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To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROMETRIUM® 300 mg | Drug | 300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The Duration of Withdrawal Bleeding After the First Treatment Cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 29 | Mobile | Alabama | United States | |||
| Site 41 |
The Baseline characteristics are presented using the Full Analysis Sample (FAS) to be online with the Efficacy analysis results.
Subjects were recruited in 42 centers in US between November 2004 and February 2009. Before the randomization, subjects were evaluated for eligibility. In total 240 subjects were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prometrium 300 mg/Day | |
| FG001 | Prometrium 400 mg/Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PROMETRIUM® 400 mg | Drug | 400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles |
|
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) |
| 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) |
| 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) |
| 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) |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prometrium 300 mg/Day | |
| BG001 | Prometrium 400 mg/Day | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | The participant flow chart was done on all Randomized subjects set (i.e. subjects who received at least one dose of open-label study medication) . The baseline results are presented on the Full Analysis set (i.e. subjects randomized with at least one post-baseline evaluable efficacy assessment). | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | The participant flow chart was done on all Randomized subjects set (i.e. subjects who received at least one dose of open-label study medication) . The baseline results are presented on the Full Analysis set (i.e. subjects randomized with at least one post-baseline evaluable efficacy assessment). | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | The participant flow chart was done on all Randomized subjects set (i.e. subjects who received at least one dose of open-label study medication) . The baseline results are presented on the Full Analysis set (i.e. subjects randomized with at least one post-baseline evaluable efficacy assessment). | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated. | Posted | Number | participants | End of the study (Days 85) |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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. | The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated. | Posted | Number | participants | After first and second cycle (cycle=28 days) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Intensity of Withdrawal Bleeding After Any Cycle | The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy | The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated. | Posted | Number | participants | Duration of withdrawal bleed |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated. | Posted | Mean | Standard Deviation | Days | End of the first cycle of treatment (cycle=28 days) |
|
| ||||||||||||||||||||||||||||||||||||
| 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 | The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated. | Posted | Mean | Standard Deviation | Days | End of the second cycle of treatment (cycle=28 days) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Withdrawal Bleeding After First Treatment Cycle | The number of days between the first cycle of treatment and the withdrawal bleeding. | The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated. | Posted | Mean | Standard Deviation | Days | End of the first cycle of treatment (cycle=28 days) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Withdrawal Bleeding After Second Treatment Cycle | The number of days between the second cycle of treatment and the withdrawal bleeding | The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated. | Posted | Mean | Standard Deviation | Days | End of the second cycle of treatment (cycle=28 days) |
|
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The adverse events presented were collected from start of drug treatment to the end of the treatment period.
The safety analysis is presented on the safety sample meaning the number of patients who were randomized and received at least one dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prometrium 300 mg/Day | 2 | 113 | 72 | 113 | |||
| EG001 | Prometrium 400 mg/Day | 1 | 107 | 70 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adnexa uteri mass | Reproductive system and breast disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 7.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acnes | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Asthenic conditions | General disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Breast signs and symptoms | Reproductive system and breast disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Flatulence Bloating and distension | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Fungal infection NEC | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| |
| Gastrointestinal and Abdominal Pains (excl oral and throat) | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Headaches NEC | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Musculoskeletal and connective tissue signs and symptoms NEC | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Nausea and Vomiting | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Neurological signs and symptoms NEC | Nervous system disorders | MedDRA 7.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infections | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
|
Independent analysis and/or publication of these data by the investigator or any member of his/her staff are not permitted without prior written consent of Solvay Pharmaceuticals,Inc. Written permission will be contingent on the review by Solvay Pharmaceuticals, Inc. of the statistical analysis and manuscript and providing for non-disclosure of Solvay Pharmaceuticals, Inc. confidential or proprietary information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sven Voet - Global Communication | Solvay Pharmaceuticals | +32(0)2 509 69 77 | sven.voet@solvay.com |
| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
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| Male |
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| Unable to determine |
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| Unknown |
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