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Efficacy and Safety of XP12B in Women With Menorrhagia

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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

Trial contacts and locations

83

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Data sourced from clinicaltrials.gov

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