The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle
Overview[ - collapse ][ - ]
Purpose | The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women. |
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Condition | Ovulation (Follicular Rupture Yes/no) Menstrual Cycles (Total Length, Bleeding Days) Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P) |
Intervention | Drug: Celebrex Drug: Placebo |
Phase | N/A |
Sponsor | Oregon Health and Science University |
Responsible Party | Oregon Health and Science University |
ClinicalTrials.gov Identifier | NCT00614406 |
First Received | January 31, 2008 |
Last Updated | December 11, 2012 |
Last verified | December 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | January 31, 2008 |
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Last Updated Date | December 11, 2012 |
Start Date | January 2008 |
Estimated Primary Completion Date | August 2008 |
Current Primary Outcome Measures | Menstrual Cycle Length [Time Frame: 3 months] [Designated as safety issue: No]Menstrual cycle length was measured by the number of days subjects noted menstruating in their diary entry. |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle |
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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. |
Detailed Description | 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. |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic |
Condition |
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Intervention | Drug: Celebrex One 400mg tablet daily. Drug: Placebo One tablet daily. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 11 |
Estimated Completion Date | August 2008 |
Estimated Primary Completion Date | August 2008 |
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 |
Ages | 18 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00614406 |
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Other Study ID Numbers | OHSU FAMPLAN 3854 |
Has Data Monitoring Committee | No |
Information Provided By | Oregon Health and Science University |
Study Sponsor | Oregon Health and Science University |
Collaborators | Society of Family Planning |
Investigators | Principal Investigator: Alison Edelman, MD, MPH Oregon Health and Science University |
Verification Date | December 2012 |
Locations[ + expand ][ + ]
Oregon Health & Science University | Portland, Oregon, United States, 97239 |
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