A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women

May 27, 2008 updated by: Abbott

A Phase II Long-Term Extension Safety Study of J867 Administered With Estrogen to Postmenopausal Women

The objective of this study is to determine the long-term safety of asoprisnil 10 mg when administered to postmenopausal women with Premarin® 0.625 mg

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg tablets) when taken with Premarin® 0.625 mg, by postmenopausal women, for 6 months after an initial 12 weeks in Study M00-198. Pharmacodynamic effects to be assessed include uterine bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments will include clinical laboratory results, physical examination with vital signs, pelvic and breast examinations, ultrasound results, and adverse events.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Successful completion of study M00-198
  • Continued good general health
  • Negative urine pregnancy test

Exclusion Criteria:

  • History of known or suspected cancer other than basal cell carcinoma in last 5 years
  • History of reproductive endocrine disorder
  • Submucous or other symptomatic fibroid which would confound efficacy
  • Ovarian mass
  • Ongoing treatment with an excluded medication
  • Stenosis of the cervix
  • Any abnormal lab result the study-doctor considers significant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Asoprisnil/Premarin
10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.
Time Frame: Throughout Study
Throughout Study
The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System
Time Frame: Months 3,6
Months 3,6
Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound.
Time Frame: Months 3,6
Months 3,6

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency and amount of vaginal bleeding assessed via daily diary.
Time Frame: Throughout study
Throughout study
Frequency and severity of hot flushes assessed via daily diary.
Time Frame: Throughout study
Throughout study
Mean change from baseline in endocrine determinations.
Time Frame: Months 2,4,and 6
Months 2,4,and 6
Global efficacy question
Time Frame: Month 6
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

December 1, 2001

Study Completion (Actual)

December 1, 2001

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Estimate)

May 29, 2008

Last Update Submitted That Met QC Criteria

May 27, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M01-280

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe