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New treatment option for Womens Health
Official title Effera Dose Response: Women's Health
ClinicalTrials.gov ID: NCT07524270
What this study is testing
- What it's testing
- 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?
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- History of any food allergies or intolerances that could impact digestive outcomes and history of irritable bowel syndrome, inflammatory bowel...
- Has any of the following medical conditions: bleeding disorders, active heart or cardiovascular disease, uncontrolled high blood pressure (≥ 140/90...
- Acute illness or infection within the past 30 days
- History of cancer (except localized skin cancer without metastases) within 5 years prior to screening.
See the full eligibility criteria
Who can join
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.