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”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Induction of complete secretory conversion of the endometrium and rate of withdrawal bleeding measured
  • Time Frame: 3 28-day cycles
    Safety Issue?: Yes

Secondary Measures

• Frequency and intensity of withdrawal bleeding
  • Time Frame: From termination of PROMETRIUM® therapy up to and including one week following the last dose for 3 28-day cycles
    Safety Issue?: Yes
• Number of days from last dose of study medication to the initiation of withdrawal bleeding
  • Time Frame: From last dose of study medication to inititation of withdrawal bleeding
    Safety Issue?: Yes
• Intensity of withdrawal bleeding episode
  • Time Frame: Duration of withdrawal bleed
    Safety Issue?: Yes
• The duration of withdrawal bleeding episode
  • Time Frame: Duration of withdrawal bleed
    Safety Issue?: Yes

Inclusion Criteria:

• Women 18-45 with secondary amenorrhea, serum progesterone =2 ng/ml
• Normal serum DHEA, prolactin, testosterone, TSH and thyroxine

Exclusion Criteria:

• Primary amenorrhea
• Asherman's syndrome
• Peanut allergy
• Allergy to progestational steroids

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Solvay Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Global Clinical Director Solvay Study Director Solvay Pharmaceuticals  

Overall Contact: Cindy Lane  cindy.lane@solvay.com

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00160199

Study ID Number: S168.4.002

ClinicalTrials.gov Identifier: NCT00160199

Health Authority: United States: Food and Drug Administration