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
Qualifiers
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
Treatments tested in this trial
- Effera® (human equivalent lactoferrin)
- Placebo
Treatment groups
160 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov