Suspended

LovenoxA Randomized, Controlled, Open Label Study of the Efficacy and Safety of the Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin) Versus HeparinTM (Unfractionated Heparin) for Prevention of Venous Thromboembolism (VTE) in Gynecologic Oncology Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Enoxaparin, Heparin

Drug
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: October 2009
See protocol details

Summary

Principal SponsorNational Guard Health Affairs
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2009

Actual date on which the first participant was enrolled.

This study is a phase IIIB, randomized, open label, non-comparative controlled trial, and prospectively enrolling 150 females to assess the efficacy and safety of the Enoxaparin (Group A) and Unfractionated Heparin (Group B) for Gynecologic Oncology Patients In the Kingdom of Saudi Arabia who required surgery or admission for the prevention of VTE. Patients who meet the Inclusion Criteria and signed an informed consent will be randomly assigned to 1 of the 2 treatment groups (Group A or Group B). Subjects will be assigned consecutive study numbers according to a predetermined random code generated by the Biostatistician. The randomisation will be based on a 1:1 ratio.

Official TitleA Randomized, Controlled, Open Label Study of the Efficacy and Safety of the Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin) Versus HeparinTM (Unfractionated Heparin) for Prevention of Venous Thromboembolism (VTE) in Gynecologic Oncology Patients
NCT01356329
Principal SponsorNational Guard Health Affairs
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: 1. Cancer patients aged 18 years or older were admitted with diagnosis of malignancy or suspension of malignancy and going for major surgery. 2. Patient with the following conditions: 1. Any patient were admitted with diagnosis of Gynecologic malignancy \& going for major surgery such as laparotomies \& abdominal hysterectomy OR 2. All staging laparotomies done for suspected ovarian malignancy by either ultrasound finding or tumor markers (raised CA 125) \& found to be either borderline or benign ovarian tumor 3. Signed the Informed Consent Form Exclusion Criteria: 1 Renal failure assessed by serum creatinine \> 2.0mg/dL (180 mmol/L) 2. Patients on anticoagulant treatment in the previous 6 months 3. Bleeding disorders or platelet count \< 80x109/L 4. Known hypersensitivity to unfractionated heparin or LMWHs 5. Pregnant women 6. Obese patients with body mass index ≥ 47

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Group B:HeparinTM (Unfractionated Heparin)

Group II

Experimental
Group A : Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

King Abdul Aziz Medical City for National Guard Health Affairs

Riyadh, Saudi ArabiaOpen King Abdul Aziz Medical City for National Guard Health Affairs in Google Maps
SuspendedOne Study Center