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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Duramed Research

Current Primary Outcome: Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding. [ Time Frame: Throughout study period ]

Original Primary Outcome: Proportion of patients who have received 10 days of treatment and reported withdrawal bleeding.

Current Secondary Outcome: Time to onset, duration, and severity of withdrawal bleeding. [ Time Frame: Throughout study ]

Original Secondary Outcome: Time to onset, duration, and severity of withdrawal bleeding.

Information By: Teva Pharmaceutical Industries

Dates:
Date Received: September 13, 2005
Date Started: September 2005
Date Completion:
Last Updated: July 29, 2014
Last Verified: May 2014