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Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secrectory Conversion - Article


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Theophylline Tablets or Capsules

Accurbron; Aquaphyllin; Asmalix; Bronkodyl; Elixomin; Elixophyllin; Lanophyllin; Quibron-T Dividose; Slo-Phyllin; Theoclear-80; Theolair; Theostat 80

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

This study is currently recruiting patients.
Verified by Solvay Pharmaceuticals September 2005

Sponsored by: Solvay Pharmaceuticals
Information provided by: Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00160199

Purpose

To evaluate the efficacy of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea
Condition Intervention Phase
Secondary Amenorrhea
  Drug: progesterone
 Phase IV

MedlinePlus consumer health information 

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

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

Eligibility

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Female
Criteria

Inclusion Criteria:

Women 18-45 with secondary amenorrhea, Serum FSH ≤ 5 IU/L or ≥20 IU/L, serum estradiol ≤100 pg/ml. serum prgesterone ≤1 ng/ml. Normal serum DHEA, prolactin, testosterone, TSH and thyroxine

Exclusion Criteria:

Primary Amenorrhea, Asherman''''s syndrome,peanut allergy, allergy to progestational steroids,

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00160199

Barbara Parker       barbara.parker@solvay.com

Alabama
      Site 41, Montgomery,  Alabama,  United States; Recruiting
See central contact

      Site 29, Mobile,  Alabama,  United States; Recruiting
See central contact

Arizona
      Site 26, Tucson,  Arizona,  United States; Recruiting
See central contact

Arkansas
      Site 5, Jonesboro,  Arkansas,  United States; Recruiting
See central contact

California
      Site 10, San Diego,  California,  United States; Recruiting
See central contact

      Site 17, Encinitas,  California,  United States; Recruiting
See central contact

      Site 39, Carmichael,  California,  United States; Recruiting
See central contact

Connecticut
      Site 3, Groton,  Connecticut,  United States; Recruiting
See central contact

      Site 9, Waterbury,  Connecticut,  United States; Recruiting
See central contact

      Site 22, New Britain,  Connecticut,  United States; Recruiting
See central contact

      Site 42, Avon,  Connecticut,  United States; Recruiting
See central contact

      Site 37, West Hartford,  Connecticut,  United States; Recruiting
See central contact

Florida
      Site 1, West Palm Beach,  Florida,  United States; Recruiting
See central contact

      Site 14, Aventura,  Florida,  United States; Recruiting
See central contact

      Site 30, West Palm Beach,  Florida,  United States; Recruiting
See central contact

      Site 40, Clearwater,  Florida,  United States; Recruiting
See central contact

Georgia
      Site 43, Powder Springs,  Georgia,  United States; Recruiting
See central contact

Illinois
      Site 12, Chicago,  Illinois,  United States; Recruiting
See central contact

      Site 36, Champaign,  Illinois,  United States; Recruiting
See central contact

Louisiana
      Site 6, Baton Rouge,  Louisiana,  United States; Recruiting
See central contact

Maryland
      Site 7, Baltimore,  Maryland,  United States; Recruiting
See central contact

Missouri
      Site 2, St. Louis,  Missouri,  United States; Recruiting
See central contact

Nevada
      Site 16, Reno,  Nevada,  United States; Recruiting
See central contact

North Carolina
      Site 15, Winston Salem,  North Carolina,  United States; Recruiting
See central contact

      Site 23, New Bern,  North Carolina,  United States; Recruiting
See central contact

      Site 28, Winston Salem,  North Carolina,  United States; Recruiting
See central contact

Ohio
      Site 33, Cincinnati,  Ohio,  United States; Recruiting
See central contact

Pennsylvania
      Site 32, Erie,  Pennsylvania,  United States; Recruiting
See central contact

      Site 38, Pottstown,  Pennsylvania,  United States; Recruiting
See central contact

South Carolina
      Site 13, Greenville,  South Carolina,  United States; Recruiting
See central contact

Texas
      Site 8, Conroe,  Texas,  United States; Recruiting
See central contact

      Site 11, Corpus Christi,  Texas,  United States; Recruiting
See central contact

      Site 34, Houston,  Texas,  United States; Recruiting
See central contact

      Site 24, San Antonio,  Texas,  United States; Recruiting
See central contact

      Site 27, Houston,  Texas,  United States; Recruiting
See central contact

Utah
      Site 35, Salt Lake City,  Utah,  United States; Recruiting
See central contact

Virginia
      Site 19, Norfolk,  Virginia,  United States; Recruiting
See central contact

Washington
      Site 4, Seattle,  Washington,  United States; Recruiting
See central contact

Study chairs or principal investigators

Global Clinical Director Solvay,  Study Director,  Solvay Pharmaceuticals   

More Information

Study ID Numbers:  S168.4.002
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00160199
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005


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Page Updated: June 1, 2005
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