NCT00152295

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Abbott · Industry
• Sex: Female
• Age: 48 Years – 65 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Postmenopause

Interventions

Type	Name	Description
DRUG	Asoprisnil/Premarin	10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months

Timeline

• Start date: 2001-04-01
• Primary completion: 2001-12-01
• Completion: 2001-12-01
• First posted: 2005-09-09
• Last updated: 2008-05-29