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

Abbott18 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postmenopause

Interventions

Asoprisnil/PremarinDRUG

10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months

Eligibility

Sex: FEMALEMin age: 48 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.

Time frame: Throughout Study

The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System

Time frame: Months 3,6

Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound.

Time frame: Months 3,6

Secondary Outcomes

Frequency and amount of vaginal bleeding assessed via daily diary.

Time frame: Throughout study

Frequency and severity of hot flushes assessed via daily diary.

Time frame: Throughout study

Mean change from baseline in endocrine determinations.

Time frame: Months 2,4,and 6

Global efficacy question

Time frame: Month 6

Data from ClinicalTrials.gov

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