NCT03772366: GENB-OAB

Genital Haemorrhage in Woman of Childbearing Age Treated for Venous Thromboembolism Disease : Comparison According to Oral Anticoagulant and Impact on Quality of Life

Status unknown Last updated 30 November 2023

What this trial tests

trial in Genital Haemorrhage in 453 participants. Status unknown.

Timeline

1 June 2019

Primary endpoint
31 December 2021

31 January 2024

Quick facts

Lead sponsor	Assistance Publique Hopitaux De Marseille
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	453
Start date	1 June 2019
Primary completion	31 December 2021
Estimated completion	31 January 2024
Sites	1 location across France

Conditions studied

• Genital Haemorrhage — all drugs for Genital Haemorrhage →

Sponsor

Assistance Publique Hopitaux De Marseille — full company profile →

Who can join

18 and older, female only, with Genital Haemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Little data are available on the genital haemorrhages in woman of childbearing age treated for venous thromboembolic disease by oral anticoagulant, especially the impact on the quality of life. A recent systematic review in 2016 described for the first time in patients with venous thromboembolic a lower incidence in men of major haemorrhages and minor haemorrhages but clinically significant compared with women (5,3% and 7,9% respectively; RR: 0,635, 95%CI 0,54-0,74 ; p\<0,001). It appears that this difference is related to genital haemorrhages and some direct oral anticoagulants are more associated with hemorrhagic surge. In post-hoc analyzes of phases III trials, rivaroxaban was most of the time associated with genital haemorrhages compared to vitamine K antagonists, effect not found with apixaban. Four other retrospective studies seem to find the same conclusions with a higher haemorrhagic risk with the rivaroxaban than with vitamine K antagonist or apixaban.

However, haemorrhagic risk is defined in these studies with criteria of severity (anemia, transfusion, use of a health professional, menstrual periods of more than 8 days, inter mentrual bleeding, presence of blood clots) and these studies do not take into account of minor haemorrhages that may affect on the quality of life and asthenia due to anemia.

Our objective is : 1- studying the proportion of women with abnormal genital haemorrhages among women of childbearing age treated for venous thromboembolism disease by oral anticoagulant including using a semi quantitative score of menorrhagia. 2- To compare this proportion according to the three molecules of oral anticoagulants (antivitamin K, rivaroxaban and apixaban) and compare the molecules two by two and 3- to evaluate the impact of these haemorrhages on the quality of life. Our study would have a control group of women of childbearing age followed in vascular medicine for superficial venous insufficiency without thrombosis and without oral anticoagulant because the proportion of genital haemorrhages in women of childbearing age in PACA region is not known.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Abnormal uterine bleeding in users of rivaroxaban and apixaban.
   Jacobson-Kelly AE, Samuelson Bannow BT. · · 2020 · cited 14× · PMID 33275697 · DOI 10.1182/hematology.2020000166
2. Prevalence of abnormal uterine bleeding and quality of life after venous thromboembolism by oral anticoagulant use: the GENB-OAC Study.
   Sarlon-Bartoli G, Leclercq B, Trillot N, Mahé I, et al · · 2026 · PMID 41658977 · DOI 10.1016/j.rpth.2025.103328