NCT00160199

Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion

Evaluation of Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding in Subjects With Secondary Amenorrhea

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea

Conditions

• Secondary Amenorrhea

Interventions

Type	Name	Description
DRUG	PROMETRIUM® 300 mg	300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles
DRUG	PROMETRIUM® 400 mg	400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles

Timeline

• Start date: 2004-11-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2005-09-12
• Last updated: 2010-07-07
• Results posted: 2010-06-02

Locations

42 sites across 1 country: United States