Efficacy and 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; Drug: Placebo tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00386308

XP12B-MR-303

Details and patient eligibility

About

The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.

Enrollment: 196 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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196 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Tranexamic acid tablets

2

Placebo Comparator group

Treatment:

Drug: Placebo tablets