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Randomized Double-Blind Multicenter Placebo-Controlled Study of Tranilast in Patients with Dysmenorrhea

Randomized Double-Blind Multicenter Placebo-Controlled Study of Tranilast in Patients with Dysmenorrhea - Randomized Double-Blind Multicenter Placebo-Controlled Study of Tranilast in Patients with Dysmenorrhea

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015796
Enrollment
60
Registered
2014-12-01
Start date
2014-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysmenorrhea

Interventions

Tranilast administration of between 6 months placebo administration of between 6 months

Sponsors

Endometriosis / Tranilast Study Group
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) age is less than 45 years of age or 20 years of age at the time of obtaining informed consent, menstrual cycle is 25-38 days patients (2) patients with dysmenorrhea VAS is greater than or equal to 30mm (3) patients symptoms of dysmenorrhea has been controlled by only the use of N-saids, which has been determined to be controlled by only N-Saids throughout the study period (4) patients who do not wish to become pregnant during the study period (5) for participation in the study, patients consent document person was obtained

Exclusion criteria

Exclusion criteria: (1) age is less than 45 years of age or 20 years of age at the time of obtaining informed consent, menstrual cycle is 25-38 days patients (2) patients with dysmenorrhea VAS is greater than or equal to 30mm (3) patients symptoms of dysmenorrhea has been controlled by only the use of N-saids, which has been determined to be controlled by only N-Saids throughout the study period (4) patients who do not wish to become pregnant during the study period (5) for participation in the study, patients consent document person was obtained

Design outcomes

Primary

MeasureTime frame
VAS of dysmenorrhea

Secondary

MeasureTime frame
Dysmenorrhea score Lower abdominal pain during menstruation, low back pain, headache, degree of nausea Other than during menstruation pelvic pain VAS Serum CA125 concentration TTF (Time to Treatment Failure) (such as incidence of adverse events)

Countries

Japan

Contacts

Public ContactRitsuo Honda

Kumamoto University Hospital Department of Obstetrics and Gynecology

ritz@kumamoto-u.ac.jp096-373-5269

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026