160 Participants NeededMy employer runs this trial

Effera for Period Cramps

Recruiting at 1 trial location
CK
Overseen ByChad Kerksick, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a supplement called effera® can reduce period cramps and improve mood and overall well-being for women. Researchers will compare three different doses of effera® to a placebo to determine the most effective option. Women with regular or mildly irregular menstrual cycles who experience significant cramping that affects daily life may be suitable candidates for this trial. Participants will take the supplement or placebo daily for 12 weeks and complete online questionnaires about their symptoms and health. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance women's health and well-being.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on psychiatric medication, your regimen must be stable for at least 3 months with no changes expected during the study. Also, you should not start any new vitamin, mineral, or dietary supplements during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lactoferrin, the main ingredient in effera®, is generally safe for people. One study found that lactoferrin from cow's milk improved mood symptoms in women with menstrual discomfort without causing significant side effects. Another study reported no major safety issues even at doses much higher than those in effera®.

No serious side effects have been reported at doses similar to those used in this trial, suggesting that effera® is likely safe for most people. However, individual reactions can vary with any supplement. Consulting a healthcare provider is always advisable if there are concerns about trying a new treatment.12345

Why are researchers excited about this trial's treatment?

Researchers are excited about Effera® because it introduces a unique approach to managing period cramps. Unlike standard pain relief treatments like NSAIDs (e.g., ibuprofen), Effera® utilizes human equivalent lactoferrin, a protein with potential anti-inflammatory properties. Additionally, Effera® offers flexibility in dosing, with options ranging from 100 mg to 300 mg, including a split-dose regimen, allowing for tailored treatment to individual needs. This novel mechanism and customizable dosing could provide an effective alternative for those seeking more than temporary symptom relief.

What evidence suggests that this trial's treatments could be effective for period cramps?

Research has shown that effera®, a supplement similar to the natural protein lactoferrin, might alleviate menstrual symptoms. Studies suggest that lactoferrin can lower inflammation, potentially reducing period pain. Some research also indicates that lactoferrin enhances iron absorption, which may boost energy and improve mood. Effera® is absorbed more effectively than other iron supplements, possibly offering additional benefits. Although more research is needed, these early findings are promising for those experiencing menstrual discomfort. Participants in this trial will receive varying dosages of Effera® or a placebo to evaluate its effectiveness.12678

Are You a Good Fit for This Trial?

This trial is for women aged 18-40 who are generally healthy, have regular or mildly irregular periods, and experience moderate to severe period cramps that often interfere with daily life. Participants should not have had recent infections, major health issues, or changes in hormonal birth control in the past 6 months.

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.
See 7 more

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®

Trial Overview

The study tests if a lactoferrin supplement (effera®) can reduce menstrual symptoms and improve mood compared to a placebo. Participants take either effera® at different doses or a placebo daily for 12 weeks and report on their symptoms through online surveys.

How Is the Trial Designed?

4

Treatment groups

Active Control

Placebo Group

Group I: Arm 4: Effera® 300 mgActive Control1 Intervention
Group II: Arm 3: Effera® 200 mg (Split Dose)Active Control1 Intervention
Group III: Arm 2: Effera® 100 mgActive Control1 Intervention
Group IV: Arm 1: Placebo ComparatorPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Helaina Inc.

Lead Sponsor

Citations

Effera Dose Response: Women's Health | GoodDay

The goal of this clinical trial is to learn if a human equivalent lactoferrin supplement (effera®) can improve menstrual symptoms, mood, and

Nonsteroidal anti‐inflammatory drugs for dysmenorrhoea - PMC

Among women with primary dysmenorrhoea, NSAIDs were more effective for pain relief than placebo (OR 4.37, 95% CI 3.76 to 5.09; 35 RCTs, I 2 = 53%, low quality ...

How effera® Lactoferrin Supports Every Stage of Your Life

Iron needs shift at every stage of a woman's life. See why lactoferrin outperforms ferrous sulfate from periods to pregnancy to menopause.

A Randomized, Double-Blind, Controlled Trial to Assess the ...

These results show that under the conditions of the protocol, no increased anti-hLF antibodies or adverse events were identified following ingestion of effera™ ...

Effects of Human Lactoferrin (effera®) at Two Doses versus ...

These results demonstrate that both HD and LD effera® supplementation maintained the microbiome diversity of healthy adults after the 28-day ...

Effects of a Bovine Lactoferrin Formulation from Cow's Milk on ...

The results indicate that FeLf can provide a beneficial effect on the psychological symptoms in women affected by menstrual distress.

Dietary supplements for dysmenorrhoea - Pattanittum, P

Comparison of the effectiveness of combination of fennel extract/vitamin E with ibuprofen on the pain intensity in students with primary dysmenorrhea. Iranian ...

369950f8-1757-4ef5-96bd-8f46fec3e98f.xml

... mg/kg/day (300 times the MRHD), a dose in which maternal toxicity was observed (effects on body weight gain). A NOAEL for maternal toxicity was 100 mg/kg ...