Safety Study of XP12B in Women With Menorrhagia

Ferring

Status and phase: Completed; Phase 3

Conditions: Menorrhagia; Heavy Menstrual Bleeding

Treatments: Drug: Tranexamic acid tablets (XP12B)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00113568

XP12B-MR-302

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.

Enrollment: 784 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with menorrhagia
• 18-49 years of age
• Regularly occuring menstrual periods

Exclusion criteria

• History or presence of clinically significant disease or abnormalities that might confound the study
• History of bilateral oophorectomy or hysterectomy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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784 participants in 1 patient group

XP12B (tranexamic acid tablets)

Experimental group

Treatment:

Drug: Tranexamic acid tablets (XP12B)