Effera Dose Response: Women's Health

Conditions

• Menstrual Symptoms
• Womens Health

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 40 Years

Healthy Volunteers

Accepted

Interventions

• Effera® (human equivalent lactoferrin) — DIETARY_SUPPLEMENT
  Effera® 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
  Matched placebo supplement identical in appearance and packaging to the active intervention, administered orally once daily for 12 weeks.

Study Details

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

Key Dates

Start date

Apr 30, 2026

Status verified

Apr 2026

Primary completion

Nov 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

160 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Placebo Comparator: Arm 1: Placebo Comparator
  Participants receive a matched placebo supplement daily for 12 weeks.
• Active Comparator: Arm 2: Effera® 100 mg
  Participants receive 100 mg of effera® (human equivalent lactoferrin) once daily for 12 weeks.
• Active Comparator: Arm 3: Effera® 200 mg (Split Dose)
  Participants receive 200 mg of effera® daily, administered as two 100 mg doses, for 12 weeks
• Active Comparator: Arm 4: Effera® 300 mg
  Participants receive 300 mg of effera® once daily for 12 weeks.

Primary Outcome Measure

Change in menstrual symptoms (MSQ-24 score) [ Time Frame: Baseline, Week 4, Week 8, and Week 12 ]

Central Contacts

• Chad Kerksick, PhD
  (650) 206-8006
  [email protected]

Locations (2)

Find similar trials in San Francisco, CA

Related Studies

• The NaBu Effect on Menstruation in Women
  Recruiting · Magdy Milad, MD · Chicago, Illinois