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

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

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

• Secretory Conversion of the Endometrium
  • Time Frame: End of the study (Days 85)
    Safety Issue?: No
• Number of Subjects With Withdrawal Bleeding
  • Time Frame: After first and second cycle (cycle=28 days)
    Safety Issue?: No

Secondary Measures

• Maximum Intensity of Withdrawal Bleeding After Any Cycle
  • Time Frame: Duration of withdrawal bleed
    Safety Issue?: No
• The Duration of Withdrawal Bleeding After the First Treatment Cycle
  • Time Frame: End of the first cycle of treatment (cycle=28 days)
    Safety Issue?: No
• The Duration of Withdrawal Bleeding After Second Treatment Cycle
  • Time Frame: End of the second cycle of treatment (cycle=28 days)
    Safety Issue?: No
• Time to Withdrawal Bleeding After First Treatment Cycle
  • Time Frame: End of the first cycle of treatment (cycle=28 days)
    Safety Issue?: No
• Time to Withdrawal Bleeding After Second Treatment Cycle
  • Time Frame: End of the second cycle of treatment (cycle=28 days)
    Safety Issue?: No

Inclusion Criteria:

• Women with secondary amenorrhea
• Normal serum Dehydroepiandrosterone (DHEA), prolactin, testosterone, Thyroid
• Stimulating Hormone (TSH) and thyroxine

Exclusion Criteria:

• Primary amenorrhea
• Other medical conditions resulting in amenorrhea (e.g. 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 Investigator: Solvay Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Global Clinical Director Solvay Study Director Solvay Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

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