Efficacy and Safety of XP12B in Women With Menorrhagia

Ferring

Status and phase: Completed; Phase 3

Conditions: Menorrhagia; Heavy Menstrual Bleeding

Treatments: Drug: Placebo tablets; Drug: Tranexamic acid tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401193

XP12B-MR-301

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: 304 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 for birth control

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

304 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Tranexamic acid tablets

Drug: Tranexamic acid tablets

2

Experimental group

Treatment:

Drug: Tranexamic acid tablets

Drug: Tranexamic acid tablets

3

Placebo Comparator group

Treatment:

Drug: Placebo tablets