to share wearable sleep and activity data. Randomization uses simple ABAB allocation with equal group sizes and all participants and study staff are blinded to assignment. Participants may stop at any time and the protocol targets otherwise healthy women with regular or mildly irregular cycles who experience moderate-to‑severe period pain.

Who should consider this trial

Good fit: Women age 18–40 with regular or mildly irregular cycles who in most of their past cycles had menstrual cramps rated ≥4/10, used OTC pain relief for at least two days per period, and who have had no changes in hormonal contraception in the past six months.

Not a fit: People outside the 18–40 age range, those without significant menstrual pain, those with major medical causes of pelvic pain, recent contraception changes, pregnancy, or lactation are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, Effera could provide a nonprescription supplement option that lowers menstrual pain and improves mood and daily function for some women.

How similar studies have performed: Lactoferrin has some prior small studies suggesting anti‑inflammatory and gastrointestinal benefits, but using a human‑equivalent lactoferrin supplement specifically for menstrual pain and mood is relatively novel and not well established.

Eligibility criteria

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

Where this trial is running

San Francisco, California and 1 other locations

• Alethios — San Francisco, California, United States (Recruiting)
• Alethios, Inc. — San Francisco, California, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Chad Kerksick, PhD

Conditions Womens Health; Menstrual Symptoms; Lactoferrin; Menstrual health; Dysmenorrhea; Effera; Gastrointestinal symptoms; Mood