Status:
COMPLETED
Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Secondary Amenorrhea
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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
Eligibility Criteria
Inclusion
- Women with secondary amenorrhea
- Normal serum Dehydroepiandrosterone (DHEA), prolactin, testosterone, Thyroid Stimulating Hormone (TSH) and thyroxine
Exclusion
- Primary amenorrhea
- Other medical conditions resulting in amenorrhea (e.g. Asherman's syndrome)
- Peanut allergy
- Allergy to progestational steroids
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00160199
Start Date
November 1 2004
End Date
February 1 2009
Last Update
July 7 2010
Active Locations (42)
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1
Site 29
Mobile, Alabama, United States
2
Site 41
Montgomery, Alabama, United States
3
Site 26
Tucson, Arizona, United States
4
Site 5
Jonesboro, Arkansas, United States