Secondary Amenorrhea Clinical Trial
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
| Verified date | June 2010 |
| Source | Solvay Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea
| Status | Completed |
| Enrollment | 240 |
| Est. completion date | February 2009 |
| Est. primary completion date | February 2009 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Site 46 | Atlanta | Georgia |
| United States | Site 14 | Aventura | Florida |
| United States | Site 42 | Avon | Connecticut |
| United States | Site 7 | Baltimore | Maryland |
| United States | Site 6 | Baton Rouge | Louisiana |
| United States | Site 39 | Carmichael | California |
| United States | Site 36 | Champaign | Illinois |
| United States | Site 12 | Chicago | Illinois |
| United States | Site 33 | Cincinnati | Ohio |
| United States | Site 40 | Clearwater | Florida |
| United States | Site 8 | Conroe | Texas |
| United States | Site 11 | Corpus Christi | Texas |
| United States | Site 17 | Encinitas | California |
| United States | Site 32 | Erie | Pennsylvania |
| United States | Site 13 | Greenville | South Carolina |
| United States | Site 3 | Groton | Connecticut |
| United States | Site 47 | Hershey | Pennsylvania |
| United States | Site 27 | Houston | Texas |
| United States | Site 34 | Houston | Texas |
| United States | Site 5 | Jonesboro | Arkansas |
| United States | Site 29 | Mobile | Alabama |
| United States | Site 41 | Montgomery | Alabama |
| United States | Site 23 | New Bern | North Carolina |
| United States | Site 22 | New Britian | Connecticut |
| United States | Site 45 | New York | New York |
| United States | Site 19 | Norfolk | Virginia |
| United States | Site 44 | Philadelphia | Pennsylvania |
| United States | Site 38 | Pottstown | Pennsylvania |
| United States | Site 43 | Powder Springs | Georgia |
| United States | Site 16 | Reno | Nevada |
| United States | Site 35 | Salt Lake City | Utah |
| United States | Site 24 | San Antonio | Texas |
| United States | Site 10 | San Diego | California |
| United States | Site 4 | Seattle | Washington |
| United States | Site 2 | St. Louis | Missouri |
| United States | Site 26 | Tucson | Arizona |
| United States | Site 9 | Waterbury | Connecticut |
| United States | Site 37 | West Hartford | Connecticut |
| United States | Site 1 | West Palm Beach | Florida |
| United States | Site 30 | West Palm Beach | Florida |
| United States | Site 15 | Winston-Salem | North Carolina |
| United States | Site 28 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Solvay Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Secretory Conversion of the Endometrium | Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria. | End of the study (Days 85) | No |
| Primary | Number of Subjects With Withdrawal Bleeding | This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle. | After first and second cycle (cycle=28 days) | No |
| Secondary | Maximum Intensity of Withdrawal Bleeding After Any Cycle | The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy | Duration of withdrawal bleed | No |
| Secondary | The Duration of Withdrawal Bleeding After the First Treatment Cycle | The numbers of days the subjects actually bled after the end of the first treatment cycle. | End of the first cycle of treatment (cycle=28 days) | No |
| Secondary | The Duration of Withdrawal Bleeding After Second Treatment Cycle | The numbers of days the subjects actually bled after the end of the second treatment cycle | End of the second cycle of treatment (cycle=28 days) | No |
| Secondary | Time to Withdrawal Bleeding After First Treatment Cycle | The number of days between the first cycle of treatment and the withdrawal bleeding. | End of the first cycle of treatment (cycle=28 days) | No |
| Secondary | Time to Withdrawal Bleeding After Second Treatment Cycle | The number of days between the second cycle of treatment and the withdrawal bleeding | End of the second cycle of treatment (cycle=28 days) | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02019589 -
A Phase 3, Randomized, Three-Cycle, Double-Blind, Placebo-Controlled Study to Evaluate Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding for Secondary Amenorrhea
|
Phase 3 |