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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.


Phase 3
18 Years
N/A
Not Enrolling
Female
Leiomyoma, Menorrhagia, Metrorrhagia

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Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.

Outcome Time Frame:

Month 12 or Final Visit

Safety Issue:

No

Principal Investigator

Medical Director

Investigator Role:

Study Chair

Investigator Affiliation:

Abbott

Authority:

Canada: Health Canada

Study ID:

M01-394

NCT ID:

NCT00160381

Start Date:

September 2002

Completion Date:

January 2005

Related Keywords:

  • Leiomyoma
  • Menorrhagia
  • Metrorrhagia
  • Symptomatic Uterine Fibroids
  • Excessive Uterine Bleeding
  • Uterine Hemorrhage
  • asoprisnil
  • Leiomyoma
  • Myofibroma
  • Menorrhagia
  • Metrorrhagia

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