Treatment of Uterine Fibroids With Asoprisnil(J867)

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00152269
First received: September 7, 2005
Last updated: May 27, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Leiomyoma
Menorrhagia
Metrorrhagia
Drug: Asoprisnil
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety (Including Bone Density Assessment) of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not have surgical/invasive intervention. [ Time Frame: Month 12 or Final Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention. [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Change from baseline in menstrual pictogram score. [ Time Frame: Final Month ] [ Designated as safety issue: No ]
  • Change from baseline in number of days with bleeding. [ Time Frame: Final Month ] [ Designated as safety issue: No ]
  • Change from baseline in hemoglobin concentration. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Percent change from baseline in volume of the largest fibroid. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Change from baseline in total symptom severity score and UFS-QOL total score. [ Time Frame: Final Visit ] [ Designated as safety issue: No ]
  • Cumulative percent of subjects who achieve amenorrhea. [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Enrollment: 475
Study Start Date: July 2002
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Asoprisnil
10mg Tablet, oral Daily for 12 months
Experimental: 2 Drug: Asoprisnil
25mg Tablet, oral Daily for 12 months
Placebo Comparator: 3 Drug: Placebo
Placebo, Tablet, oral Daily for 12 months

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premenopausal women
  • History of regular menstrual cycles (21-42 days)
  • Diagnosis of uterine fibroid(s)
  • Abnormal vaginal bleeding associated with uterine fibroids
  • Otherwise in good health
  • Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails
  • Negative pregnancy test
  • Agrees to Double-barrier method of contraception
  • Pap smear with no evidence of malignancy or pre-malignant changes
  • Endometrial biopsy with no significant histological disorder

Exclusion Criteria:

  • Any abnormal lab or procedure result the study-doctor considers important
  • Severe reaction(s) to or are currently using any hormone therapy
  • History of osteoporosis or other bone disease
  • Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months
  • History of Polycystic Ovary Syndrome or prolactinoma
  • MRI shows significant gynecologic disorder
  • Uterine size > 25 weeks gestation
  • Hemoglobin < 8 g/dL at Day -1
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152269

Sponsors and Collaborators
Abbott
Investigators
Study Chair: Medical Director Abbott
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cynthia Mattia-Goldberg, Abbott
ClinicalTrials.gov Identifier: NCT00152269     History of Changes
Other Study ID Numbers: M01-390
Study First Received: September 7, 2005
Last Updated: May 27, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Symptomatic Uterine Fibroids
Excessive Uterine Bleeding
Uterine Hemorrhage
asoprisnil

Additional relevant MeSH terms:
Leiomyoma
Menorrhagia
Metrorrhagia
Myofibroma
Connective Tissue Diseases
Genital Diseases, Female
Hemorrhage
Menstruation Disturbances
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Muscle Tissue
Pathologic Processes
Uterine Diseases
Uterine Hemorrhage

ClinicalTrials.gov processed this record on October 23, 2014