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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.
Currently available methods of emergency contraception (EC) only work during a very narrow time period prior to the hormonal trigger for ovulation or the release of an egg. Women having unprotected sex outside this window receive no benefits from this emergency therapy. Prostaglandins are critical before, during, and after ovulation, thus their inhibition may cause an EC effect that works over a longer time period. We wanted to determine if celecoxib might work as an EC with a wider window of action.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celebrex | Drug | One 400mg tablet daily. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Menstrual Cycle Length | Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Edelman, MD, MPH | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
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| Label | URL |
|---|---|
| OHSU Women's Health Research Unit | View source |
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Potential subjects may also have learned about the study from an OHSU Center for Women's Health provider.Visit 1: reviewed of medical history and demographics and vital signs. A blood draw and urine pregnancy test was performed. Eligible subjects returned for the enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Drug Cycle | Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle |
| FG001 | Placebo | Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
One tablet daily. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Drug Cycle | Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle |
| BG001 | Placebo | Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Menstrual Cycle Length | Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry. | Intention to Treat (ITT) | Posted | Mean | Standard Deviation | Days | 3 months |
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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 | Active Drug Cycle | Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle | 0 | 11 | 0 | 11 | ||
| EG001 | Placebo | Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle | 0 | 11 | 0 | 11 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison Edelman, MD, MPH | Oregon Health and Sciences University | 503-494-5949 | edelmana@ohsu.edu |
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|