Effera Dose Response: Women's Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorHelaina Inc.
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Effera® (human equivalent lactoferrin)
Dietary supplementEffera® 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.
Placebo
Other interventionMatched placebo supplement identical in appearance and packaging to the active intervention, administered orally once daily for 12 weeks.
Treatment groups
160 Participants
are divided into 4 treatment groupsGroup A: Arm 1: Placebo ComparatorPlacebo comparator 1 intervention
Group B: Arm 2: Effera® 100 mgActive comparator 1 intervention
Group C: Arm 3: Effera® 200 mg (Split Dose)Active comparator 1 intervention
Group D: Arm 4: Effera® 300 mgActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 12Secondary outcomes
1
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 122
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 123
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 124
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)Other outcomes
1
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 periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov