NCT00196391

A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea

A Multicenter Study to Evaluate Induction of Withdrawal Bleeding After Administration of DR-2021 in Women With Secondary Amenorrhea

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Duramed Research · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo and oral micronized progesterone in inducing withdrawal bleeding in women with secondary amenorrhea.

Detailed description

In this multicenter trial patients will be randomized to receive DR-2021, oral micronized progesterone, and placebo to evaluate the effects on withdrawal bleeding in women with secondary amenorrhea. Patients will be treated for 10 days and study participation will be approximately 24 days. Patients will undergo a physical exam including a pelvic and breast exam. Patients will be required to complete bleeding and spotting information daily in a diary.

Conditions

• Amenorrhea

Interventions

Type	Name	Description
DRUG	DR-2021a	1 capsule daily for 10 days
DRUG	DR-2021b	1 capsule daily for 10 days
DRUG	DR-2021c	1 capsule daily for 10 days
DRUG	DR-2021d	1 capsule daily for 10 days
DRUG	DR-2021e	1 capsule daily for 10 days
OTHER	Placebo	1 matching placebo capsule for 10 days

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2005-09-20
• Last updated: 2014-07-30

Locations

27 sites across 1 country: United States