Study of Asoprisnil in the Treatment of Uterine Fibroids. | NCT00156156

Studies
Study of Asoprisnil in the Treatment of Uterine Fibroids.

NCT00156156

Sponsor

Abbott

Status

Completed

Last Update Posted

May 28, 2008Estimated

Enrollment

149Actual

Phase

Phase 3

Conditions

Fibroid Uterus
Leiomyoma
Menorrhagia
Metrorrhagia
Uterine Fibroids

Interventions

Asoprisnil
Asoprisnil

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Feb 2007Actual

Completion Date

Feb 2007Actual

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2008

Last Update Posted Date

May 28, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to determine the long-term safety of asoprisnil in women with abnormal uterine bleeding associated with uterine fibroids.

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 long-term safety of two asoprisnil doses (10 and 25 mg tablets) administered daily to women who received asoprisnil in one of the asoprisnil long-term studies (study C03-062 or study M01-391). The safety endpoints for this study will include the affects of asoprisnil on the endometrium, ovaries, bone (a subset of study M01-391 subjects), lipid profiles, adverse events, and changes from baseline lab values and vital signs.

Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

149Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Asoprisnil
2	Experimental		Drug: Asoprisnil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Asoprisnil	Drug	Asoprisnil 10 mg Tablet, oral Daily for up to 2 years	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long-term Safety.		Throughout 2 year treatment period

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in the monthly bleeding score and the number of days with bleeding.		Each Month
Change from baseline in hemoglobin, hematocrit, TIBC, ferritin and iron concentrations.		Months 3, 6, 9,12,15,18, 24

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women who have completed 12 months of active treatment in study M01-391 and Month 12 visit procedures Or completed 18 months of active treatment in study C03-062 and Month 18 visit procedures (with no more than a 14-day interruption in dosing from study C02-062 and this study) OR could not continue in a previous asoprisnil study, but are now eligible for retreatment
Otherwise in good health
Premenopausal based on Estrogen and FSH levels
Adequate endometrial biopsy with no significant histological disorder
Agrees to use double-barrier method of contraception

Exclusion Criteria:

Any abnormal lab or procedure result(s) the study-doctor considers important
History of a blood-clotting disorder
History of osteoporosis requiring treatment
Any invasive procedure(s) (D&C, etc) where a polyp was confirmed or a surgical or invasive procedure for uterine fibroids was performed during any previous asoprisnil study
Hemoglobin < 8.0 g/dL
Endometrial thickness ≥ 19 mm

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Director	Abbott	Study Chair

Condition Browse Module

MeSH Terms

ID	Term
D007889	Leiomyoma
D008595	Menorrhagia
D008796	Metrorrhagia
D014592	Uterine Hemorrhage

Ancestor Terms

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

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Browse Branches

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