Primary dysmenorrhea
Conditions
Interventions
In a crossover design, two tablets containing the iron-lactoferrin complex are orally administrated daily during the menstruating period, followed by the wash-out period until the next menstruating pe
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Females from 20 years old to 49 years old having pain sensation during menstrual phase
Exclusion criteria
Exclusion criteria: 1) Subject having medical treatment in a hospital or clinic 2) Subject having treatment or previous history for serious cardiovascular, respiratory, endocrine, or metabolic disorders 3) Subject having any infectious diseases or their possibility 4) Subject who ended participation in another clinical trial less than 3 months before 5) Subject having cedar or cypress pollen allergy 6) Subject having a food allergy, specially dairy products 7) For female subjects: pregnancy or possibility of pregnancy, or intending to become pregnant during the study. 8) Subject who has had a blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months of the start of the present study 9) Subject deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is a combination of subjective measurements (Moos menstrual distress questionnaire, Visual rating scale, and Verbal rating scale) and an objective measurement (Finger-tip accelerated plethysmography) during a menstruating period. | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed