UMIN-CTR Clinical Trial

Public title

Effect of the iron-lactoferrin complex on women with primary dysmenorrhea

Acronym

Effectiveness of the iron-lactoferrin complex on dysmenorrhea

Scientific Title

Effect of the iron-lactoferrin complex on women with primary dysmenorrhea

Scientific Title:Acronym

Effectiveness of the iron-lactoferrin complex on dysmenorrhea

Region

Japan

Condition

Primary dysmenorrhea

Classification by specialty

Psychosomatic Internal Medicine

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Primary dysmenorrhea is painful menstrual cramps without any evident pathology to account for them, and causes significant disruption in quality of life. Lactoferrin is a glycoprotein often occurred in mammalian grand such as cow's milk. Bovine lactoferrin shows analgestic effect via central nerve system in rodents and a few pilot studies in human. The aim of this trial is to investigate the effectiveness of the iron-lactoferrin complex on subjective symptoms associated with menstruation.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

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.

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

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 period. In the next menstruating period, two placebo tablets are administrated.

Interventions/Control_2

In a crossover design, two placebo tablets are orally administrated daily during the menstruating period, followed by the wash-out period until the next menstruating period. In the next menstruating period, two tablets containing the iron-lactoferrin complex are administrated.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

50

years-old

>

Gender

Female

Key inclusion criteria

Females from 20 years old to 49 years old having pain sensation during menstrual phase

Key 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

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Osami Kajimoto

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Medical Science on Fatigue

Zip code

Address

1-4-3 Asahimachi, Abeno-ku, Osaka

TEL

06-6645-6171

Email

kajimoto@med.osaka-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomohiro Sugino

Organization

Soiken Inc.

Division name

R&D Division

Zip code

Address

Senri Life Science Center 13F, 1-4-2 Shinsenri-higashimachi, Toyonaka, Osaka

TEL

06-6871-8888

Homepage URL

Email

sugino@soiken.com

Institute

Soiken Inc.

Institute

Department

Personal name

Organization

Megmilk Snow Brand Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

ふくだ内科クリニック（大阪府）

Date of disclosure of the study information

2014

Year

02

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2011

Year

10

Month

15

Day

Date of IRB

Anticipated trial start date

2012

Year

01

Month

14

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

02

Month

22

Day

Last modified on

2014

Year

02

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015014