A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids

Menorrhagia Clinical Trial

Official title:

A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160381
• Other study ID #: M01-394
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: May 27, 2008
• Start date: September 2002
• Est. completion date: January 2005

Study information

• Verified date: May 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

• Leiomyoma
• Menorrhagia
• Metrorrhagia

Intervention

Drug:
• Asoprisnil
10mg Tablet, oral Daily for 12 months
• Asoprisnil
25 mg Tablet, oral Daily for 12 months
• Placebo
Tablet, oral Daily for 12 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.		Month 12 or Final Visit	No
Secondary	Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.		Month 6	No
Secondary	Change from baseline in menstrual pictogram score.		Final Month	No
Secondary	Change from baseline in number of days with bleeding.		Final Month	No
Secondary	Change from baseline in hemoglobin concentration.		Final Visit	No
Secondary	Percent change from baseline in volume of the largest fibroid.		Final Visit	No
Secondary	Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.		Final Visit	No
Secondary	Change from baseline in total symptom severity score and UFS-QOL total score.		Final Visit	No
Secondary	Cumulative percent of subjects who achieve amenorrhea.		Month 3	No