Effera for Period Cramps

Recruiting at 1 trial location

Overseen By Chad Kerksick, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Helaina Inc.

Must not be taking: Antidepressants, Antipsychotics, Mood stabilizers, others

Disqualifiers: PMDD, PMS, Diabetes, Cardiovascular disease, others

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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

Are You a Good Fit for This Trial?

Inclusion Criteria

I have not had a recent infection or ongoing serious illness.

* No psychiatric condition that, in the investigator's judgment, would impair consent capacity, protocol adherence, or valid completion of questionnaires.

I am a woman between 18 and 40 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive the assigned supplement (effera® or placebo) daily for 12 weeks and complete online questionnaires about menstrual symptoms, mood, and health

12 weeks

Weekly online assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Effera®

How Is the Trial Designed?

Group I: Arm 4: Effera® 300 mg Active Control 1 Intervention

Participants receive 300 mg of effera® once daily for 12 weeks.

Group II: Arm 3: Effera® 200 mg (Split Dose) Active Control 1 Intervention

Participants receive 200 mg of effera® daily, administered as two 100 mg doses, for 12 weeks

Group III: Arm 2: Effera® 100 mg Active Control 1 Intervention

Participants receive 100 mg of effera® (human equivalent lactoferrin) once daily for 12 weeks.

Group IV: Arm 1: Placebo Comparator Placebo Group 1 Intervention

Participants receive a matched placebo supplement daily for 12 weeks.

Who Is Running the Clinical Trial?

Helaina Inc.

Lead Sponsor