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

Postmenopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152295
• Other study ID #: M01-280
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: May 27, 2008
• Start date: April 2001
• Est. completion date: December 2001

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2001
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 48 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postmenopause

Intervention

Drug:
• Asoprisnil/Premarin
10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System.		Throughout Study	Yes
Primary	The percentage of subjects in each endometrial biopsy diagnostic category summarized using SPRM Classification System		Months 3,6	Yes
Primary	Change from baseline in endometrial thickness (mm) as measured by transvaginal ultrasound.		Months 3,6	Yes
Secondary	Frequency and amount of vaginal bleeding assessed via daily diary.		Throughout study	No
Secondary	Frequency and severity of hot flushes assessed via daily diary.		Throughout study	No
Secondary	Mean change from baseline in endocrine determinations.		Months 2,4,and 6	No
Secondary	Global efficacy question		Month 6	No