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Clinical Trial Name - The Effects of a Prostaglandin Inhibitor on Ovulation and the Menstrual Cycle

 
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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