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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00160459
Other study ID # M99-144
Secondary ID
Status Completed
Phase Phase 2
First received September 8, 2005
Last updated May 27, 2008
Start date May 2000
Est. completion date July 2001

Study information

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

Clinical Trial Summary

This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.


Description:

No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study


Recruitment information / eligibility

Status Completed
Enrollment 129
Est. completion date July 2001
Est. primary completion date July 2001
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 48 Years
Eligibility Inclusion Criteria:

- Women between 18 and 49 years of age

- Diagnosis of either 1 or more uterine fibroids

- History of regular menstrual cycles of 21 to 35 days in length.

Exclusion Criteria:

- Any abnormal lab result the study-doctor considers significant

- History of severe reaction to or current use of hormone therapy

- History of osteoporosis or other bone disease

- History of uterine artery embolization, cryomyolysis, or electrical myolysis

- Subject currently breast feeding

- Hemoglobin < 8 g/dL at baseline

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


Intervention

Drug:
Asoprisnil
5 mg Tablet, oral Daily for 12 weeks
Asoprisnil
10 mg Tablet, oral Daily for 12 weeks
Asoprisnil
25 mg Tablet, oral Daily for 12 weeks
Placebo
Tablet, oral Daily for 12 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Abbott

References & Publications (1)

Chwalisz K, Larsen L, Mattia-Goldberg C, Edmonds A, Elger W, Winkel CA. A randomized, controlled trial of asoprisnil, a novel selective progesterone receptor modulator, in women with uterine leiomyomata. Fertil Steril. 2007 Jun;87(6):1399-412. Epub 2007 F — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percent change from baseline in uterine volume and volume of the largest fibroid. Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6. No
Primary Duration of amenorrhea Day 1 to 1st post treatment menses No
Secondary Change from baseline in uterine size in gestational weeks. Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6 No
Secondary Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume. Week 12 and final visit No
Secondary Percentage of days with bleeding. Day 1 through end of 1st post-treatment menses No
Secondary Changes in hematologic and iron parameters. Baseline to each visit Yes
Secondary Uterine fibroid symptom improvement. Baseline to each visit No
Secondary Response to Global Efficacy Question regarding improvement in fibroid symptoms. Week 12 and Final Visit No
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