Clinical Trials Logo

Clinical Trial Summary

The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.


Clinical Trial Description

No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this study. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00160381
Study type Interventional
Source Abbott
Contact
Status Completed
Phase Phase 3
Start date September 2002
Completion date January 2005

See also
  Status Clinical Trial Phase
Completed NCT02824224 - Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) Phase 4
Withdrawn NCT01651468 - The Effect of the Nutraceutical "Hemofix" on the Coagulation System N/A
Recruiting NCT02616731 - Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD Phase 1/Phase 2
Terminated NCT02087228 - Evaluation of the Endometrial Cavity After Endometrial Ablation N/A
Withdrawn NCT00953641 - Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy Phase 3
Completed NCT01436903 - Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length Phase 4
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00156195 - Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids Phase 3
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Completed NCT02228174 - Sonography Guided Transcervical Ablation of Uterine Fibroids N/A
Terminated NCT01969396 - Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology N/A
Completed NCT00386308 - Efficacy and Safety Study of XP12B in Women With Menorrhagia Phase 3
Completed NCT00393198 - Bleeding Pattern and User Satisfaction During Second Consecutive MIRENA® in Contraception and Treatment of Menorrhagia Phase 4
Completed NCT00966264 - Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia Phase 3
Completed NCT00904709 - The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders Phase 4
Recruiting NCT03670680 - Efficiency of Lina LibrataTM System N/A
Completed NCT02584088 - Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation
Completed NCT02835391 - PerClot Compared to Usual Care in Gynaecology Procedures N/A
Completed NCT02304510 - Prevalence of Heavy Menstrual Bleeding in Female Population Living in Beijing
Completed NCT01197547 - Registry Study of Genesys HTA for Treatment of Menorrhagia N/A