Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion
- Conditions
- Secondary Amenorrhea
- Interventions
- Registration Number
- NCT00160199
- Lead Sponsor
- Solvay Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 240
- Women with secondary amenorrhea
- Normal serum Dehydroepiandrosterone (DHEA), prolactin, testosterone, Thyroid Stimulating Hormone (TSH) and thyroxine
- Primary amenorrhea
- Other medical conditions resulting in amenorrhea (e.g. Asherman's syndrome)
- Peanut allergy
- Allergy to progestational steroids
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 PROMETRIUM® 400 mg - 1 PROMETRIUM® 300 mg -
- Primary Outcome Measures
Name Time Method Secretory Conversion of the Endometrium End of the study (Days 85) Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.
Number of Subjects With Withdrawal Bleeding After first and second cycle (cycle=28 days) This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.
- Secondary Outcome Measures
Name Time Method The Duration of Withdrawal Bleeding After Second Treatment Cycle End of the second cycle of treatment (cycle=28 days) The numbers of days the subjects actually bled after the end of the second treatment cycle
Maximum Intensity of Withdrawal Bleeding After Any Cycle Duration of withdrawal bleed The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy
The Duration of Withdrawal Bleeding After the First Treatment Cycle End of the first cycle of treatment (cycle=28 days) The numbers of days the subjects actually bled after the end of the first treatment cycle.
Time to Withdrawal Bleeding After First Treatment Cycle End of the first cycle of treatment (cycle=28 days) The number of days between the first cycle of treatment and the withdrawal bleeding.
Time to Withdrawal Bleeding After Second Treatment Cycle End of the second cycle of treatment (cycle=28 days) The number of days between the second cycle of treatment and the withdrawal bleeding
Trial Locations
- Locations (42)
Site 7
🇺🇸Baltimore, Maryland, United States
Site 16
🇺🇸Reno, Nevada, United States
Site 14
🇺🇸Aventura, Florida, United States
Site 6
🇺🇸Baton Rouge, Louisiana, United States
Site 15
🇺🇸Winston-Salem, North Carolina, United States
Site 41
🇺🇸Montgomery, Alabama, United States
Site 36
🇺🇸Champaign, Illinois, United States
Site 3
🇺🇸Groton, Connecticut, United States
Site 37
🇺🇸West Hartford, Connecticut, United States
Site 29
🇺🇸Mobile, Alabama, United States
Site 39
🇺🇸Carmichael, California, United States
Site 46
🇺🇸Atlanta, Georgia, United States
Site 42
🇺🇸Avon, Connecticut, United States
Site 40
🇺🇸Clearwater, Florida, United States
Site 9
🇺🇸Waterbury, Connecticut, United States
Site 23
🇺🇸New Bern, North Carolina, United States
Site 5
🇺🇸Jonesboro, Arkansas, United States
Site 30
🇺🇸West Palm Beach, Florida, United States
Site 26
🇺🇸Tucson, Arizona, United States
Site 43
🇺🇸Powder Springs, Georgia, United States
Site 45
🇺🇸New York, New York, United States
Site 19
🇺🇸Norfolk, Virginia, United States
Site 12
🇺🇸Chicago, Illinois, United States
Site 27
🇺🇸Houston, Texas, United States
Site 4
🇺🇸Seattle, Washington, United States
Site 10
🇺🇸San Diego, California, United States
Site 33
🇺🇸Cincinnati, Ohio, United States
Site 24
🇺🇸San Antonio, Texas, United States
Site 35
🇺🇸Salt Lake City, Utah, United States
Site 17
🇺🇸Encinitas, California, United States
Site 22
🇺🇸New Britian, Connecticut, United States
Site 1
🇺🇸West Palm Beach, Florida, United States
Site 2
🇺🇸St. Louis, Missouri, United States
Site 47
🇺🇸Hershey, Pennsylvania, United States
Site 28
🇺🇸Winston-Salem, North Carolina, United States
Site 13
🇺🇸Greenville, South Carolina, United States
Site 34
🇺🇸Houston, Texas, United States
Site 8
🇺🇸Conroe, Texas, United States
Site 32
🇺🇸Erie, Pennsylvania, United States
Site 11
🇺🇸Corpus Christi, Texas, United States
Site 38
🇺🇸Pottstown, Pennsylvania, United States
Site 44
🇺🇸Philadelphia, Pennsylvania, United States