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NCT00904709
The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders
Phase 4 trial testing tranexamic acid in Menorrhagia in 249 participants. Completed in 1 March 2014.
1 March 2014
Quick facts
| Lead sponsor | K. Sue Robinson |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 249 |
| Start date | 19 October 2009 |
| Primary completion | 1 March 2014 |
| Estimated completion | 1 March 2014 |
Drugs / interventions tested
- tranexamic acid (Tranexamic Acid) — full drug profile →
Conditions studied
- Menorrhagia — all drugs for Menorrhagia →
Sponsor
K. Sue Robinson
Who can join
Adults 15 to 50, female only, with Menorrhagia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Many women have heavy periods and this can be associated with low blood, tiredness and inability to carry out normal activities. Approximately 10-30% of these women will have an underlying bleeding disorder. There is a drug called tranexamic acid which is commonly used and is effective in reducing menstrual flow. However, up to 1/3 of women have side effects and they are more common at higher doses. In the medical literature, there are different dosing schedules and there is one commonly recommended in Canada. Women with underlying bleeding disorders may require higher doses of this medication compared to those who do not. In this study, the investigators want to find the lowest effective dose of tranexamic acid for girls and women with heavy periods who have bleeding disorders and the investigators think this will be lower then the usual recommended dose. If the investigators' results support this, it may contribute to changing how the investigators presently prescribe this medication and may provide a better option for women with heavy periods in particular those with bleeding disorders. The investigators have just started a Women with Bleeding Disorders Clinic and hope that this project will lead to better care for the patients and more research in the future.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00904709
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Related trials
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Trials testing the same drug.
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- NCT05053867 — A Randomized Controlled Trial of Inhaled Tranexamic Acid for the Treatment of Pulmonary Hemorrhage in Cancer Patients · Phase 3 · recruiting
- NCT04625530 — Perioperative Management in Gynaecological Carcinoma Surgery · Phase 3 · withdrawn
- NCT04419246 — The Effect of Intravenous Tranexamic Acid and Interscalene Block Applied on Shoulder Arthroscopy · NA · unknown
Other recruiting trials for Menorrhagia
Currently open trials in the same condition.
- NCT07378098 — to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia · Phase 3 · recruiting
- NCT05922657 — A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00904709 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by K. Sue Robinson
- Last refreshed: 18 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00904709.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing