Clinical Trial: Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion

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

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

Brief 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

Detailed Summary:
Sponsor: Solvay Pharmaceuticals

Current Primary Outcome:

  • Secretory Conversion of the Endometrium [ Time Frame: End of the study (Days 85) ]
    Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.
  • Number of Subjects With Withdrawal Bleeding [ Time Frame: After first and second cycle (cycle=28 days) ]
    This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.


Original Primary Outcome:

Current Secondary Outcome:

  • Maximum Intensity of Withdrawal Bleeding After Any Cycle [ Time Frame: Duration of withdrawal bleed ]
    The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy
  • The Duration of Withdrawal Bleeding After the First Treatment Cycle [ Time Frame: End of the first cycle of treatment (cycle=28 days) ]
    The numbers of days the subjects actually bled after the end of the first treatment cycle.
  • The Duration of Withdrawal Bleeding After Second Treatment Cycle [ Time Frame: End of the second cycle of treatment (cycle=28 days) ]
    The numbers of days the subjects actually bled after the end of the second treatment cycle
  • Time to Withdrawal Bleeding After First Treatment Cycle [ Time Frame: End of the first cycle of treatment (cycle=28 days) ]
    The number of days between the first cycle of treatment and the withdrawal bleeding.
  • Time to Withdrawal Bleeding After Second Treatment Cycle [ Time Frame: End of the second cycle of treatment (cycle=28 days) ]
    The number of days between the second cycle of treatment and the withdrawal bleeding


Original Secondary Outcome:

Information By: Solvay Pharmaceuticals

Dates:
Date Received: September 8, 2005
Date Started: November 2004
Date Completion:
Last Updated: June 30, 2010
Last Verified: June 2010