| Original Study ID : OHSU FAMPLAN 3854 |
| NCT ID : NCT00614406 |
| Brief Title : The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle |
| Official Title : The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle. |
| Brief Summary : The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women. |
| Source : Oregon Health and Science University |
| Overall Status : Completed |
| Start Date : January 2008 |
| End Date : August 2008 |
| Completion Date : August 2008 |
| Official Title : N/A |
| Phase : Interventional |
| Study Design : Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Enrollment : 16 |
| Verification Date : February 2009 |
| First Received Date : January 31, 2008 |
| Trial Eligibility |
| Criteria : Inclusion Criteria: - Age 18-35 - Normal menstrual periods (24-35 days) - Good general health - Willing to use a non-hormonal form of contraception for the entire study (Acceptable forms of contraception include condoms, spermicide, sexual contact with a sterilized partner, subject is surgically sterile, same-sex partner, Copper IUD and abstinence) - Willing and able to return to clinic for bi-weekly blood tests Exclusion Criteria: - Pregnant or breast feeding - Polycystic ovarian disease - Gastrointestinal conditions (i.e.gastric ulcer) - Currently using birth control - Known allergy to aspirin, non-steroidal anti-inflammatory drugs (NSAIDS) or Sulfa-drugs - Diabetes - Cardiac disease or hypertension - Moderate to severe heartburn (GERD) - Obesity (BMI greater than 30) |
| Gender : Female |
| Minimum Age : 18 Years |
| Maximum Age : 35 Years |
| Healthy Volunteers : Accepts He |
| Facilities |
| Facility Name : Oregon Health & Science University |
| City : Portland |
| State : Oregon |
| Zip Code : 97239 |
| Country : United States |
| OutComes |
| Primary OutComes |
| Measure : Progesterone levels |
| Time Frame : Completion of study |
| Safety issue : No |
| Secondary OutComes |
| Measure : Menstrual cycle length |
| Time Frame : Study completion |
| Safety issue : No |
| Interventions |
| Type : Drug |
| Name : Celebrex |
| Description : One 400mg tablet daily. |
| Type : Drug |
| Name : Placebo |
| Description : One tablet daily. |
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