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

Completed · Phase 4

Conditions studied: Secondary Amenorrhea

In brief

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

Key facts

Study ID

NCT00160199

Run by

Solvay Pharmaceuticals

People needed

240

Starts

2004-11-01

Expected to finish

2009-02-01

Last updated by the study team

2010-07-07

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Primary amenorrhea
• Other medical conditions resulting in amenorrhea (e.g. Asherman's syndrome)
• Peanut allergy
• Allergy to progestational steroids

Where it is running

• Site 29 — Mobile, Alabama, United States
• Site 41 — Montgomery, Alabama, United States
• Site 26 — Tucson, Arizona, United States
• Site 5 — Jonesboro, Arkansas, United States
• Site 39 — Carmichael, California, United States
• Site 17 — Encinitas, California, United States
• Site 10 — San Diego, California, United States
• Site 42 — Avon, Connecticut, United States
• Site 3 — Groton, Connecticut, United States
• Site 22 — New Britian, Connecticut, United States
• Site 9 — Waterbury, Connecticut, United States
• Site 37 — West Hartford, Connecticut, United States
• Site 14 — Aventura, Florida, United States
• Site 40 — Clearwater, Florida, United States
• Site 1 — West Palm Beach, Florida, United States
• Site 30 — West Palm Beach, Florida, United States
• Site 46 — Atlanta, Georgia, United States
• Site 43 — Powder Springs, Georgia, United States
• Site 36 — Champaign, Illinois, United States
• Site 12 — Chicago, Illinois, United States
• Site 6 — Baton Rouge, Louisiana, United States
• Site 7 — Baltimore, Maryland, United States
• Site 2 — St Louis, Missouri, United States
• Site 16 — Reno, Nevada, United States
• Site 45 — New York, New York, United States

Full record on ClinicalTrials.gov

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