NCT00152282

A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women

A Phase II Pilot Study to Evaluate the Safety and Efficacy of J867 Administered With Estrogen to Postmenopausal Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (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 safety and effectiveness of 3 asoprisnil doses when administered to postmenopausal women with Premarin® 0.625 mg.

Detailed description

The objective of this study is to determine the safety and effectiveness of asoprisnil 5, 10, and 25 mg, compared to placebo, when administered to postmenopausal women, with Premarin® 0.625 mg, for 12 weeks. Pharmacodynamic effects to be assessed include 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

• Amenorrhea
• Postmenopause

Interventions

Type	Name	Description
DRUG	Asoprisnil/Premarin	Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
DRUG	Asoprisnil/Premarin	Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
DRUG	Asoprisnil/Premarin	Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
DRUG	Placebo and Premarin	Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks

Timeline

• Start date: 2000-09-01
• Primary completion: 2001-08-01
• Completion: 2001-08-01
• First posted: 2005-09-09
• Last updated: 2008-05-29