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The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levonorgestrel/ethinyl estradiol | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle |
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Inclusion Criteria:
Exclusion Criteria:
Other exclusions apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor, MD | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | 85251 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22067793 | Derived | Halbreich U, Freeman EW, Rapkin AJ, Cohen LS, Grubb GS, Bergeron R, Smith L, Mirkin S, Constantine GD. Continuous oral levonorgestrel/ethinyl estradiol for treating premenstrual dysphoric disorder. Contraception. 2012 Jan;85(1):19-27. doi: 10.1016/j.contraception.2011.05.008. Epub 2011 Jul 13. |
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| Tucson |
| Arizona |
| 85715 |
| United States |
| Jonesboro | Arkansas | 72401 | United States |
| Little Rock | Arkansas | 72205 | United States |
| Carmichael | California | 95608 | United States |
| Los Angeles | California | 90095 | United States |
| San Diego | California | 92103 | United States |
| Denver | Colorado | 80202 | United States |
| Lakewood | Colorado | 80228 | United States |
| Longmont | Colorado | 80501 | United States |
| Middletown | Connecticut | 06457 | United States |
| New Haven | Connecticut | 06510 | United States |
| Waterbury | Connecticut | 06708 | United States |
| Washington D.C. | District of Columbia | 20037 | United States |
| Adventure | Florida | 33180 | United States |
| Clearwater | Florida | 33761 | United States |
| Fort Myers | Florida | 33916 | United States |
| Hialeah | Florida | 33016 | United States |
| Pembroke Pines | Florida | 33024 | United States |
| West Palm Beach | Florida | 33407 | United States |
| Atlanta | Georgia | 30328 | United States |
| Atlanta | Georgia | 30342 | United States |
| Savannah | Georgia | 31406 | United States |
| Boise | Idaho | 83712 | United States |
| Chicago | Illinois | 60631 | United States |
| Chicago | Illinois | 60634 | United States |
| Evansville | Indiana | 47714 | United States |
| South Bend | Indiana | 46601 | United States |
| Lexington | Kentucky | 40509 | United States |
| New Orleans | Louisiana | 70114 | United States |
| Glen Burnie | Maryland | 21061 | United States |
| Boston | Massachusetts | 02114 | United States |
| Pittsfield | Massachusetts | 01201 | United States |
| Springfield | Massachusetts | 01107 | United States |
| Brooklyn | New York | 11235 | United States |
| Buffalo | New York | 14214 | United States |
| New York | New York | 10021 | United States |
| Rochester | New York | 14609 | United States |
| Fayetteville | North Carolina | 28304 | United States |
| New Bern | North Carolina | 28562 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Cincinnati | Ohio | 45219 | United States |
| Cleveland | Ohio | 44122 | United States |
| Mogadore | Ohio | 44260 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Tulsa | Oklahoma | 74135 | United States |
| Eugene | Oregon | 97401 | United States |
| Medford | Oregon | 97504 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Wexford | Pennsylvania | 15090 | United States |
| East Providence | Rhode Island | 02914 | United States |
| Greer | South Carolina | 29654 | United States |
| Hilton Head Island | South Carolina | 29926 | United States |
| Nashville | Tennessee | 37203 | United States |
| Austin | Texas | 78756 | United States |
| Carrollton | Texas | 75010 | United States |
| Conroe | Texas | 77304 | United States |
| San Antonio | Texas | 78229 | United States |
| Salt Lake City | Utah | 84107 | United States |
| Sandy City | Utah | 84070 | United States |
| Burlington | Vermont | 05401 | United States |
| Charlottesville | Virginia | 22903 | United States |
| Norfolk | Virginia | 23502 | United States |
| Richmond | Virginia | 23230 | United States |
| Richmond | Virginia | 23233 | United States |
| Richmond | Virginia | 23294 | United States |
| Lakewood | Washington | 98499 | United States |
| Renton | Washington | 98055 | United States |
| Edmonton | Alberta | T6G 2C8 | Canada |
| Edmonton | Alberta | T6L 5X8 | Canada |
| Kelowna | British Columbia | V1Y 2H4 | Canada |
| Vancouver | British Columbia | V6H 3N1 | Canada |
| Hamilton | Ontario | L8N 4A6 | Canada |
| Toronto | Ontario | M9W 4L6 | Canada |
| Hull | Quebec | J9A 1K7 | Canada |
| Montréal | Quebec | H1T 1P6 | Canada |
| Montréal | Quebec | H3A 1A1 | Canada |
| Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Québec | Quebec | G1R 2W8 | Canada |
| Québec | Quebec | G1S 2L6 | Canada |
| Shawinigan | Quebec | G9N 2H6 | Canada |
| Sherbrooke | Quebec | J1H 4J6 | Canada |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D011293 | Premenstrual Syndrome |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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