drugset / Trial / NCT00401193
Efficacy and Safety of XP12B in Women With Menorrhagia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2006-11
- Primary completion
- 2008-05
- Completion
- 2008-05
Publications
- Freeman EW, Lukes A, VanDrie D, Mabey RG, Gersten J, Adomako TL. A dose-response study of a novel, oral tranexamic formulation for heavy menstrual bleeding. Am J Obstet Gynecol. 2011 Oct;205(4):319.e1-7. doi: 10.1016/j.ajog.2011.05.015. Epub 2011 May 14.
- Lukes AS, Muse K, Richter HE, Moore KA, Patrick DL. Estimating a meaningful reduction in menstrual blood loss for women with heavy menstrual bleeding. Curr Med Res Opin. 2010 Nov;26(11):2673-8. doi: 10.1185/03007995.2010.526098. Epub 2010 Oct 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tranexamic Acid | Small molecule | 1950 mg | Oral |
| Subject | Tranexamic Acid | Small molecule | 3900 mg | Oral |