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

Information source: Solvay Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Secondary Amenorrhea

Intervention: PROMETRIUM® 300 mg (Drug); PROMETRIUM® 400 mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Secretory Conversion of the Endometrium

Number of Subjects With Withdrawal Bleeding

Secondary outcome:

Maximum Intensity of Withdrawal Bleeding After Any Cycle

The Duration of Withdrawal Bleeding After the First Treatment Cycle

The Duration of Withdrawal Bleeding After Second Treatment Cycle

Time to Withdrawal Bleeding After First Treatment Cycle

Time to Withdrawal Bleeding After Second Treatment Cycle

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

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

Site 23, New Bern, North Carolina, United States

Site 15, Winston-Salem, North Carolina, United States

Site 28, Winston-Salem, North Carolina, United States

Site 33, Cincinnati, Ohio, United States

Site 32, Erie, Pennsylvania, United States

Site 47, Hershey, Pennsylvania, United States

Site 44, Philadelphia, Pennsylvania, United States

Site 38, Pottstown, Pennsylvania, United States

Site 13, Greenville, South Carolina, United States

Site 8, Conroe, Texas, United States

Site 11, Corpus Christi, Texas, United States

Site 27, Houston, Texas, United States

Site 34, Houston, Texas, United States

Site 24, San Antonio, Texas, United States

Site 35, Salt Lake City, Utah, United States

Site 19, Norfolk, Virginia, United States

Site 4, Seattle, Washington, United States

Additional Information

Starting date: November 2004
Last updated: June 30, 2010

Page last updated: August 23, 2015

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